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

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

This is an exploratory, translational, non-interventional and multi-centre clinical study.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer

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 Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Bon Secours Hosptial
  • Cork, Ireland
    • Cork Universtiy Hospital
  • Donegal, Ireland
    • Letterkenny General Hospital
  • Dublin, Ireland, 9
    • Beaumont Hospital
  • Dublin, Ireland, 7
    • Mater Misericordiae University Hospital
  • Dublin, Ireland, 8
    • St James Hospital
  • Dublin, Ireland
    • St Vincent's Hospital
  • Dublin, Ireland, 4
    • Adelaide & Meath Hospital incorporating National Children's Hoptial (AMNCH)
  • Galway, Ireland
    • Galway University Hospital
  • Limerick, Ireland
    • Midwestern Regional Hosptial, Limerick
  • Sligo, Ireland
    • Sligo General Hospital
  • Waterford, Ireland
    • Waterford Regional Hospital
  • Dublin 18
    • Bracken Rd, Sandyford Industrial Estate, Dublin 18, Ireland
      • Beacon Hospital
  • Louth
    • Drogheda, Louth, Ireland
      • Our Lady of Lourdes Hospital Drogheda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

100 CRAC patients with stage II/III resectable disease due for adjuvant chemotherapy.

30 CRAC patients with stage II resectable disease for observation only.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
A - due for adjuvant chemotherapy; Stage II/III colorectal cancer resectable disease due for adjuvant chemotherapy
B - for observation only; 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

Collaborators and Investigators

• Sponsor: Cancer Trials Ireland

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): July 13, 2021
• Study Completion (Actual): July 13, 2021

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimated): January 31, 2014

Study Record Updates

• Last Update Posted (Actual): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Adjuvant chemotherapy; Curative resection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ICORG 12-27