Clinical trial · Observational
Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: "Clinical Validation of an Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C"
NCT04144751CI-TRIAL-00070021completedClinicalTrials.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 sub-study, 2019-01B, is to collect blood specimens for research use in the development and validation of a blood-based test for 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sample Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Subjects Enrolled in 2019-01 BLUE-C
- description
- Subjects will be men and women, 40 years of age or older, who enroll in Exact Sciences Protocol 2019-01 BLUE-C. Subjects will provide a blood sample at time of enrollment.
- interventionNames
- Other: Blood Sample Collection
Primary outcomes (1)
- measure
- Blood-based biomarkers associated with genetic and epigenetic alterations.
- timeFrame
- Point in time blood collection (1 day) at enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is currently enrolled in Exact Sciences Protocol 2019-01 BLUE-C. 2. Subject is willing and able to provide a blood sample. 3. Subject is willing and able to sign informed consent. Exclusion Criteria: 1\. 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.