Colorectal Cancer
Conditions
Keywords
Curative resection, Adjuvant chemotherapy
Brief summary
This is an exploratory, translational, non-interventional and multi-centre clinical study.
Detailed description
Cohort A will consist of 100 CRAC patients with stage II/III resectable disease due for adjuvant chemotherapy. Cohort B will consist of 30 patients with stage II resectable disease for observation only. Both cohorts will have a follow up period of up to 2 years, post chemotherapy for cohort A and post resection for cohort B.
Interventions
None listed
Sponsors
Cancer Trials Ireland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival or progression free survival | Duration of treatment and follow up, expected to be 4 years | Identify plasma biomarkers with improved sensitivity to predict early recurrence of CRAC and presence of residual occult metastases following completion of adjuvant chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy, sensitivity, specificity and concordance index | Duration of treatment and follow up period, expected to be 4 years | To validate a panel of predictive and/or prognostic plasma biomarkers, proving its accuracy, sensitivity, specificity and concordance index. |
| To investigate the correlation between biomarkers identified in plasma samples with the expression of the same biomarkers at tissue level. | For the duration of treatment and follow up, expected to be 4 years | This allows for further understanding of the role of cancer-related and/or host-related proteins in disease response and progression |
Countries
Ireland
Outcome results
None listed