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The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer
Sponsor: Geneplus-Beijing Co. Ltd.
Summary
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.
Official title: A Prospective, Single Center Clinical Study on the Clinical Significance of Personalized ctDNA-MRD in Predicting the Efficacy and Monitoring the Risk of Recurrence of Cervical Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2024-12-01
Completion Date
2029-01-30
Last Updated
2024-07-18
Healthy Volunteers
No
Conditions
Locations (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China