An observational study in Colorectal Cancer, Diagnosis and Advanced Colorectal Neoplasia, sponsored by University of California, San Diego. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of California, San Diego · Observational
This pilot study will assess whether a larger study of stool testing for colorectal cancer is practical. It plans to enroll 40 adults born in 1960 or later who have new symptoms that could be related to colorectal cancer. Participants will collect a stool sample at home using a fecal immunochemical test (FIT), complete a questionnaire, and undergo blood tests and colonoscopy as part of their usual medical care. Researchers will compare research FIT results with colonoscopy findings and assess recruitment, sample collection, and completion of study activities. Research FIT results will not routinely be shared with participants or their clinicians. If a research FIT result is abnormal and colonoscopy has not been completed within six months, the study team will notify the primary care provider to encourage colonoscopy follow-up.
This prospective pilot cohort study will evaluate the feasibility of implementing a symptomatic FIT research strategy in the UC San Diego Health system. Recruitment will use electronic health record screening and clinician and patient outreach. Consented participants will provide an at-home stool specimen for research FIT testing and questionnaire data. Usual-care complete blood count, ferritin, and colonoscopy findings will be collected. Feasibility assessments include recruitment, enrollment, stool specimen return, and completion of study activities. Preliminary FIT performance will be assessed against adequate-quality usual-care colonoscopy completed within six months of FIT.
A transition from UCSD laboratory FIT testing to quantitative research FIT testing performed by Polymedco is planned, conditional on IRB approval and execution of the required institutional agreement. Participants using the quantitative FIT kit will mail specimens directly to Polymedco. Specimens and results will be coded by study ID, and the linkage key will remain at UCSD without Polymedco access. The study is supported by a gift from Curebound.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 40 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
UC San Diego Health primary care patients born in 1960 or later with newly identified signs or symptoms potentially consistent with colorectal cancer. Potential participants will be identified through electronic health record screening and clinician or patient outreach.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adults 18 years or older, born in 1960 or later, with newly identified signs or symptoms potentially consistent with colorectal cancer. Participants provide an at-home stool specimen for research FIT testing and complete a questionnaire. Usual-care blood test and colonoscopy findings are collected for comparison.
Diagnostic Test: Quantitative fecal immunochemical test
All enrolled subjects will complete a quantitative immunochemical test and reference colonoscopy
Enrollment rate
Percentage of eligible patients approached who provide informed consent and enroll in the study. Calculated as the number enrolled divided by the number of eligible patients approached, multiplied by 100.
Time frame: From recruitment opening through the end of recruitment, up to 12 months
Stool sample return rate
Percentage of enrolled participants who return a stool specimen for research fecal immunochemical testing. Calculated as the number returning a specimen divided by the number enrolled, multiplied by 100.
Time frame: From enrollment through completion of participant follow-up, up to 6 months
Completion of study activities
Percentage of enrolled participants completing each planned activity: research stool specimen collection, study questionnaire, usual-care blood testing, and usual-care colonoscopy. Completion percentages will be reported separately for each activity, using all enrolled participants as the denominator.
Time frame: From enrollment through completion of participant follow-up, up to 6 months
Advanced neoplasia
Proportion of patients with advanced neoplasia (advanced adenoma, advanced serrated polyp, or colorectal cancer) at time of colonoscopy.
Time frame: At time of colonoscopy completed within 6 months of FIT.
Sensitivity for advanced neoplasia
Proportion of people with advanced neoplasia who have an abnormal FIT (defined at a 4 nanogram/g feces cutoff) . Denominator = # of people with advanced neoplasia; Numerator = # of people with an abnormal FIT
Time frame: At time of colonoscopy completed within 6 months of FIT.
Specificity for advanced neoplasia
Proportion of people without advanced neoplasia who have normal FIT (defined at below a 4 nanogram/g feces cutoff) . Denominator = # of people without advanced neoplasia; Numerator = # of people with a normal FIT
Time frame: At time of colonoscopy completed within 6 months of FIT.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.
Of 528 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's planned 11 months is below that.
Counting every sponsor, half of 645 studies reached it within 51 months; a quarter within 27 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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University of California, San Diego →