Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
SUSPENDED
NCT05867901

A Prospective Study on Predicting Recurrence Risk of Postoperative High-risk GISTs in NED State Based on MRD Detection Via Liquid Biopsy

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

The goal of this single-center, prospective, observational cohort study is to learn whether tumor-informed minimal residual disease (MRD) testing in blood can predict recurrence in 66 patients with high-risk gastrointestinal stromal tumor (GIST) who are not currently receiving postoperative adjuvant therapy. The main questions it aims to answer are: Can changes in MRD during follow-up predict tumor recurrence? How closely do MRD results agree with contrast-enhanced computed tomography (CT) findings, and can MRD identify recurrence earlier than CT? Can tumor genomic features, changes in MRD, and clinicopathological features be combined to develop a model for predicting recurrence risk? Participants will have their surgical tumor tissue analyzed, provide blood samples for MRD testing, and undergo regular clinical follow-up and contrast-enhanced CT examinations for 3 years. Participants may choose to receive and discuss their MRD results. This study will not assign or change treatment based on MRD results. Recurrence and treatment decisions will remain based on routine clinical assessment, primarily contrast-enhanced CT and multidisciplinary review.

Official title: A Prospective Study on Predicting Recurrence Risk of Postoperative High-risk Gastrointestinal Stromal Tumors in NED State Based on Minimal Residual Disease Detection Via Liquid Biopsy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

66

Start Date

2023-06-01

Completion Date

2028-12-31

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Tumor-Informed ctDNA-Based MRD Testing

Patient-specific variants will be selected from tumor tissue sequencing and used for serial ctDNA-based MRD testing of peripheral blood samples during follow-up. MRD results are investigational and will not independently guide treatment decisions.

DIAGNOSTIC_TEST

Contrast-Enhanced CT

Contrast-enhanced CT will be performed before enrollment to confirm no evidence of disease and every 3 months during 3 years of follow-up. MRI or PET-CT may be used when needed. Imaging-confirmed recurrence will be reviewed by a multidisciplinary team.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China