Clinical trial · Observational
CRC Detection Reliable Assessment With Blood
Prospective, Multi-center Observational Study for the Clinical Validation of the Next Generation Test for Blood-based Screening of Colorectal Cancer
NCT05551052CI-TRIAL-00090289CRC-DRAWactive not recruitingClinicalTrials.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 CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Adenomas Colon | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Disease | — | UNRESOLVED | — |
| Colonic Diseases, Functional | — | UNRESOLVED | — |
| Colon Lesion | — | UNRESOLVED | — |
| Colon Neoplasm | Colon Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colon Polyp | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Next-Gen CRC Screening Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Next-Gen CRC Screening Test
- description
- Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy
- interventionNames
- Diagnostic Test: Next-Gen CRC Screening Test
Primary outcomes (2)
- measure
- Sensitivity for CRC of the Next-Gen CRC Screening Test
- timeFrame
- blood collection up to 90 days from colonoscopy
- description
- Clinical Performance
- measure
- Specificity for CRC of the Next-Gen CRC Screening Test
- timeFrame
- blood collection up to 90 days from colonoscopy
- description
- Clinical Performance
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participant is 45 years of age or older at time of enrollment. 2. Participant is at average risk for development of colorectal cancer (as defined by inclusion and exclusion criteria) 3. Participant is able and willing to undergo a screening colonoscopy 4. Participant is able and willing to sign informed consent and adhere to study requirements 5. Participant is able to provide blood sample prior to colonoscopy (within 90 days of scheduled colonoscopy). Exclusion Criteria: 1. Previous personal history of CRC or precancerous lesions 2. Positive result from non-invasive screening test within the associated recommended intervals: 2.1 Fecal occult blood test or fecal immunochemical test within the previous 12 months 2.2 Epi proColon test within the previous 12 months 2.3 FIT-DNA (Cologuard) test within the previous 36 months 3. Diagnosed with condition associated with higher risk for colorectal cancer, such as: 3.1 Inflammatory bowel disease (IBD) 3.2 Chronic ulcerative colitis (CUC) 3.3 Crohn's disease 3.4 Familial adenomatous polyposis (FAP) 3.5 Familial history for colorectal cancer 3.5.1 One or more first-degree relatives diagnosed with CRC or adenomatous polyps before 60 years of age 3.5.2 Two or more first degree relatives diagnosed at any age with CRC 4. Individuals with relevant familial (hereditary) cancer syndrome, such as: 4.1 Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch Syndrome) 4.2 Peutz-Jeghers Syndrome 4.3 MYH-Associated Polyposis (MAP) 4.4 Gardner's syndrome 4.5Turcot's (or Crail's) syndrome 4.6 Cowden's syndrome, 4.7Juvenile Polyposis 4.8 Cronkhite-Canada syndrome 4.9 Neurofibromatosis 4.10 Familial Hyperplastic Polyposis 5. Diagnosed with chronic gastritis or cirrhosis 6. Current diagnosis of any cancer, except non-melanoma skin cancer 7. Overt rectal bleeding or bleeding hemorrhoids within previous 30 days 8. A colonoscopy within the previous 9 years, with the exception of a failed colonoscopy due to poor bowel preparation 9. Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.