GUIDE.MRD-01-CRC: Clinical Validation and Benchmarking of Top Performing CtDNA Diagnostics - Colorectal Cancer

Launched by CLAUS LINDBJERG ANDERSEN · Oct 26, 2023

Keywords

ClinConnect Summary

The GUIDE.MRD-01-CRC clinical trial is studying a new method to help doctors determine if there is any remaining cancer in patients with colorectal cancer after surgery. This method looks for pieces of cancer DNA that can be found in the blood, which may provide valuable information on whether a patient needs more treatment. Currently, the decision-making process about additional treatments after surgery is not very effective, leading to some patients receiving too much treatment while others may not get enough.

To participate in this trial, you need to have stage III colorectal cancer and have undergone surgery to remove the tumor. You should also be eligible for follow-up chemotherapy. The study is open to adults aged 65 to 74, and it includes both men and women. If you join the trial, you can expect to provide blood samples for testing and participate in regular follow-up visits. The goal of this research is to create a reliable way to use these blood tests to tailor treatments for individual patients, ultimately improving outcomes for those with colorectal cancer.

Gender

ALL

Eligibility criteria

• • Colorectal cancer stage III
• Inclusion Criteria:
• • Colorectal cancer, UICC stage III
• • Has received curative-intent resection and is a candidate for adjuvant chemotherapy
• • Patient able to understand and sign written informed consent
• Exclusion Criteria:
• • Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome
• • Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• • Verified distant metastases
• • Not treated with adjuvant chemotherapy despite indication (incomplete treatment not included)
• • Treated with neoadjuvant chemo-radiation therapy
• • No tissue sample available for the project, or tumor content in the tissue sample is \<20%
• • Synchronous colorectal and non-colorectal cancer diagnosed per operative (except skin cancer other than melanoma)
• • Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from eligibility screening
• • Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study
• • Colorectal cancer liver metastasis
• Inclusion Criteria:
• • Colorectal cancer liver metastasis
• • Planned for curative-intent treatment
• • Performance status 0-1
• Exclusion Criteria:
• • Liver cirrhosis
• • Extrahepatic metastases
• • Other cancer within the last 5 years
• • Intervention not performed with curative intent
• • No tissue available from CRLM or primary tumor