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Multimodal hyperspectroscopy as a triage test for cervical neoplasia: Pivotal clinical trial results
- Source :
- Gynecologic Oncology. 130:147-151
- Publication Year :
- 2013
- Publisher :
- Elsevier BV, 2013.
-
Abstract
- Objective To prospectively evaluate a new non invasive device that combines fluorescence and reflectance spectroscopy in a population in women at risk for cervical dysplasia. Methods A total of 1607 women were evaluated with multimodal hyperspectroscopy (MHS), a painless test with extremely high spectral resolution. Subjects who were referred to colposcopy based on abnormal screening tests or other referral criteria underwent the MHS test and also had a sample taken for additional cytology and presence of high risk human papilloma virus (HPV) prior to undergoing biopsy. Results Sensitivity of MHS for cervical intraepithelial neoplasia (CIN) 2+ was 91.3% (252/276). Specificity, or the potential reduction in referrals to colposcopy and biopsy, was 38.9% (222/570) for women with normal or benign histology and 30.3% (182/601) for women with CIN1 histology. Two year follow-up data, collected for a subgroup of 804 women, revealed 67 interval CIN2+ that originally were diagnosed at enrollment as normal or CIN1. MHS identified 60 of these (89.6%) as positive for CIN2+ prior to their discovery during the two year follow-up period. Conclusions MHS provides an immediate result at the point of care. Recently, the limitations of cytology have become more obvious and as a consequence greater emphasis is being placed on HPV testing for cervical cancer screening, creating a need for an inexpensive, convenient and accurate test to reduce false positive referrals to colposcopy and increase the yield of CIN2+ at biopsy. MHS appears to have many of the attributes necessary for such an application.
- Subjects :
- Adult
Optics and Photonics
medicine.medical_specialty
Adolescent
Population
Uterine Cervical Neoplasms
Cervical intraepithelial neoplasia
Young Adult
Cytology
Biopsy
medicine
Humans
Prospective Studies
education
Papillomaviridae
Early Detection of Cancer
Gynecology
Colposcopy
education.field_of_study
medicine.diagnostic_test
business.industry
Obstetrics
Spectrum Analysis
Papillomavirus Infections
Obstetrics and Gynecology
Uterine Cervical Dysplasia
medicine.disease
Triage
Clinical trial
Spectrometry, Fluorescence
Oncology
Dysplasia
Female
business
Subjects
Details
- ISSN :
- 00908258
- Volume :
- 130
- Database :
- OpenAIRE
- Journal :
- Gynecologic Oncology
- Accession number :
- edsair.doi.dedup.....89398587efe2a74e3730ba93458475d8
- Full Text :
- https://doi.org/10.1016/j.ygyno.2013.04.012