Circulating Tumour DNA as a Marker of Occult Disease in Stage II Colorectal Cancer and Response to Therapy in Metastatic Colorectal Cancer

Not Applicable

Recruiting

• Conditions: Measuring cancer specific gene changes in the blood as a biomarker in monitoring disease status in stage II and IV colorectal cancer.; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12612000326897
• Lead Sponsor: udwig Institute for Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Patients with histologically confirmed primary colorectal cancer
For the stage II colon cancer (cohort A)
-Patients with curatively resected stage II primary colon cancer
-Patients must be registered for study within 10 weeks of surgery
For the metastastic (stage IV) colorectal cancer (cohort B)
-Patients with measurable disease by RECIST criteria version 1.1
-Patients fit to receive standard first line combination chemotherapy, with cytotoxic agents and any biological therapy given at standard doses.
ECOG performance status 0 - 2
Patients willing to provide written informed consent

Exclusion Criteria

1. History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix.
2. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol.
3. Patients with major organ impairment.
4. Patients that are not accessible for follow-up.

Study & Design

• Study Type: Observational
• Study Design: Not specified