Last reviewed · How we verify
NCT03264898: BestFIT
Comparative Effectiveness of FITs With Colonoscopy
trial testing Fecal immunochemical test (FIT) in Colorectal Cancer in 3,761 participants. Completed in 1 October 2023.
7 March 2023
Quick facts
| Lead sponsor | Barcey T. Levy |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 3,761 |
| Start date | 2 October 2017 |
| Primary completion | 7 March 2023 |
| Estimated completion | 1 October 2023 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Fecal immunochemical test (FIT)
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
Barcey T. Levy
Who can join
Adults 50 to 85, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Colorectal cancer is a preventable and/or a treatable cancer, but at least 43% of the United States population is not up-to-date with screening. Although 90% of colorectal cancer screening is done using colonoscopy, most other countries use fecal immunochemical tests, reserving colonoscopy for those with a positive fecal immunochemical test. This project will provide the foundation for a paradigm shift for colorectal cancer screening in the United States by identifying how well 5 different FITs work for detecting screening relevant neoplasia, thus reducing morbidity and mortality for colorectal cancer.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comparative Performance of Common Fecal Immunochemical Tests : A Cross-Sectional Study.
Levy BT, Xu Y, Daly JM, Hoffman RM, et al · · 2024 · cited 10× · PMID 39222513 · DOI 10.7326/m24-0080 -
Comparative effectiveness of five fecal immunochemical tests using colonoscopy as the gold standard: study protocol.
Levy BT, Daly JM, Xu Y, Crockett SD, et al · · 2021 · cited 8× · PMID 33974994 · DOI 10.1016/j.cct.2021.106430 -
Clock-Drawing Test as a Screening Tool for Cognitive Impairment Associated With Fecal Immunochemical Test Collection Errors.
Daly JM, Xu Y, Crockett SD, Schmidt ME, et al · · 2022 · cited 4× · PMID 36228064 · DOI 10.1370/afm.2855 -
Is Cognitive Impairment Associated with Inadequate Bowel Preparation for Colonoscopy?
Daly JM, Xu Y, Crockett SD, Hoffman RM, et al · · 2025 · cited 1× · PMID 40789626 · DOI 10.3122/jabfm.2024.240338r1 -
Accuracy of Fecal Immunochemical Tests for Detecting Advanced Colorectal Neoplasia at Surveillance Colonoscopy.
Hoffman RM, Xu Y, Crockett SD, Daly JM, et al · · 2026 · PMID 41649177 · DOI 10.14309/ctg.0000000000000997
Verify or expand the search:
- PubMed search for NCT03264898
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fecal immunochemical test (FIT)
Trials testing the same drug.
- NCT05405673 — Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia · recruiting
- NCT03597204 — Effectiveness of Fecal Immunnochemical Test and Colonoscopy Screening in Hong Kong · NA · active not recruiting
Other recruiting trials for Colorectal Cancer
Currently open trials in the same condition.
- NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
- NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
- NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03264898 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Barcey T. Levy
- Last refreshed: 2 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03264898.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing