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Research on Effective Strategies After Immunotherapy for Mismatch Repair-deficient Early-stage GI Tumors

Study acronym: RESIST
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This cohort study is divided into two parts: Part A: Registry Cohort All patients with non-metastatic, MMRd/MSI-H colorectal cancers (and other gastrointestinal cancers for exploratory analysis) who have signed the general research consent will be included in a prospective registry. This includes patients who undergo primary surgical resection (+/- neoadjuvant/adjuvant therapy) or following immunotherapy, regardless of response. Part A is a multicenter observational registry with both prospective and retrospective enrolment. Prospective enrolment includes eligible patients entered into the registry after activation of the study at the respective participating site. Retrospective enrolment includes eligible patients diagnosed on or after 1 January 2024 whose clinical data were generated prior to registry activation. Both prospectively and retrospectively enrolled patients contribute to the registry analyses. Part B: Active Surveillance Cohort (Surveillance Study) A subset of patients from Part A who achieve a complete or near-complete response to ICI therapy, wish to avoid surgery, and are deemed appropriate for non-operative management by a multidisciplinary tumor board are offered inclusion in a phase II surveillance study (Part B). Patients enrolled in Part B will be analysed for the primary endpoint.
Trial Details
NCT Number NCT07829081
Lead Sponsor University Hospital, Basel, Switzerland
Conditions
(from sponsor)
Quality of Life (QOL), Mismatch Repair Deficient Colorectal Cancer, Microsatellite Instability-High Colorectal Cancer, Stage II Colorectal Cancer, Stage III Colorectal Cancer, Mismatch Repair- Deficient Rectal Cancer, Microsatellite Instability-High Rectal Cancer, Mismatch Repair-Deficient Colon Cancer +3 more
Related terms Colorectal Neoplasms, Turcot syndrome
Enrollment 234 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov