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162 results on '"Cagnazzo, Celeste"'

1. Prolonged 14-day continuous infusion of high-dose ifosfamide for patients with relapsed and refractory high-grade osteosarcoma: a retrospective multicentre cohort study

Author

Tirtei, Elisa, Campello, Anna, Sciannameo, Veronica, Asaftei, Sebastian Dorin, Meazza, Cristina, Sironi, Giovanna, Longhi, Alessandra, Ibrahim, Toni, Tamburini, Angela, Coccoli, Luca, Crocco, Fanj, Cagnazzo, Celeste, De Luna, Elvira, Quarello, Paola, Berchialla, Paola, and Fagioli, Franca

Published
2024
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3. Adherence of systematic reviews to Cochrane RoB2 guidance was frequently poor: a meta epidemiological study

Author

Cianciulli, Angelo, Cinnirella, Andrea, Grosso, Francesca, Luceri, Francesco, Venuti, Giuseppe, Vultaggio, Stefania, Zambarbieri, Emiliano, Minozzi, Silvia, Gonzalez-Lorenzo, Marien, Cinquini, Michela, Berardinelli, Daniela, Cagnazzo, Celeste, Ciardullo, Stefano, De Nardi, Paola, Gammone, Mariarosaria, Iovino, Paolo, Lando, Alex, Rissone, Marco, Simeone, Giovanni, Stracuzzi, Marta, Venezia, Giovanna, Moja, Lorenzo, and Costantino, Giorgio

Published
2022
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14. Mind the gap with Europe. Why public interest cannot be a good reason to perform observational and epidemiological research?

Author

Cagnazzo, Celeste, Ficara, Bruno, Palermo, Federica, and Fagioli, Franca

Abstract

The consequences of the Italian privacy legislation, that represents a very restrictive implementation of the general European regulation on data protection, have mainly been felt at the level of observational research. In this field is not always possible to obtain the consent of subjects, and as for retrospective studies, it is not currently clear which is the correct regulatory procedure to follow. This uncertainty in the law’s implementation has given way to multiple interpretations, making it difficult to obtain a homogeneous path in Italy. However, it is possible that the observation point has been totally wrong so far and that it would be more correct to choose a different legal bases than consent, both to preserve scientific progress and collective ethics, without losing the protection of the subject. This approach, which has already been followed by other European countries, could bring us closer to the rest of Europe and allow us to competitively participate in community projects that we are often cut off from.

Published
2024
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15. Clinical trial units and clinical research coordinators: a system facing crisis?

Author

Stabile, Stefano, Cenna, Rosita, Sinna, Valentina, Veronica, Franchina, Mannozzi, Francesca, Federici, Irene, Testoni, Sara, Cagnazzo, Celeste, Stabile, Stefano, Cenna, Rosita, Sinna, Valentina, Veronica, Franchina, Mannozzi, Francesca, Federici, Irene, Testoni, Sara, and Cagnazzo, Celeste

Abstract

We are currently witnessing an increase in procedural and managerial complexities within the field of clinical research, which require greater human and infrastructural resources as well as imply the need for a greater skill set and expertise on the part of professionals. Within this frame of reference clinical trial units and clinical research coordinators play a vital role in the design and conduct of clinical trials in Italy. There is a current recruitment and retention crisis for this specialist role due to a complex set of factors, most likely to have come to a head due to the lack of recognition at the Italian institutional level, that lead to precarious work contracts, lack of identity, and excessive turnover at experimental sites. This article, led by the Italian Group of Clinical Research Coordinator (GIDMcrc), presents some of the issues and ways in which national stakeholders may be able to address this.

Published
2023

16. Clinical research: the great absentee of the Italian University training programs?

Author

Stabile, Stefano, Franchina, Veronica, Cenna, Rosita, Sinno, Valentina, Mannozzi, Francesca, Federici, Irene, Testoni, Sara, Cagnazzo, Celeste, Stabile, Stefano, Franchina, Veronica, Cenna, Rosita, Sinno, Valentina, Mannozzi, Francesca, Federici, Irene, Testoni, Sara, and Cagnazzo, Celeste

