Clinical trial · Observational
Validation of Colon Biomarkers for the Early Detection of Colorectal Adenocarcinoma
Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma
- 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 investigators are undertaking a multi-center, 13000 subject validation study of several biomarkers for early detection of colon cancer. There are stool based biomarkers and blood based biomarkers being validated in this study. The biomarkers will be compared with colonoscopy and with FIT (fecal immunohistochemistry) tests which are the current standards for colon cancer screening. This is an NCI-early Detection Research Network funded project. The population targeted for this study are those persons undergoing colonoscopy for screening. Prior to colonoscopy or even prepping for colonoscopy, subjects will provide blood and stool samples as well as specific data regarding their GI and general medical history and concomitant medications. If subjects are interested in participating, arrangements will be made to see them. The informed consent process will take place, blood will be obtained, data will be obtained, and the stool kit described and given to the subject to take home. Stool samples will be sent back to the University of Michigan using prepaid mailing labels.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Measure the sensitivity of a blood based panel of biomarkers relative to fecal immunochemical testing
- timeFrame
- 12 weeks from enrollment to completion of colonoscopy
- description
- Test the hypothesis that sensitivity of stool vimentin methylation and/ the blood based panel (serum galectin-3 ligand, CEA, methylated genes BCAT1/IKZF1, Hypomethylated LINE1 from circulating cell free DNA) when combined with fecal immunochemical testing (FIT) will significantly improve the sensitivity of FIT for the detection of colorectal adenocarcinoma, and maintain specificity greater than 0.80.
Secondary outcomes (2)
- measure
- To measure the specificity of a blood based panel of biomarkers relative to fecal immunochemical testing
- timeFrame
- 12 weeks from enrollment to completion of colonoscopy
- description
- To test the hypothesis that blood based panel (for example, serum galectin-3 ligand, CEA, methylated genes BCAT1/IKZF1, Hypomethylated LINE1 from circulating cell free DNA), at the same sensitivity of that for fecal immunochemical testing (FIT) for the detection of colorectal adenocarcinoma, has a specificity greater than 0.55 with an anticipated specificity ≥ 0.70.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Adults 40\*+ undergoing a first time colonoscopy for screening OR * Positive guaiac-based occult blood or fecal immunochemical test (e.g. FOBT, FIT) in the past 12 months (365 days) * Willing to sign informed consent * Able to physically tolerate removal of 50 ml of blood * Willing to collect 2 stool samples (\*age 60 and up in U.S., 50 and up outside US) Exclusion Criteria: * Inability to provide informed consent * History of Inflammatory Bowel Disease * Overt rectal bleeding within 1 month (30 days) (including due to suspected hemorrhoids) * Undergone resection of the colon for any indication * Subjects with known HIV or chronic viral hepatitis (Hepatitis B and C) * Subjects with known or suspected HNPCC (Lynch Syndrome) or FAP * Any cancer within 5 years of enrollment except any of the following: * Squamous cell carcinoma of the skin or Basal cell carcinoma of the skin * Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery only. (Excluded if had pelvic radiation) * Stage , 0, I or Ia Grade 1 adenocarcinoma of the endometrium treated with surgery
References
Publications (0)
Data not yet available