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

Cancer Trials Ireland

Status: Terminated

Conditions: Colorectal Cancer

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02050737

ICORG 12-27

Details and patient eligibility

About

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

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

109 participants in 2 patient groups

A - due for adjuvant chemotherapy

Description:

Stage II/III colorectal cancer resectable disease due for adjuvant chemotherapy

B - for observation only

Description:

Stage II colorectal cancer with resectable disease for observation only