The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer

This study plans to enroll 80 patients with locally advanced cervical cancer (stage IB-ⅣA) confirmed by histology or cytology (according to the 2018 FIGO staging standard), who are expected to receive surgical resection or curative radiotherapy and chemotherapy. Collect baseline tumor tissue samples from patients during the treatment period, as well as peripheral blood samples (20 ml/time) from multiple treatment timepoints. Mutations in tumor tissue were detected by the 1021 genes panel, then personalized MRD monitoring probes were customized for patients, allowing for multi node peripheral blood sample ctDNA detection of enrolled patients. The clinical significance of ctDNA in prognostic stratification, recurrence monitoring, and efficacy prediction in surgical/non-surgical cervical cancer patients was explored. And compare the consistency and differences between ctDNA detection technology, imaging, and blood tumor markers in monitoring tumor disease progression, and evaluate the correlation between ctDNA status after curative treatment and patient PFS and RFS.

NCT Number	NCT06283875
Lead Sponsor	Geneplus-Beijing Co. Ltd.
Conditions	Ovarian Cancer
Enrollment	80 participants
Start Date	2024-12-01
Primary Completion	2026-01-30 (estimated)
Study Completion	2029-01-30 (estimated)
Updated on ClinicalTrials.gov	2024-07-18