Status:
ACTIVE_NOT_RECRUITING
ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial
Lead Sponsor:
Claus Lindbjerg Andersen
Collaborating Sponsors:
University of Aarhus
Conditions:
Colorectal Cancer
Colo-rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
IMPROVE-IT2 is a randomized multicenter trial comparing the outcomes of ctDNA guided post-operative surveillance and standard-of-care CT-scan surveillance. The hypothesis of this study is that ctDNA g...
Eligibility Criteria
Inclusion
- Colon or rectal cancer, tumor stage III (pT1-4N1-2,cM0) or stage II high-risk (pT4N0,cM0 and pT3N0, cM0 with risk factors)
- Have received curative intend resection and be candidates for adjuvant chemotherapy
Exclusion
- Not treated with adjuvant chemotherapy
- 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 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.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2028
Estimated Enrollment :
359 Patients enrolled
Trial Details
Trial ID
NCT04084249
Start Date
January 1 2020
End Date
June 30 2028
Last Update
July 9 2024
Active Locations (10)
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1
Herlev Hospital
Herlev, Capital Region of Denmark, Denmark, 2730
2
Gødstrup Hospital
Herning, Central Jutland, Denmark, 7400
3
Regional Hospital Horsens
Horsens, Central Jutland, Denmark, 8700
4
Regional Hospital Randers
Randers, Central Jutland, Denmark, 8930