Abstract

Background: In an era where clinical trials have become more and more complex and regulatory authorities impose very high quality standards, the education of clinical research professionals becomes crucial. As one of ICH-GCP guiding principles, adequate training should be ensured and included in educational programs. Methods: In 2021, the Italian Group of Data Managers and Clinical Research Coordinators shared among professionals involved in clinical research an online survey aimed at investigating quality and characteristics of clinical research training provided during undergraduate and postgraduate Italian programs. Results: The survey was completed by 280 professionals: 178 study coordinators, 29 clinical research associates, 20 project managers, 7 study nurses, and 44 others. The majority were 25-45 years old (n = 242, 86.4%), worked at experimental sites (n = 211, 75.4%), and almost all (n = 252, 90.0%) had at least a master’s degree, mainly in biology/biotechnology (n = 162, 57.9%) and pharmacy (n = 64, 22.9%). Clinical research education during the degree courses was considered poor by 73.6% (n = 206). The knowledge on clinical research professional world at the time of graduation was considered poor by 71.1% of participants (n = 199), like the knowledge of related career opportunities (71.1%, n = 199, poor). According to 85.0% of professionals (n = 238) additional postgraduate trainings were needed, mainly university master courses (47.50%, n = 133) and private institution courses (47.86%, n = 134). Postgraduate trainings were considered very useful by 71.4% (n = 200) of responders. Conclusion: Our data suggest undergraduate programs on clinical research education failing at providing even the basic information on clinical research. Therefore, most professionals resort to specific additional postgraduate courses.

Published
2023

17. How to manage symptoms in pediatric cancer patients enrolled in clinical trials? A review of principal patient-reported outcome screening tools

Author

Zucchetti , Giulia, Cagnazzo, Celeste, Ciappina, Sabrina, Bertorello, Nicoletta, Resente , Francesca, Spadea , Manuela, Ceolin, Valeria, Fagioli, Franca, Zucchetti , Giulia, Cagnazzo, Celeste, Ciappina, Sabrina, Bertorello, Nicoletta, Resente , Francesca, Spadea , Manuela, Ceolin, Valeria, and Fagioli, Franca

Abstract

Background: In adult oncology, the practice of tracking symptoms and toxicities using patient-reported outcomes (PROs) has increased and correlates with increased survival. In contrast, symptom monitoring using PROs is not common in pediatric oncology. Only in the last couple of years attention has also been paid to the patient’s perception in pediatrics and listening to the voice of children and to making them participate in the treatment. Methods: A comprehensive literature search was conducted in MEDLINE/PubMed and PsycINFO to identify relevant articles published through December 2022. Results: From 58 non-duplicate articles, 33 met our eligibility criteria. Of these, 17 were used in clinical trials. Conclusions: The dissemination and use of these tools will therefore have surprising repercussions on the control of pain and physical symptoms of small patients as well as on physical and psychological aspects. The administration and use of the PROs ensures optimal use of the drugs currently present in clinical trials by researcher and nurse and aims at a safer and more controlled approval of new drugs.

Published
2023

21. Fluoropyrimidine‑induced cardiotoxicity in colorectal cancer patients: a prospective observational trial (CHECKPOINT)

Author

Lombardi, Pasquale, primary, Aimar, Giacomo, additional, Peraldo‑Neia, Caterina, additional, Bonzano, Alessandro, additional, Depetris, Ilaria, additional, Fenocchio, Elisabetta, additional, Filippi, Roberto, additional, Quarà, Virginia, additional, Milanesio, Michela, additional, Cavalloni, Giuliana, additional, Gammaitoni, Loretta, additional, Basiricò, Marco, additional, Cagnazzo, Celeste, additional, Ostano, Paola, additional, Chiorino, Giovanna, additional, Aglietta, Massimo, additional, and Leone, Francesco, additional

Published
2022
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22. Adherence of systematic reviews to Cochrane RoB2 guidance was frequently poor: a meta epidemiological study

Author

Minozzi, Silvia, primary, Gonzalez-Lorenzo, Marien, additional, Cinquini, Michela, additional, Berardinelli, Daniela, additional, Cagnazzo, Celeste, additional, Ciardullo, Stefano, additional, De Nardi, Paola, additional, Gammone, Mariarosaria, additional, Iovino, Paolo, additional, Lando, Alex, additional, Rissone, Marco, additional, Simeone, Giovanni, additional, Stracuzzi, Marta, additional, Venezia, Giovanna, additional, Moja, Lorenzo, additional, Costantino, Giorgio, additional, Cianciulli, Angelo, additional, Cinnirella, Andrea, additional, Grosso, Francesca, additional, Luceri, Francesco, additional, Venuti, Giuseppe, additional, Vultaggio, Stefania, additional, and Zambarbieri, Emiliano, additional

Published
2022
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23. [Implementation of the European regulation 536/2014 in Italy: the neverending story.]

