Clinical trial · Observational
Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
NCT03821948CI-TRIAL-00046050completedClinicalTrials.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 primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).
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
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Average CRC Risk Group
- description
- Stool sample collection and blood draw in men and women aged 40 and older with average CRC risk undergoing a standard of care colonoscopy procedure
- label
- Increased CRC Risk Group
- description
- Stool sample collection and blood draw in men and women aged 40 and older with increased CRC risk undergoing a standard of care colonoscopy procedure
Primary outcomes (2)
- measure
- Stool-based biomarkers associated with genetic and epigenetic alterations
- timeFrame
- Stool sample will be collected prior to initiation of bowel preparation for colonoscopy.
- description
- The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is male or female, 40 years of age or older. * Subject is at average or increased risk for development of CRC. * Subject presents for screening or surveillance colonoscopy. * Subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy. * Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator. Exclusion Criteria: * Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years. * Subject has a diagnosis or personal history of any of the following conditions, including: 1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome). 2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"). 3. Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis. * Subject has a family history of: 1. Familial adenomatous polyposis (also referred to as "FAP"). 2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"). * Subjects with Cronkhite-Canada Syndrome. * IV contrast (e.g. CT and MRI) within 1 day \[or 24 hours\] of blood collection. * Subject has any condition that in the opinion of the Investigator should preclude participation in the study
References
Publications (0)
Data not yet available
No reference posted for this study.