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

N/ATerminatedNCT02050737

Cancer Trials Ireland109 enrolled

Overview

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

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

109

Conditions

Colorectal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (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

Outcomes

Primary Outcomes

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

Time frame: Duration of treatment and follow up, expected to be 4 years

Secondary Outcomes

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.

Time frame: 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

Time frame: For the duration of treatment and follow up, expected to be 4 years

Data from ClinicalTrials.gov

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