Author

Cagnazzo, Celeste

Subjects
Clinical Trials as Topic, Italy, Humans
Abstract

The European regulation 536/2014, unapplied for several years due to the inoperability of the European Portal, represented an epochal turning point in the legislation concerning pharmacological clinical trials. Although, unlike the directive, it could be directly applied without national transpositions, in Italy this has not been possible and for three months now we have been witnessing a haemorrhage of guidelines/operational proposals/decrees that to date do not make us ready to fully operate according to the new rules. Il regolamento europeo 536/20141, in vigore dal 16 giugno 2014 e rimasto per diversi anni non applicato per un ritardo nella messa in funzione del portale unico europeo, ha rappresentato una svolta epocale nella normativa inerente le sperimentazioni cliniche con farmaco. La normativa precedentemente in vigore2, infatti, pur rappresentando la prima trasformazione in legge delle Good Clinical Practices e un primo tentativo di armonizzazione tra le procedure regolatorie dei diversi stati membri, aveva portato a una serie di risvolti negativi, come un aumento vertiginoso dei costi e dei tempi necessari ad avviare uno studio. Tutto ciò, negli anni, si è tradotto in una deflessione delle richieste di autorizzazione delle sperimentazioni e in una grande difformità tra gli stati membri3,4. Il regolamento introduce delle novità mirate a ottimizzare profondamente l'iter regolatorio di approvazione delle sperimentazioni, primo fra tutti il nuovo processo di autorizzazione, che prevede l'espressione di un unico parere a livello europeo e la singola decisione, a livello di singolo stato membro, di accettare o non accettare tale decisione. Il nuovo processo, molto ambizioso da un punto di vista della riduzione dei tempi, doveva rappresentare una occasione storica per l'incremento delle performance di Paesi come l'Italia, da sempre penalizzata da una burocrazia molto complessa e dalla necessità di procedere con molteplici valutazioni da parte dell'autorità competente e di numerosi comitati etici5,6. I ritardi nella messa in funzione del portale, inizialmente prevista per maggio 2016, hanno portato a un lungo e continuo slittamento dei tempi di applicazione del regolamento, alla fine calendarizzata per il 31 gennaio 2022. Sei anni di attesa che, almeno sulla carta, hanno fornito l'occasione a tutti gli stati membri di prepararsi al meglio a tutti i cambiamenti che il regolamento avrebbe comportato.La scelta, da un punto di vista prettamente legale, di un regolamento piuttosto che di una nuova direttiva aveva lo scopo di evitare una ulteriore difformità di azione tra le diverse nazioni; il regolamento, infatti, a differenza della direttiva non necessita di successivi passaggi legislativi a livello nazionale e poteva essere direttamente implementato nei singoli stati membri. Alcune nazioni si sono preparate all'applicazione del regolamento procedendo con una profonda revisione e semplificazione del proprio apparato regolatorio; è il caso, per esempio, della Spagna, che ha optato per un unico decreto in grado di regolare tutti gli aspetti inerenti le sperimentazioni interventistiche con farmaco7.Situazione completamente opposta in Italia, dove l'implementazione della vecchia direttiva aveva causato una emorragia di decreti ministeriali e di altri atti legislativi che difficilmente potevano venire riorganizzati, come accaduto in Spagna, in un unico atto. Uno stato che ha portato, ancora una volta e forse in maniera ancora più complessa di quanto accaduto a inizio millennio, a un lungo processo di riorganizzazione legislativa, avviato con il decreto Lorenzin e ancora molto lontano dall'essere completato con tutti i decreti attuativi necessari.

