Clinical trial · Interventional
Study of In-home Tests for Colorectal Cancer
Performance Characteristics of Immunochemical and Guaiac FOBT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to compare the performance characteristics or accuracy of different in-home screening tests for colorectal cancer (fecal occult blood tests), among patients without symptoms of colorectal cancer. Patients who meet study eligibility criteria and agree to participate in the study are asked to perform one guaiac and two immunochemical fecal occult blood tests at home prior to their colonoscopy. After the patient has completed and sent in the test kits, the patient then undergoes their previously scheduled colonoscopy. Accuracy and performance characteristics for each type of fecal occult blood test, including sensitivity, specificity, test positivity rate and positive predictive value for advanced colorectal neoplasia (advanced colorectal polyps) or colorectal cancer, will be estimated by comparing the fecal occult blood test results with the results of the colonoscopy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fecal occult blood tests | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Fecal occult blood tests
- description
- Each patient will perform one guaiac and two immunochemical fecal occult blood tests at home.
- interventionNames
- Other: fecal occult blood tests
Primary outcomes (1)
- measure
- The proportion of participants with a positive colonoscopy finding indicating an advanced colorectal neoplasia who also have a positive fecal occult blood test result
- timeFrame
- at time of colonoscopy
- description
- This outcome will assess the sensitivity of the fecal occult blood test for detection of advanced colorectal neoplasia. Advanced colorectal neoplasia will be defined as an adenoma with a diameter of 10 mm or more, a villous adenoma, a tubulovillous adenoma, an adenoma with high-grade dysplasia, carcinoma in situ, or invasive cancer. For each type of fecal occult blood test, the sensitivity for advanced colorectal neoplasia will be estimated by comparing the fecal occult blood test results with the results of the colonoscopy.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 50 - 75 years of age * Scheduled to have a colonoscopy for screening or as a routine exam * Has not had more than one episode of rectal bleeding in the last 6 months * Does not have a personal history of colorectal cancer or colorectal polyps * Has not had a positive FOBT in the 12 months prior to study enrollment * Has not had a colonoscopy within the past 5 years * Has not had a prior colon resection or colon or rectal surgery * Does not have a history of inflammatory bowel disease (e.g. ulcerative colitis or Crohn's disease) * Does not have a personal or family history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC) * Not currently taking anticoagulant medication such as Coumadin, Warfarin, Heparin, or Plavix * Able to read English
References
Publications (0)
Data not yet available