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1563 Background: Clinical trials that require patients to have specific actionable mutations based on next generation sequencing (NGS) present unique problems, such as recruiting patients with rare mutations, low enrollment rates, and distance between patients and trial sites. Such barriers can slow the pace of trial enrollment and delay the development of new therapeutic options. Methods: Tempus Labs has partnered with experienced research sites and pharmaceutical companies with molecularly targeted clinical trials to create the TIME Trial Network. The study portfolio includes pharmaceutical sponsored phase I-III clinical trials across solid tumors and hematological malignancies, targeting actionable mutations. This network was established to ensure rapid just-in-time (JIT) activation of trials by streamlining start-up activities (i.e., execution of CTAs and study budgets/financial exhibits, regulatory paperwork, SIV planning and conduct, drug and study supply shipments, submission to the central IRB, and sponsor-specific requirements). Rapid activation begins upon receipt of an activation form from a site partner. “Site Activated” describes a site that has fulfilled all regulatory, documentation, contracting requirements, and has sponsor approval to screen and enroll patients. Results: In Q4 2020, JIT activations were completed for 6 unique interventional clinical trials across 10 sites in 8 US states in the TIME Trial Network. On average, sites were activated in 9.4 business days. Patients enrolled had rare NGS mutations and were from geographically diverse locations. In one urgent case, trial activation, patient consent, screening, and treatment were achieved in 5 business days. In total, 91.7% of patients consented to trial. The average timeline from activation to consent was 4.5 days (range 0 - 24 days), with half of patients consenting within 1 business day. 45.5% of patients who consented to trial received the study drug within 1 day of consent; 2 patients dosed on day of consent. Conclusions: Over a 3-month period, on average, TIME Trial sites were activated in 9.4 days (compared to the 20+ week industry-wide average), and patient consent was completed in 4.5 days. Rapid JIT activations through the TIME program provide significant improvements in trial enrollment timelines and increase access to therapies nationwide. JIT activations may be especially useful for rural, underserved communities, as sites can enroll diverse patient populations and help address the equity gap in clinical trials across ethnic groups.[Table: see text]

TPS142 Background: Population-wide colorectal cancer (CRC) screening has been recommended by the United States Preventive Task Force (USPSTF) since 2008. Despite multiple CRC screening options, screening compliance rates have plateaued well below the 80% compliance goal set by leading health organizations. Almost 1 in 3 Americans are non-compliant with screening recommendations, citing reasons that screening is time consuming, unpleasant, and in the case of colonoscopy, invasive. The potential exists for a blood-based CRC screening test with high sensitivity and specificity to improve uptake and adherence to CRC screening. Methods: ECLIPSE (Evaluation of the ctDNA LUNAR-2 Test In an Average Patient Screening Episode; NCT# 04136002) is a prospective, observational, multi-center study being conducted in the United States. The primary objective is performance of a proprietary blood-based circulating tumor DNA (ctDNA) test (LUNAR-2, Guardant Health, Redwood City, CA) developed to detect CRC in a screen-relevant, average risk population as compared to colonoscopy reference. ECLIPSE involves collection of whole blood prior to a standard of care screening colonoscopy and associated preparation from 10,000 subjects. Eligibility criteria include average risk adults age 45-84 without prior history of cancer, inflammatory bowel disease, or familial predisposition to CRC, and have not received recent CRC screening. Primary outcomes are sensitivity of CRC detection and specificity of advanced neoplasia (AN) detection. Health-related outcomes at one and two-years will be collected as secondary endpoints to investigate the possibility of incidental non-CRC cases and interval CRC cases that had not reached a clinical threshold for detection at time of colonoscopy. Additional secondary objectives are positive predictive value and negative predictive value for AN detection and sensitivity of advanced adenoma detection. Enrollment began in October 2019, continues at over 130 sites nationwide, and is on track for the 24-month enrollment goal. Study enrollment remained open despite the COVID-19 pandemic. Study features including mobile phlebotomy and remote site monitoring were implemented. This contributed to successful study execution during COVID-19, as demonstrated by the enrollment rebound observed as early as June 2020 which saw higher enrollment than prior months, even pre-COVID. Clinical trial information: NCT# 04136002.

