RecruitingNCT06918262

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

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


Sponsor

The First Hospital of Jilin University

Enrollment

40 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This observational study is examining whether a blood-based test for minimal residual disease (MRD) — which detects tiny amounts of remaining cancer in the bloodstream — can help predict who with oligometastatic breast cancer (cancer that has spread to only a few sites) might benefit from local treatments like radiation or surgery to those sites. **You may be eligible if...** - You are 18 or older - You have been diagnosed with breast cancer that has spread to other parts of your body (metastatic breast cancer), confirmed by prior imaging - Your general health is good (ECOG 0-2) - You are willing to comply with the study protocol **You may NOT be eligible if...** - You have an active serious infection requiring ongoing treatment - You have severe heart problems, including unstable angina or recent heart attack - You have had an organ transplant requiring immunosuppressive therapy - You are HIV positive Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTlocal 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

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NCT06918262


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