Danish Assessment of Minimal Residual Disease by Liquid Biopsies

Status: Recruiting
Location: See all (10) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

• 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).

Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Bispebjerg Hospital
RECRUITING
Copenhagen
Herlev Hospital
NOT_YET_RECRUITING
Herlev
Gødstrup Hospital
RECRUITING
Herning
Regional Hospital Horsens
RECRUITING
Horsens
Odense University Hospital
RECRUITING
Odense
Regional Hospital Randers
RECRUITING
Randers
Vejle Hospital
RECRUITING
Vejle
Regional Hospital Viborg
RECRUITING
Viborg
Contact Information
Primary
Claus L Andersen, PhD
cla@clin.au.dk
+45 7845 5319
Backup
Christina Demuth, PhD
demuth@clin.au.dk
+45 7845 5325
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2030-07-30
Participants
Target number of participants: 1600
Related Therapeutic Areas
Sponsors
Leads: University of Aarhus
Collaborators: Aarhus University Hospital

This content was sourced from clinicaltrials.gov

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