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Clinical Trials/NCT02050737
NCT02050737TerminatedNot Applicable

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

Cancer Trials Ireland14 sites in 1 country109 target enrollmentStarted: October 1, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
109
Locations
14
Primary Endpoint
Disease free survival or progression free survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

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)

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (14)

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