Published
2022

25. Adherence of systematic reviews to Cochrane RoB2 guidance was frequently poor: a meta epidemiological study

Author

Minozzi, S, Gonzalez-Lorenzo, M, Cinquini, M, Berardinelli, D, Cagnazzo, C, Ciardullo, S, De Nardi, P, Gammone, M, Iovino, P, Lando, A, Rissone, M, Simeone, G, Stracuzzi, M, Venezia, G, Moja, L, Costantino, G, Minozzi, Silvia, Gonzalez-Lorenzo, Marien, Cinquini, Michela, Berardinelli, Daniela, Cagnazzo, Celeste, Ciardullo, Stefano, De Nardi, Paola, Gammone, Mariarosaria, Iovino, Paolo, Lando, Alex, Rissone, Marco, Simeone, Giovanni, Stracuzzi, Marta, Venezia, Giovanna, Moja, Lorenzo, Costantino, Giorgio, Minozzi, S, Gonzalez-Lorenzo, M, Cinquini, M, Berardinelli, D, Cagnazzo, C, Ciardullo, S, De Nardi, P, Gammone, M, Iovino, P, Lando, A, Rissone, M, Simeone, G, Stracuzzi, M, Venezia, G, Moja, L, Costantino, G, Minozzi, Silvia, Gonzalez-Lorenzo, Marien, Cinquini, Michela, Berardinelli, Daniela, Cagnazzo, Celeste, Ciardullo, Stefano, De Nardi, Paola, Gammone, Mariarosaria, Iovino, Paolo, Lando, Alex, Rissone, Marco, Simeone, Giovanni, Stracuzzi, Marta, Venezia, Giovanna, Moja, Lorenzo, and Costantino, Giorgio

Abstract

Objectives: To assess whether the use of the revised Cochrane risk of bias tool for randomized trials (RoB2) in systematic reviews (SRs) adheres to RoB2 guidance. Methods: We searched MEDLINE, Embase, Cochrane Library from 2019 to May 2021 to identify SRs using RoB2. We analyzed methods and results sections to see whether risk of bias was assessed at outcome measure level and applied to primary outcomes of the SR as per RoB2 guidance. The relation between SR characteristics and adequacy of RoB2 use was examined by logistic regression analysis. Results: Two hundred-eight SRs were included. We could assess adherence in 137 SRs as 12 declared using RoB2 but actually used RoB1 and 59 did not report the number of primary outcomes. The tool usage was adherent in 69.3% SRs. Considering SRs with multiple primary outcomes, adherence dropped to 28.8%. We found a positive association between RoB2 guidance adherence and the methodological quality of the reviews assessed by AMSTAR2 (p-for-trend 0.007). Multivariable regression analysis suggested journal impact factor [first quartile vs. other quartiles] was associated with RoB2 adherence (OR 0.34; 95% CI: 0.16-0.72). Conclusions: Many SRs did not adhere to RoB2 guidance as they applied the tool at the study level rather than at the outcome measure level. Lack of adherence was more likely among low and very low quality reviews.

Published
2022

26. Temozolomide Followed by Combination With Low-Dose Ipilimumab and Nivolumab in Patients With Microsatellite-Stable, O6-Methylguanine-DNA Methyltransferase-Silenced Metastatic Colorectal Cancer: The MAYA Trial

Author

Morano, Federica, Raimondi, Alessandra, Pagani, Filippo, Lonardi, Sara, Salvatore, Lisa, Cremolini, Chiara, Murgioni, Sabina, Randon, Giovanni, Palermo, Federica, Antonuzzo, Lorenzo, Pella, Nicoletta, Racca, Patrizia, Prisciandaro, Michele, Niger, Monica, Corti, Francesca, Bergamo, Francesca, Zaniboni, Alberto, Ratti, Margherita, Palazzo, Michele, Cagnazzo, Celeste, Calegari, Maria Alessandra, Marmorino, Federica, Capone, Iolanda, Conca, Elena, Busico, Adele, Brich, Silvia, Tamborini, Elena, Perrone, Federica, Di Maio, Massimo, Milione, Massimo, Di Bartolomeo, Maria, de Braud, Filippo, Pietrantonio, Filippo, Morano, Federica, Raimondi, Alessandra, Pagani, Filippo, Lonardi, Sara, Salvatore, Lisa, Cremolini, Chiara, Murgioni, Sabina, Randon, Giovanni, Palermo, Federica, Antonuzzo, Lorenzo, Pella, Nicoletta, Racca, Patrizia, Prisciandaro, Michele, Niger, Monica, Corti, Francesca, Bergamo, Francesca, Zaniboni, Alberto, Ratti, Margherita, Palazzo, Michele, Cagnazzo, Celeste, Calegari, Maria Alessandra, Marmorino, Federica, Capone, Iolanda, Conca, Elena, Busico, Adele, Brich, Silvia, Tamborini, Elena, Perrone, Federica, Di Maio, Massimo, Milione, Massimo, Di Bartolomeo, Maria, de Braud, Filippo, and Pietrantonio, Filippo

Abstract

N/A

Published
2022

28. Gemcitabine-docetaxel in patients with relapsed high-grade osteosarcoma after first-line treatment with high-dose ifosfamide: A retrospective multicenter study.

