RecruitingNCT06076811

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

Danish Assessment of Minimal Residual Disease by Liquid Biopsies


Sponsor

University of Aarhus

Enrollment

1,600 participants

Start Date

Aug 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Danish study is examining liquid biopsies — blood tests that detect tumor DNA — to track minimal residual disease (tiny amounts of remaining cancer) in colon and rectal cancer patients before and after surgery. The goal is to better predict who needs additional treatment. **You may be eligible if...** - You have been diagnosed with colon or rectal cancer at clinical stage I–III - You are scheduled for surgery with the intent to cure - You are able to understand and sign written informed consent **You may NOT be eligible if...** - You have hereditary bowel cancer syndromes (such as Lynch syndrome or familial adenomatous polyposis) - Your surgery is not intended to be curative Talk to your doctor to see if this trial is 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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Locations(10)

Bispebjerg Hospital

Copenhagen, Capital Region of Denmark, Denmark

Herlev Hospital

Herlev, Capital Region of Denmark, Denmark

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Gødstrup Hospital

Herning, Central Jutland, Denmark

Regional Hospital Horsens

Horsens, Central Jutland, Denmark

Regional Hospital Randers

Randers, Central Jutland, Denmark

Regional Hospital Viborg

Viborg, Central Jutland, Denmark

Aalborg University Hospital

Aalborg, North Denmark, Denmark

Odense University Hospital

Odense, The Region of Southern Denmark, Denmark

Vejle Hospital

Vejle, Denmark

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NCT06076811


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