Study Stopped
As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.
Plasma Biomarkers C-RAC, ICORG 12-27, V1
Identification of Plasma Biomarkers in Early Detection of Colorectal Adenocarcinoma Recurrence (C-RAC Plasma Biomarker Study)
1 other identifier
observational
109
1 country
14
Brief Summary
This is an exploratory, translational, non-interventional and multi-centre clinical study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2013
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 23, 2014
CompletedFirst Posted
Study publicly available on registry
January 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2021
CompletedJuly 8, 2025
July 1, 2025
7.8 years
January 23, 2014
July 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
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
Eligibility Criteria
100 CRAC patients with stage II/III resectable disease due for adjuvant chemotherapy. 30 CRAC patients with stage II resectable disease for observation only.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Beacon Hospital
Bracken Rd, Sandyford Industrial Estate, Dublin 18, Ireland
Our Lady of Lourdes Hospital Drogheda
Drogheda, Louth, Ireland
Bon Secours Hosptial
Cork, Ireland
Cork Universtiy Hospital
Cork, Ireland
Letterkenny General Hospital
Donegal, Ireland
Adelaide & Meath Hospital incorporating National Children's Hoptial (AMNCH)
Dublin, 4, Ireland
Mater Misericordiae University Hospital
Dublin, 7, Ireland
St James Hospital
Dublin, 8, Ireland
Beaumont Hospital
Dublin, 9, Ireland
St Vincent's Hospital
Dublin, Ireland
Galway University Hospital
Galway, Ireland
Midwestern Regional Hosptial, Limerick
Limerick, Ireland
Sligo General Hospital
Sligo, Ireland
Waterford Regional Hospital
Waterford, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2014
First Posted
January 31, 2014
Study Start
October 1, 2013
Primary Completion
July 13, 2021
Study Completion
July 13, 2021
Last Updated
July 8, 2025
Record last verified: 2025-07