Last updated: February 27, 2024
Sponsor: Leiden University Medical Center
Overall Status: Active - Recruiting
Phase
2
Condition
Rectal Cancer
Colon Cancer
Colon Cancer; Rectal Cancer
Treatment
SGM-101
Clinical Study ID
NCT06280690
NL83765.058.23
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient must have suspected T1RC/HGD and scheduled for a local endoscopic en-blocresection. The rectum is defined as the area between the linea dentata and 10cm abano.
- Age > 18 years old
- Patients should be capable and willing to give signed informed consent before studyspecific procedures.
Exclusion
Exclusion Criteria:
- Prior participation in this study
- Previous administration of SGM-101
- Patients with a history of anaphylactic shock
- Patients pregnant or breastfeeding, lack of effective contraception in male or femalepatients with reproductive potential
- Any condition that the investigator considers to be potentially jeopardizing thepatients' well-being or the study objectives.
Study Design
Total Participants: 20
Treatment Group(s): 1
Primary Treatment: SGM-101
Phase: 2
Study Start date:
January 31, 2024
Estimated Completion Date:
July 30, 2025
Study Description
Connect with a study center
Leiden University Medical Center
Leiden, 2333ZA
NetherlandsActive - Recruiting
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