Clinical trial · Observational
Paired Analysis of Sensitivity for Colorectal Cancer Using COLVERA : PASCAL
Evaluation of the Performance and Sensitivity of the Clinical Genomics Colvera Test in Predicting Recurrence of Colorectal Cancer
NCT03706248CI-TRIAL-00043398PASCALcompletedClinicalTrials.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 subjects with colorectal cancer that have documented recurrence or no evidence of recurrence by CT.
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 Draw | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- No recurrence
- description
- CT scan has confirmed that subjects are without recurrence. Blood can be drawn up to 4 weeks after scan. Effective Feb 28, 2019, this group is closed to accrual as it has reached the goal.
- interventionNames
- Other: Blood Draw
- label
- Recurrence
- description
- CT scan has confirmed that subjects are have recurrence of their colorectal cancer. Blood can be drawn prior to any treatment for the recurrent disease.
- interventionNames
- Other: Blood Draw
Primary outcomes (1)
- measure
- Sensitivity, specificity, positive predictive value and negative predictive value
- timeFrame
- 1 year
- description
- Comparison of Colvera and CEA in recurrent and non-recurrent CRC
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 was determined to be in remission at the conclusion of primary therapy and has been in clinical surveillance for at least 6 months. (No imaging is required for the determination of remission. Last treatment was at least 6 months earlier. No requirement to complete all of the initial adjuvant treatment plan.) 4. Subject has had a surveillance CT scan within the past 4 weeks and either has recurrent CRC or does not have recurrent CRC based on that CT scan result. 5. Subject is willing to provide a blood sample. (2 PAXgene tubes) 6. Definition of recurrence is evidence of local tumor recurrence or metastasis by CT scan of chest, abdomen and pelvis or other modalities that confirm recurrent CRC Exclusion Criteria: 1. Subject has other cancer at the time of recruitment. 2. Subject has prior history of recurrent CRC. 3. Subject has a diagnosis of End Stage Renal Disease (ESRD), with or without current dialysis treatment. 4. Subject's life expectancy is less than one year based on performance status and clinical signs and symptoms. 5. Subject is receiving chemo- or radiotherapy at the time of blood collection, or between radiological imaging and blood collection. 6. Results of the recent surveillance CT of the chest, abdomen and pelvis are inconclusive regarding recurrence of CRC, and further work up (other imaging and/or biopsy) is not required at this time.
References
Publications (0)
Data not yet available
No reference posted for this study.