NCT06076811 DANISH.MRD: Danish Assessment of Minimal Residual Disease by Liquid Biopsies
| NCT ID | NCT06076811 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Colorectal Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,600 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2028-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,600 participants in total. It began in 2023-08-01 with a primary completion date of 2028-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Approximately two-thirds of all colorectal cancer patients undergo surgery with the aim of curing them. However, despite the surgery, 20-25% of them experience relapse. It is possible to reduce the risk of relapse with chemotherapy, but as chemotherapy is associated with significant side effects, it is only given to patients at high risk of relapse. Currently, the risk is assessed based on an examination of the removed tumor tissue. In a previous research project, blood samples were taken after patients' surgery and examined for the presence of circulating tumor DNA (ctDNA). When cancer cells in solid tumors die, they release DNA, which can be detected in the blood. DNA in the blood has a half-life of less than 2 hours, so if ctDNA is found in a blood sample taken, e.g., 14 days after surgery, the patient most likely still has cancer cells in their body. The results show that if a patient has ctDNA in their blood after surgery, the risk of relapse is high. The presence of ctDNA in the blood has the potential to be a better indicator of the risk of future relapse than the tumor examination used today. Therefore, ctDNA analysis has the potential to become a marker that will be used in the future clinical setting for monitoring colorectal cancer. The overall objective of this study is to confirm that ctDNA found in a blood sample after intended curative treatment for CRC is a marker of residual disease and risk of recurrence and is applicable in clinical practice.
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.
Contact & Investigator
Claus L Andersen, PhD
PRINCIPAL INVESTIGATOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT06076811 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06076811 currently recruiting?
Yes, NCT06076811 is actively recruiting participants. Contact the research team at cla@clin.au.dk for enrollment information.
Where is the NCT06076811 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Herlev, Denmark, Aarhus, Denmark, Herning, Denmark and 6 additional locations.
Who is sponsoring the NCT06076811 clinical trial?
NCT06076811 is sponsored by University of Aarhus. The principal investigator is Claus L Andersen, PhD at Aarhus University Hospital. The trial plans to enroll 1,600 participants.