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

Cancer Trials Ireland14 sites in 1 country109 target enrollmentOctober 1, 2013

ConditionsColorectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Cancer Trials Ireland
Enrollment: 109
Locations: 14
Primary Endpoint: Disease free survival or progression free survival
Status: Terminated
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2013

End Date

July 13, 2021

Last Updated

9 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cancer Trials Ireland

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Disease free survival or progression free survival

Time Frame: 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 Outcomes

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.(For the duration of treatment and follow up, expected to be 4 years)