Clinical trial · Observational
Plasma-based Colorectal Cancer Screening Research & Development
Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development
NCT04027790CI-TRIAL-00049778completedClinicalTrials.gov clinicaltrialsProvenance
- 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 Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation.
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 |
|---|---|---|---|
| Colo-rectal Cancer | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epi proColon | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1 - Cancer Patients
- description
- Subjects with known colorectal cancer (i.e. AJCC/UICC stages 0, I, II, and III) who provide plasma at least 7 days after diagnosis by colonoscopy, but prior to surgery or treatment
- interventionNames
- Diagnostic Test: Epi proColon
- label
- Group 2 - Screening Subjects
- description
- Prospectively enrolled subjects reporting for screening colonoscopy who provide a blood sample up to 2 weeks prior to bowel prep and prior to colonoscopy. We accept all subjects who meet the institutional criteria as average risk subjects referred for a screening colonoscopy for colorectal cancer, including subjects undergoing a colonoscopy as a follow-up to a positive (non-colonoscopic) test
- interventionNames
- Diagnostic Test: Epi proColon
Primary outcomes (1)
- measure
- Test Positivity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 84 Years
Show eligibility criteria text
Inclusion Criteria: Group 1 * Willing and able to sign an Informed Consent and adhere to study requirements. * Subjects with colorectal cancer preferably detected by screening (any guideline recommended modality). * Colonoscopy diagnosis of colorectal cancer (CRC).\* * Blood sampling a minimum of 7 days after colonoscopy and before resection surgery. * = Strong clinical suspicion of colorectal carcinoma is also acceptable for subject enrollment; Case must have a confirmed diagnosis after surgery of CRC and be accompanied by a complete final pathology report. Inclusion Criteria: Group 2 * Willing and able to sign an Informed Consent and adhere to study requirements. * Eligible for colorectal cancer screening colonoscopy. * 45 - 84 years of age at blood sampling. * Able to provide blood sample within up to 2 weeks prior to bowel prep and colonoscopy. Exclusion Criteria: Group 1 * Subject with curative biopsy during colonoscopy. * Current neoadjuvant treatment. * Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer. * Known infection with HIV, HBV or HCV. Exclusion Criteria: Group 2 * Previous personal history of CRC, adenomatous polyps \>10mm or sessile serrated adenomas (polyps). * Familial risk for colorectal cancer (1 or more 1st degree relatives with CRC; known HNPCC or FAP). * History of inflammatory bowel disease. * Current neoadjuvant treatment. * Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer. * infection with HIV, HBV or HCV.
References
Publications (0)
Data not yet available
No reference posted for this study.