140 Background: A review of the literature failed to identify a screening tool specific to the unique needs of cancer survivors. The Coleman Supportive Oncology Collaborative (CSOC) developed a tool to evaluate psychosocial, physical and practical concerns, and emotional distress for concurrent use during the cancer survivorship visit. Based on pilot results of the tool, minor modifications were made and tested. Methods: The CSOC (v.3) survivorship tool was used in patients (n = 49) who had completed their adjuvant therapy at one of two safety net hospitals in Chicago, IL. The CSOC v.3 screening tool items (n = 44) include: PHQ4, fear of another cancer or recurrence, financial, social and religious concerns, nutritional concerns, physical concerns, lifestyle risk factors, and treatment/care concerns. Results: The most common patient concerns included: fear of another cancer 53% (26/49), tingling in my hands/feet 53% (26/49), concerns about diet 51% (25/49), pain 51% (25/49), sleep 51% (25/49), dry skin 47% (23/49); endorsement of these concerns were not significantly associated. Of the 44 items, 16 were reported by at least 30% of patients, and 3 items were reported by less than 10% of patients. There was an average of 15 items/concerns noted by patients with a maximum of 27 items and a minimum of 5 items. Clinicians (n = 7) reported the use of the screening tool results aided the survivorship appointment discussion, directing the focus to reported patient’s concerns. Conclusions: Survivors continue to experience multiple concerns and distress, thus they may benefit from a comprehensive tool that is tailored to capture their unique survivorship needs. Administration of the tool at the beginning of the survivorship appointment provided the framework for the patient’s appointment narrative. An additional study is planned to compare use of the tool versus current practice at a large academic center.

8 Background: Screening mammography (SM) is a routinely used modality for earlier detection of breast cancer and is effective in reducing breast cancer-related morbidity and mortality. A better understanding of the impact of access to primary care physician (PCP), on the screening protocols and stage presentation, is needed to address the issue of breast cancer stage disparity amongst underserved women. Methods: A retrospective chart review of the electronic medical record, for breast cancer patients newly diagnosed from 2012-2013, was performed using the tumor registry at Bellevue Hospital Center, the largest public hospital in New York City. Patients with recurrent breast cancer, stage IV breast cancer, and those that weren’t managed surgically at our institution, were excluded from the study. Data including patient demographics, established relationship with PCP, and screening mammogram and palpable mass at presentation, were obtained and analyzed using SPSS Statistics Software. Results: 173 patients were included in the study of which 5 presented with bilateral breast cancer (n = 178). The majority of the patients seen at our institution were from minority groups, primarily Hispanic (34%) and Chinese (23%). 129 patients (72%) had a PCP at the time of diagnosis versus 49 patients (28%) without a PCP. Patients without a PCP were more likely to have a palpable breast mass at presentation, compared to patients with a PCP (73% vs. 42% respectively, p < 0.05). Furthermore, only 32 % of patients without a PCP had a SM at time of presentation, compared to 61% of patients with a PCP (p = 0.003). Overall, in the group of patients with a PCP, the majority presented with stage I breast cancer (43%), followed by 29% with stage 0. In comparison, the majority of patient without a PCP presented with stage II (41%), followed by 29% with stage I (p = 0.019). Conclusions: There is a benefit for patients with access to a PCP, as it leads to a higher likelihood of breast cancer detection via SM, as opposed to a symptomatic presentation, such as a palpable mass. Therefore, these patients are more likely to be diagnosed with an earlier stage of breast cancer, which improves their mortality.

e16001 Background: Although TPF is the standard induction regimen for USCCHN, frequent comorbidities in USCCHN pts limit its use. TPF may improve cure rate providing better patient screening. Study...