Clinical trial · Observational
Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance
Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance (PROVE)
- 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)
This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pr e- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Arm A
- description
- Patients newly diagnosed with CRC who have not yet had treatment or surgery.
- label
- Arm B
- description
- People at average risk of CRC undergoing screening for colorectal cancer with colonoscopy.
Primary outcomes (1)
- measure
- Development of assay
- timeFrame
- Baseline
- description
- The primary objective of this study is to optimize and evaluate the performance, including sensitivity and specificity, of the preliminary cfDNA marker panel to detect CRC and APL.
Secondary outcomes (1)
- measure
- ML Training
- timeFrame
- Through study completion to extend up to 24 months post LPI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 84 Years
Show eligibility criteria text
Inclusion Criteria: * Arm A: Diagnosed with CRC * Arm B: Undergoing screening with colonoscopy for CRC Exclusion Criteria: * Arm A: Undergoing treatment for CRC, * Arm B: Past history of CRC
References
Publications (0)
Data not yet available