RecruitingACTRN12612000345886

Circulating Tumour DNA as a Sensitive and Specific Marker of Response to Therapy and of Occult Disease in Colorectal Cancer

Sponsor

Ludwig Institute for Cancer Research

Enrollment

100 participants

Start Date

Jul 18, 2011

Study Type

Observational

Conditions

Patients with resectable colorectal cancer liver metastases

Summary

The purpose of this study is to measure cancer specific gene changes in the blood as a biomarker in monitoring disease status in colorectal cancer. Biomarkers are substances that can be found in blood and/or tumour tissue and may be used to measure the effects or progress of a disease or condition. Genes are substances in the body which contain information about characteristics us as individuals. Previous studies have found that the majority of colorectal cancers contain mutations in several genes (the gene is changed or different from the common form) and that these cancerrelated mutations can be detected in the blood. Identifying biomarkers are important because they may be linked with disease progression, they may help to identify people who are most likely to benefit from a certain treatment such as chemotherapy, or they may be used to track the status of cancer without the need for invasive procedures, such as biopsies.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether tiny fragments of cancer DNA in the blood (called circulating tumour DNA or ctDNA) can be used to monitor colorectal (bowel) cancer — including tracking hidden disease after surgery and measuring how well treatment is working. This blood test approach may eventually reduce the need for more invasive testing like tissue biopsies. This study focuses on patients having surgery to remove tumours or liver metastases, and those having chemotherapy. You may be eligible if: - You are 18 years of age or older - You have a confirmed diagnosis of primary colorectal cancer - Your tumour has been removed or you are scheduled for curative surgery, OR - You have liver metastases that can be surgically removed - You are fit for surgery and combination chemotherapy - You are willing to provide written consent You may NOT be eligible if: - You have had another primary cancer in the past 5 years (except minor skin cancer or cervical carcinoma in situ) - You have a medical or psychiatric condition that prevents you from following the study - You are not available for follow-up appointments Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a prospective study involving the collection of blood samples for the purposes of measuring circulating DNA from patients with resectable colorectal cancer liver metastases. Two distinct cohorts of patients, those undergoing initial liver resection followed by 12 cycles of FOLFOX and those given pre and postoperative chemotherapy will be treated and followed according to standard protocols. 60 mls of blood will be collected at specified timpoints. - 60 mls will be collected at each timepoint. COHORT 1 - Initial Surgery the timepoints are: Timepoint 1 - Screening Timepoint 2 - 4 weeks post surgery Timepoint 3 Post cycle 6 adjuvant chemotherapy (Day 1 Cycle 7) Timepoint 4 - Post cycle 12 (Days 3 at CADD disconnect) Timepoint 5 - 10 every 3 months (3 mth follow up; 6mth follow up; 12 mth follow up; 18 mth follow up and 24 mth follow up) COHORT 2 - Pre-op Chemo timpoints are: Timepoint 1 - Screening Timepoint 2 - Post cycle 1 (day 1 cycle 2) Timepoint 3 - Post cycle 2 (day 1 cycle 3) Timepoint 4 - post cycle 4 (day 1 cycle 5) Timepoint 5 - 4 weeks post surgery Timepoint 6 - Post cycle 12 (day 3 at CADD disconnect) Timepoint 7 -10 - 3 monthly follow - ups ( 3 mths; 6 mths; 9 mths; 12 mnths) Timepoint 11 & 12 - 6 monthly follow - ups (18 mths and 24 mths)

Locations(1)

Australia

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ACTRN12612000345886