DANISH.MRD: Danish Assessment of Minimal Residual Disease by Liquid Biopsies

Launched by UNIVERSITY OF AARHUS · Oct 4, 2023

Keywords

ClinConnect Summary

The DANISH.MRD clinical trial is studying a new way to check for leftover cancer after surgery in patients with colorectal cancer. Even after surgery, some patients may still have cancer cells in their bodies, which can lead to a relapse. This trial is looking at whether testing for circulating tumor DNA (ctDNA) in the blood can help identify patients at higher risk of relapse more accurately than the current method, which involves examining the removed tumor tissue. If ctDNA is found in the blood after surgery, it suggests that the patient may still have cancer, indicating a need for closer monitoring or additional treatment.

To participate in this trial, patients should have been diagnosed with colorectal cancer (stages I-III) and be scheduled for surgery aimed at curing the disease. They should be able to understand and sign consent forms. Those with certain conditions, like hereditary colorectal cancer or inflammatory bowel disease, cannot participate. Participants will be monitored to see how well ctDNA testing works in predicting relapse risk. Overall, this trial aims to improve how doctors assess the risk of cancer returning and tailor treatments for patients after surgery.

Gender

ALL

Eligibility criteria

• • DANISH.MRD part I - Surgery
• Inclusion Criteria:
• • Colon or rectal cancer, clinical tumor stage I-III.
• • Patient able to understand and sign written informed consent.
• • Scheduled for curative-intent resectional surgery (including "compromised" curative resections).
• 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.
• • Malignant colorectal polyps diagnosed after polypectomy.
• • 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.
• • DANISH.MRD part II - Surveillance
• Inclusion Criteria:
• • Participation in DANISH.MRD part I - Surgery.
• • Colorectal cancer, UICC stage III.
• • Has received curative-intent resection and is a candidate for adjuvant chemotherapy (3- or 6-months regime).
• Exclusion Criteria:
• • Not treated with adjuvant chemotherapy
• • Treated with neoadjuvant chemo-radiation therapy.
• • 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.