Clinical trial · Observational
Colvera for Detection of Disease Recurrence
Evaluation of the Performance of the Clinical Genomics Colvera Test in the Detection of Disease Recurrence in Patients Diagnosed With Colorectal Cancer- "NOVA"
NCT03706235CI-TRIAL-00045956NOVAcompletedClinicalTrials.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)
To compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in CRC subjects who are undergoing surveillance for recurrence.
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 Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw (venipuncture) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- No recurrence
- description
- Subjects at least 30 days from end of primary treatment for colorectal cancer in a clinically indicated surveillance program (e.g. ASCO, NCCN) provide a blood sample before the next clinically indicated surveillance scan/imaging. Imaging documents no recurrence.
- interventionNames
- Other: Blood draw (venipuncture)
- label
- Recurrence
- description
- Subjects at least 30 days from end of primary treatment for colorectal cancer in a clinically indicated surveillance program (e.g. ASCO, NCCN) provide a blood sample before the next clinically indicated surveillance scan/imaging or imaging has confirmed recurrence. Imaging documents recurrence.
- interventionNames
- Other: Blood draw (venipuncture)
Primary outcomes (1)
- measure
- Sensitivity, specificity, positive predictive value and negative predictive value
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is 18 years or older, and capable and willing to provide informed consent. 2. Subject has undergone curative treatment for primary CRC of stages II and III (AJCC). 3. Subject has no clinical evidence of disease (NED) (after initial treatment) 4. Subject has concluded course of initial treatment for primary CRC (i.e. end of surgery, chemotherapy and/or radiotherapy) 5. Subject is willing/able to provide a blood sample Exclusion Criteria: 1. Subject has evidence of residual disease. 2. Subject has other organ cancer at the time of recruitment. 3. Subject has prior history of recurrent CRC. 4. Subject has concurrent serious non-neoplastic illness that makes enrollment impractical or clinically inappropriate. 5. Subject is receiving chemo- or radiotherapy at the time of blood collection, or between blood collection and radiological imaging.
References
Publications (0)
Data not yet available
No reference posted for this study.