Author

Pionelli, Maria Grazia, primary, Asaftei, Sebastian Dorin, additional, Meazza, Cristina, additional, Longhi, Alessandra, additional, Tamburini, Angela, additional, Coccoli, Luca, additional, Merlini, Alessandra, additional, Cagnazzo, Celeste, additional, Tirtei, Tirtei, additional, and Fagioli, Franca, additional

Published
2022
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29. Temozolomide Followed by Combination With Low-Dose Ipilimumab and Nivolumab in Patients With Microsatellite-Stable, O6-Methylguanine–DNA Methyltransferase–Silenced Metastatic Colorectal Cancer: The MAYA Trial

Author

Morano, Federica, primary, Raimondi, Alessandra, additional, Pagani, Filippo, additional, Lonardi, Sara, additional, Salvatore, Lisa, additional, Cremolini, Chiara, additional, Murgioni, Sabina, additional, Randon, Giovanni, additional, Palermo, Federica, additional, Antonuzzo, Lorenzo, additional, Pella, Nicoletta, additional, Racca, Patrizia, additional, Prisciandaro, Michele, additional, Niger, Monica, additional, Corti, Francesca, additional, Bergamo, Francesca, additional, Zaniboni, Alberto, additional, Ratti, Margherita, additional, Palazzo, Michele, additional, Cagnazzo, Celeste, additional, Calegari, Maria Alessandra, additional, Marmorino, Federica, additional, Capone, Iolanda, additional, Conca, Elena, additional, Busico, Adele, additional, Brich, Silvia, additional, Tamborini, Elena, additional, Perrone, Federica, additional, Di Maio, Massimo, additional, Milione, Massimo, additional, Di Bartolomeo, Maria, additional, de Braud, Filippo, additional, and Pietrantonio, Filippo, additional

Published
2022
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33. Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer

Author

Montemurro, Filippo, Mittica, Gloria, Cagnazzo, Celeste, Longo, Virginia, Berchialla, Paola, Solinas, Gianfranca, Culotta, Paola, Martinello, Rossella, Foresto, Manuela, Gallizioli, Simona, Calori, Adele, Grasso, Bruna, Volpone, Chiara, Bertola, Gisella, Parola, Gisella, Tealdi, Giancarla, Giuliano, Piero Luigi, Aglietta, Massimo, and Ballari, Anna Maria

Published
2016
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34. Panitumumab in combination with gemcitabine and oxaliplatin does not prolong survival in wild-type KRAS advanced biliary tract cancer: A randomized phase 2 trial (Vecti-BIL study)

Author

Leone, Francesco, Marino, Donatella, Cereda, Stefano, Filippi, Roberto, Belli, Carmen, Spadi, Rosella, Nasti, Guglielmo, Montano, Massimo, Amatu, Alessio, Aprile, Giuseppe, Cagnazzo, Celeste, Fasola, Gianpiero, Siena, Salvatore, Ciuffreda, Libero, Reni, Michele, and Aglietta, Massimo

Published
2016
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40. Cancer patients’ awareness about clinical research in the era of social media and “fake news”: Preliminary results from ELPIS Study.

Author

Cagnazzo, Celeste, primary, Franchina, Veronica, additional, Toscano, Giuseppe, additional, Fagioli, Franca, additional, Franchina, Tindara, additional, Ricciardi, Giuseppina Rosaria Rita, additional, Antonuzzo, Lorenzo, additional, Di Costanzo, Alessandro, additional, Russo, Antonio, additional, Cusenza, Stefania, additional, Gori, Stefania, additional, Marchetti, Fabiana, additional, Tambaro, Margherita, additional, Piccirillo, Patrizia, additional, Nanni, Oriana, additional, Cenna, Rosita, additional, Delfanti, Sara, additional, Di Maio, Massimo, additional, Dascanio, Fabio, additional, and Adamo, Vincenzo, additional

Published
2021
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41. Temozolomide Followed by Combination With Low-Dose Ipilimumab and Nivolumab in Patients With Microsatellite-Stable, O6-Methylguanine-DNA Methyltransferase-Silenced Metastatic Colorectal Cancer: The MAYA Trial.

