Clinical trial · Observational
Plasma Biomarkers C-RAC, ICORG 12-27, V1
Identification of Plasma Biomarkers in Early Detection of Colorectal Adenocarcinoma Recurrence (C-RAC Plasma Biomarker Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.
Summary
Brief summary (as posted)
This is an exploratory, translational, non-interventional and multi-centre clinical study.
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
Design
Arms and outcomes
Arms (2)
- label
- A - due for adjuvant chemotherapy
- description
- Stage II/III colorectal cancer resectable disease due for adjuvant chemotherapy
- label
- B - for observation only
- description
- Stage II colorectal cancer with resectable disease for observation only
Primary outcomes (1)
- measure
- Disease free survival or progression free survival
- timeFrame
- Duration of treatment and follow up, expected to be 4 years
- description
- Identify plasma biomarkers with improved sensitivity to predict early recurrence of CRAC and presence of residual occult metastases following completion of adjuvant chemotherapy
Secondary outcomes (2)
- measure
- Accuracy, sensitivity, specificity and concordance index
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must be able to give written informed consent * Histologically or cytologically confirmed CRAC * Cohort A: colorectal cancer patients with stage II/III resectable disease due for adjuvant chemotherapy OR Cohort B: colorectal cancer patients with stage II resectable disease for observation only * Age ≥ 18 years * Treatment with curative intent * Eastern Cooperative Oncology Group (ECOG) Performance status 0 - 2 Exclusion Criteria: * Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient when participating in this trial * Evidence of a metastatic disease
References
Publications (0)
Data not yet available