Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
434 participants
INTERVENTIONAL
2025-08-25
2033-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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eFTR
endoscopic full thickness resection
eFTR
endoscopic full thickness resection
Surgery
standard-of-care surgery
Surgery
standard-of-care surgery
Interventions
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eFTR
endoscopic full thickness resection
Surgery
standard-of-care surgery
Eligibility Criteria
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Inclusion Criteria
* Size ≤20 mm in diameter as deemed by the colonoscopist
* No presence of histopathological high-risk features in biopsy (high grade tumor growth, budding grade 2 or 3, or lymphovascular invasion)
* Patient eligible for surgical removal as deemed by the local MDT at the participating center
* Endoscopic images or video of the tumor
* No sign of disease beyond T2N0M0 on pre-treatment imaging, biopsy sampling, and radiographic and clinical evaluation
* No contraindication for any of the two treatment arms
* Written informed consent
* No prior or synchronous CRC
* No other malignancy which is not cured
* No more than 10 adenomas or serrated polyps
* No genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
* No inflammatory bowel disease
ALL
No
Sponsors
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Medical University of Gdansk
OTHER
Vestre Viken Hospital Trust
OTHER
Medical Biometry and Epidemiology_- Universitätsklinikum Hamburg Eppendorf
UNKNOWN
Institute of Oncology in Warsaw
UNKNOWN
Karolinska Institutet
OTHER
University Hospital, Limoges
OTHER
University Hospital, Akershus
OTHER
University of Roma La Sapienza
OTHER
Hospital Clinic of Barcelona
OTHER
Leuven University Medical Center
UNKNOWN
University Hospital, Ghent
OTHER
Sørlandet Hospital
UNKNOWN
Northern Norway Regional Health Trust
UNKNOWN
Helse Stavanger HF
OTHER_GOV
Haukeland University Hospital
OTHER
St. Olavs Hospital
OTHER
University of Oslo
OTHER
Frontier Science Foundation
UNKNOWN
Norwegian Department of Health and Social Affairs
OTHER_GOV
Responsible Party
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Michael Bretthauer
Professor
Locations
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Medical University of Gdańsk
Gdansk, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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840389
Identifier Type: -
Identifier Source: org_study_id
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