Status:
ACTIVE_NOT_RECRUITING
IMPROVE-pT1: Accurate Allocation of Completion Resection in Early Colorectal Cancer
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Copenhagen University Hospital at Herlev
Regionshospitalet Horsens
Conditions:
Colorectal Cancer
Colorectal Polyp
Eligibility:
All Genders
18+ years
Brief Summary
After introducing a nationwide screening program for colorectal cancer (CRC) in Denmark, more cases of early-stage CRC are being detected. Cancers in the earliest stages are often removed locally, eit...
Detailed Description
KEY POINTS * 85% of patients receiving completion bowel resection after local removal of pT1 CRC are overtreated. * ctDNA is a biomarker of residual cancer disease and could help identify those patie...
Eligibility Criteria
Inclusion
- Patients having undergone local resection of pT1 colorectal cancer and with planned completion resection, as recommended by the local MDT board
- The reason for the planning of completion resection may be non-micro radical tumor removal, piece-meal resection making assessment of resection margin impossible or the presence of one or more histological risk factors
Exclusion
- Patients not able to understand information about the study and/or give informed consent
- Patients not accepting blood samples stored in biobank
- Cases with non-obtainable primary tumor tissue, required for the conduction of mutational analyses
- Other recent (within 5 years) or current malignant disease, except basocellular carcinoma of the skin
- Planned completion resection due to other factors, such as patient's wish or hereditary disposition for CRC, and with the absence of risk factors mentioned above
- Withdrawal of consent
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT06040632
Start Date
September 1 2022
End Date
July 1 2027
Last Update
April 1 2025
Active Locations (9)
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1
Bispebjerg Hospital
Copenhagen, Capital Region of Denmark, Denmark, 2400
2
Herlev Hospital
Herlev, Capital Region of Denmark, Denmark, 2730
3
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8000
4
Gødstrup Hospital
Herning, Central Jutland, Denmark, 7400