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RECRUITING
NCT06918262

Observational Clinical Study on Role of MRD in Predicting Local Therapy in Oligometastatic Breast Cancer

Sponsor: The First Hospital of Jilin University

View on ClinicalTrials.gov

Summary

This is an observational clinical study of MRD as a predictor of local treatment in patients with oligometastatic breast cancer. The aim of the study is to assess the correlation between MRD levels and prognosis in patients with oligometastatic breast cancer who have undergone local treatment in order to identify the population that would benefit from local treatment and to develop an individualised treatment plan. Subjects will agree to participate in this study and will be asked to collect as much medical history and demographic information as possible prior to enrolment to confirm that they meet the inclusion/exclusion criteria, and that they will undergo imaging and MRD testing prior to their first study treatment. Furthermore, subjects will undergo tumour imaging and MRD testing every 3 months (±7 days) after MRD treatment for the duration of the study, with additional investigations or more frequent tumour imaging evaluations as clinically indicated during the study.

Official title: An Observational Clinical Study to Evaluate the Role of MRD in the Prediction of Local Therapy in Patients With Oligometastatic Breast Cancer.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2024-01-01

Completion Date

2027-10-31

Last Updated

2025-04-09

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

local treatment

Tumour somatic mutations were identified by 1021 panel sequencing of tumour tissues from cancer patients, and up to 20 mutations were selected as follow-up monitoring loci based on the tumour somatic variants of the patients, and a personalised panel was designed and customised.Post-operative blood from patients was analysed for recurrence risk stratification and drug indications using a combination of personalised panel and a cancer-specific core panel (\~5 kb) stacked on top of each other. The postoperative blood of patients was subjected to cfDNA targeted capture and ultra-high depth NGS sequencing (\>100,000×) to analyse the status of the surveillance loci in the peripheral blood for recurrence risk stratification and medication advice.

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China