Plasma Biomarkers C-RAC, ICORG 12-27, V1

Study Overview
=================
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.

Official Title
-----------------
Identification of Plasma Biomarkers in Early Detection of Colorectal Adenocarcinoma Recurrence (C-RAC Plasma Biomarker Study)

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A - due for adjuvant chemotherapy<br>Stage II/III colorectal cancer resectable disease due for adjuvant chemotherapy | |
| B - for observation only<br>Stage II colorectal cancer with resectable disease for observation only | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival or progression free survival | Identify plasma biomarkers with improved sensitivity to predict early recurrence of CRAC and presence of residual occult metastases following completion of adjuvant chemotherapy | Duration of treatment and follow up, expected to be 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy, sensitivity, specificity and concordance index | To validate a panel of predictive and/or prognostic plasma biomarkers, proving its accuracy, sensitivity, specificity and concordance index. | Duration of treatment and follow up period, expected to be 4 years | 
| To investigate the correlation between biomarkers identified in plasma samples with the expression of the same biomarkers at tissue level. | This allows for further understanding of the role of cancer-related and/or host-related proteins in disease response and progression | For the duration of treatment and follow up, expected to be 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Curative resection, Adjuvant chemotherapy