Author

Morano, Federica, Raimondi, Alessandra, Pagani, Filippo, Lonardi, Sara, Salvatore, Lisa, Cremolini, Chiara, Murgioni, Sabina, Randon, Giovanni, Palermo, Federica, Antonuzzo, Lorenzo, Pella, Nicoletta, Racca, Patrizia, Prisciandaro, Michele, Niger, Monica, Corti, Francesca, Bergamo, Francesca, Zaniboni, Alberto, Ratti, Margherita, Palazzo, Michele, and Cagnazzo, Celeste

Published
2022
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42. Panitumumab in combination with infusional oxaliplatin and oral capecitabine for conversion therapy in patients with colon cancer and advanced liver metastases: The MetaPan study

Author

Leone, Francesco, Artale, Salvatore, Marino, Donatella, Cagnazzo, Celeste, Cascinu, Stefano, Pinto, Carmine, Fornarini, Giuseppe, Tampellini, Marco, Di Fabio, Francesca, Sartore-Bianchi, Andrea, De Carlis, Luciano, Pugliese, Raffaele, Capussotti, Lorenzo, Gioeni, Luisa, Siena, Salvatore, and Aglietta, Massimo

Published
2013
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43. Lessons learned from COVID-19 for clinical research operations in Italy: what have we learned and what can we apply in the future?

Author

Cagnazzo, Celeste, primary, Besse, Marie-Georges, additional, Manfellotto, Dario, additional, Minghetti, Paola, additional, Cazzaniga, Sara, additional, Cottini, Lorenzo, additional, Fontanella, Andrea, additional, Maruti, Ilaria, additional, Stabile, Stefano, additional, Testoni, Sara, additional, Trogu, Paola, additional, Sinno, Valentina, additional, and Gussoni, Gualberto, additional

Published
2020
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44. Patient associations and clinical oncology research: how much does a patient’s voice really matter?

Author

Franchina, Veronica, primary, Cagnazzo, Celeste, additional, Di Costanzo, Alessandro, additional, Arizio, Francesca, additional, Frazzetto, Angela Maria Elena, additional, Gori, Stefania, additional, Cenna, Rosita, additional, Nicolis, Fabrizio, additional, Procopio, Giuseppe, additional, Adamo, Vincenzo, additional, La Verde, Nicla, additional, and Nanni, Oriana, additional

Published
2020
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46. The prognostic nutritional index predicts survival and response to first‐line chemotherapy in advanced biliary cancer

Author

Salati, Massimiliano, primary, Filippi, Roberto, additional, Vivaldi, Caterina, additional, Caputo, Francesco, additional, Leone, Francesco, additional, Salani, Francesca, additional, Cerma, Krisida, additional, Aglietta, Massimo, additional, Fornaro, Lorenzo, additional, Sperti, Elisa, additional, Di Maio, Massimo, additional, Ortega, Cinzia, additional, Fenocchio, Elisabetta, additional, Lombardi, Pasquale, additional, Cagnazzo, Celeste, additional, Depetris, Ilaria, additional, Gelsomino, Fabio, additional, Spallanzani, Andrea, additional, Santini, Daniele, additional, Silvestris, Nicola, additional, Aprile, Giuseppe, additional, Roviello, Giandomenico, additional, Scartozzi, Mario, additional, Cascinu, Stefano, additional, and Casadei‐Gardini, Andrea, additional

Published
2019
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47. Patient associations and clinical oncology research: how much does a patient's voice really matter?

