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Symptomatic FIT for Colon Cancer Detection, a Pilot Study

4 november 2026 uppdaterad av: Samir Gupta, University of California, San Diego

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

40

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Samir Gupta, MD, MSCS, AGAF
  • Telefonnummer: 858-822-4499
  • E-post: s1gupta@ucsd.edu

Studieorter

  • Förenta staterna
    • California
      • La Jolla, California, Förenta staterna, 92037
        • Moores Cancer Center, University of California, San Diego

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

Inclusion Criteria:

  • Adults 18 years or older, born in 1960 or later.
  • Newly reported signs or symptoms potentially consistent with colorectal cancer: hematochezia, persistent abdominal pain, altered bowel habits (constipation, diarrhea, or narrow stools), unintentional weight loss greater than 5 pounds, or iron deficiency anemia. Symptoms must not have been reported to the primary care provider before the index visit.

Exclusion Criteria:

  • Acute symptoms within 14 days requiring urgent evaluation.
  • Up-to-date colorectal cancer screening: colonoscopy within 10 years, sigmoidoscopy within 5 years, FIT within 1 year, or multitarget stool DNA/RNA or cell-free DNA testing within 3 years.
  • Prior colorectal cancer, colorectal resection, hereditary colorectal cancer syndrome (including Lynch syndrome or familial adenomatous polyposis), or inflammatory bowel disease.
  • Documented infectious cause that clinically explains the symptoms. A negative infectious workup or absence of an infectious workup does not exclude participation.
  • Pregnancy.
  • Lack of health insurance for usual-care procedures.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Adults with new colorectal cancer-related signs or symptoms

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.
Diagnostiskt test: Quantitative fecal immunochemical test

All enrolled subjects will complete a quantitative immunochemical test and reference colonoscopy

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Enrollment rate
Tidsram: From recruitment opening through the end of recruitment, up to 12 months

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.
From recruitment opening through the end of recruitment, up to 12 months
Stool sample return rate
Tidsram: From enrollment through completion of participant follow-up, up to 6 months

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.
From enrollment through completion of participant follow-up, up to 6 months
Completion of study activities
Tidsram: From enrollment through completion of participant follow-up, up to 6 months

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.
From enrollment through completion of participant follow-up, up to 6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Advanced neoplasia
Tidsram: At time of colonoscopy completed within 6 months of FIT.

Proportion of patients with advanced neoplasia (advanced adenoma, advanced serrated polyp, or colorectal cancer) at time of colonoscopy.
At time of colonoscopy completed within 6 months of FIT.
Sensitivity for advanced neoplasia
Tidsram: At time of colonoscopy completed within 6 months of FIT.

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
At time of colonoscopy completed within 6 months of FIT.
Specificity for advanced neoplasia
Tidsram: At time of colonoscopy completed within 6 months of FIT.

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
At time of colonoscopy completed within 6 months of FIT.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of California, San Diego

Samarbetspartners

CUREBOUND, INC.

Utredare

  • Huvudutredare: Samir Gupta, MD, MSCS, AGAF, University of California, San Diego

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

2 november 2026

Primärt slutförande (Beräknad)

31 oktober 2027

Avslutad studie (Beräknad)

31 oktober 2027

Studieregistreringsdatum

Först inskickad

4 november 2026

Först inskickad som uppfyllde QC-kriterierna

4 november 2026

Första postat (Faktisk)

10 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 814209

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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