Clinical Trial

Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer

Recruiting
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Record status
This record was last updated May 5, 2022 (before its estimated September 30, 2024 completion). Its status may not reflect the trial's current state.
Summary
The incidence of breast cancer in Chinese women has increased year by year, and luminal A breast cancer commonly occurs in early-stage and postmenopausal women. This type of breast cancer is not sensitive to chemotherapy, although it has a low mortality rate and distant metastasis rate. Studies have shown that luminal A breast cancer is sensitive to endocrine therapy. Patients with breast cancer who undergo excision should be followed up and their prognosis should be monitored regularly. At present, imaging detection is mainly used in the conventional follow-up of breast cancer, but the cost of many imaging examinations is high, so a cost-effective examination is urgently needed. Recent studies have found that circulating tumor cells can be used as a new type of tumor molecular marker, which can be used to diagnose tumors, judge the prognosis and monitor the efficacy by detecting the number and characteristic protein expression of circulating tumor cells. Because circulating tumor cells may develop abnormalities 4-6 months earlier than conventional imaging examination, as long as circulating tumor cells of patients are abnormal, timely PET-CT examination will neither miss diagnosis nor delay the condition. Simultaneously, the cost of hospitalization can be obviously reduced. This non-inferiority randomized controlled clinical trial is designed to compare the differences in postoperative conditions between circulating tumor cell detection and conventional imaging examination in patients with luminal A breast cancer without lymph node metastasis.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2019-08-21; most recent amendment 2022-05-03.
Status change: Not Yet Recruiting → Recruiting 2019-12-26
Trial Details
NCT Number NCT04065321
Lead Sponsor Shengjing Hospital
Conditions Breast Neoplasms
Enrollment 500 participants
Start Date 2019-10-01
Primary Completion 2024-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2022-05-05