Author

Franchina, Veronica, Cagnazzo, Celeste, Di Costanzo, Alessandro, Arizio, Francesca, Frazzetto, Angela Maria Elena, Gori, Stefania, Cenna, Rosita, Nicolis, Fabrizio, Procopio, Giuseppe, Adamo, Vincenzo, La Verde, Nicla, and Nanni, Oriana

Abstract

Background: New trends are emerging in clinical research, such as patient empowerment and an active role in influencing health and research ethics. Patients' involvement is considered pivotal by stakeholders and institutions because they can channel the voice of those they represent, empowering their starring role in the different research activities. Objectives: To obtain an overview of the real involvement of Italian patient associations in clinical research. Methods: In January 2019, the Working Group 'Clinical Research Coordinators' of the Italian Association of Medical Oncology spread an online questionnaire consisting of 16 questions on the active involvement of patient associations in clinical research. Results: The involvement in clinical research working groups, in the organization and implementation of specific activities and training initiatives is very limited (21.7% in both cases), as well as the active involvement in the conduct and/or definition of clinical trials (0.3%). Moreover, few associations (15.2%) have joined projects on patient involvement in clinical research in collaboration with other associations. Discussion: Although the current involvement of the associations may have been somewhat underestimated, there is no doubt that much more can be done in terms of training and identification of common objectives between patients and professionals. [ABSTRACT FROM AUTHOR]

Published
2021
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48. Phase I studies: a test bench for Italian clinical research

Author

Cagnazzo, Celeste, primary, Nanni, Oriana, additional, Arizio, Francesca, additional, Franchina, Veronica, additional, Cenna, Rosita, additional, Tabaro, Gianna, additional, Vannini, Francesca, additional, Procopio, Giuseppe, additional, Gori, Stefania, additional, and Di Costanzo, Alessandro, additional

Published
2019
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49. Improvement of Metastatic Colorectal Cancer Patient Survival: Single Institution Experience

Author

Fenocchio, Elisabetta, primary, Colombi, Federica, additional, Calella, Maria Grazia, additional, Filippi, Roberto, additional, Depetris, Ilaria, additional, Chilà, Giovanna, additional, Lombardi, Pasquale, additional, Marino, Donatella, additional, Cagnazzo, Celeste, additional, Ferraris, Renato, additional, Vaira, Marco, additional, Aglietta, Massimo, additional, and Leone, Francesco, additional

Published
2019
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50. The prognostic nutritional index predicts survival and response to first‐line chemotherapy in advanced biliary cancer.

Author

Salati, Massimiliano, Filippi, Roberto, Vivaldi, Caterina, Caputo, Francesco, Leone, Francesco, Salani, Francesca, Cerma, Krisida, Aglietta, Massimo, Fornaro, Lorenzo, Sperti, Elisa, Di Maio, Massimo, Ortega, Cinzia, Fenocchio, Elisabetta, Lombardi, Pasquale, Cagnazzo, Celeste, Depetris, Ilaria, Gelsomino, Fabio, Spallanzani, Andrea, Santini, Daniele, and Silvestris, Nicola

Subjects
BILIARY tract cancer, RECEIVER operating characteristic curves, PALLIATIVE treatment, CANCER chemotherapy, CANCER
Abstract

Background: An accurate risk‐stratification is key to optimize the benefit‐to‐risk ratio of palliative treatment in advanced biliary cancer. We aimed at assessing the impact of the prognostic nutritional index (PNI) on survival and treatment response in advanced biliary cancer (ABC) receiving first‐line chemotherapy. Methods: Medical records of ABC treated with standard chemotherapy at the Modena Cancer Centre were retrospectively reviewed for variables deemed of potential interest, including the PNI. Univariate and multivariate analyses were performed to investigate the association between the covariates and overall survival (OS). Results: 114 ABC fulfilled the inclusion criteria and made up the training cohort. A PNI cut‐off value of 36.7 was established using the receiver operating characteristic (ROC) analysis. At both the univariate and the multivariate analysis, low PNI value (<36.7) was associated with shorter OS (P =.0011), together with increased NLR (P =.0046) and ECOG >1 (P <.0001). The median OS was 5.4 vs 12.1 months in the low‐ vs high PNI‐group. Moreover, a PNI value >36.7 resulted in a higher disease control in patients treated with gemcitabine/platinum combination (61.4% vs 34.3%). These results were validated in an independent cohort of 253 ABC. Conclusions: We demonstrated and externally validated a prognostic role for the PNI in ABC treated with first‐line chemotherapy. Although the PNI turned out to be predictive in the subset of patients receiving platinum/gemcitabine combination, future prospective confirmation is needed. [ABSTRACT FROM AUTHOR]

Published
2020
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