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

Terminated

• Conditions: Colorectal Cancer

• Registration Number: NCT02050737
• Lead Sponsor: Cancer Trials Ireland

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Primary Completion: 2021-07-13
• Study Completion: 2021-07-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 109

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survival or progression free survival	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 Outcome Measures

Name	Time	Method
Accuracy, sensitivity, specificity and concordance index	Duration of treatment and follow up period, expected to be 4 years	To validate a panel of predictive and/or prognostic plasma biomarkers, proving its accuracy, sensitivity, specificity and concordance index.
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	This allows for further understanding of the role of cancer-related and/or host-related proteins in disease response and progression

Trial Locations

Locations (14)

Our Lady of Lourdes Hospital Drogheda; 🇮🇪 Drogheda, Louth, Ireland

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland

St Vincent's Hospital; 🇮🇪 Dublin, Ireland

Bon Secours Hosptial; 🇮🇪 Cork, Ireland

St James Hospital; 🇮🇪 Dublin, Ireland

Adelaide & Meath Hospital incorporating National Children's Hoptial (AMNCH); 🇮🇪 Dublin, Ireland

Beaumont Hospital; 🇮🇪 Dublin, Ireland

Galway University Hospital; 🇮🇪 Galway, Ireland

Midwestern Regional Hosptial, Limerick; 🇮🇪 Limerick, Ireland

Sligo General Hospital; 🇮🇪 Sligo, Ireland

Waterford Regional Hospital; 🇮🇪 Waterford, Ireland

Cork Universtiy Hospital; 🇮🇪 Cork, Ireland

Beacon Hospital; 🇮🇪 Bracken Rd, Sandyford Industrial Estate, Dublin 18, Ireland

Letterkenny General Hospital; 🇮🇪 Donegal, Ireland