Actively Recruiting
Observational Clinical Study on Role of MRD in Predicting Local Therapy in Oligometastatic Breast Cancer
Led by The First Hospital of Jilin University · Updated on 2025-04-09
40
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Observational Clinical Study on Role of MRD in Predicting Local Therapy in Oligometastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed breast cancer.
- Previously confirmed metastatic breast cancer by imaging.
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2.
- Age 18 years or older at the time of signing the informed consent form.
- Willing and able to comply with the study protocol throughout the study period.
- Female subjects of childbearing potential must agree to use a highly effective method of contraception during the study.
- Voluntarily agree to and sign a written informed consent form and comply with all aspects of the trial protocol.
You will not qualify if you...
- Active or refractory infections requiring ongoing anti-infective therapy.
- Severe cardiovascular compromise such as congestive heart failure greater than NYHA class II, unstable angina, or myocardial infarction within the past 6 months, or severe arrhythmia.
- Receiving immunosuppressive therapy due to allogeneic organ transplant.
- Known to be human immunodeficiency virus (HIV) positive.
- Prior malignancy other than breast cancer, cervical cancer in situ, or non-melanoma skin cancer unless treated for at least 5 years without recurrence.
- Any medical condition that makes the subject unsuitable for the study as determined by the investigator.
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Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
Research Team
Z
Zheng Lv
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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