Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer
Effect of Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer Without Lymph Node Metastasis Instead of Conventional Imaging Examination After Operation: a Non-Inferiority Randomized Controlled Clinical Trial
1 other identifier
observational
500
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2019
CompletedFirst Posted
Study publicly available on registry
August 22, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2029
ExpectedMay 5, 2022
May 1, 2022
5 years
August 21, 2019
May 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
Disease-free survival refers to the period from breast cancer excision to local recurrence, distant metastasis confirmed by clinical evidence, diagnosis of the second primary tumor or death of the patient.
5 years
Secondary Outcomes (1)
Overall survival
5 years
Other Outcomes (4)
Total length of hospital stay
5 years
Average length of hospital stay per reexamination
5 years
Total cost of reexaminations
5 years
- +1 more other outcomes
Study Arms (2)
Control group
250 patients will be assigned into control group.
Trial group
250 patients will be assigned into trial group.
Interventions
All patients in the control group will undergo PET-CT examination after operation, and will reexamination once every 4 months in 2 years, every 6 months in 3-5 years, and every year in more than 5 years.
All patients in the trial group will be followed up after operation, and will reexamination once every 4 months in 2 years, every 6 months in 3-5 years, and every year in more than 5 years. Peripheral blood will be collected for detection of circulating tumor cells at each follow-up. If circulating tumor cells are abnormal (number of circulating tumor cells ≥ 2 or CD133 ≥ 1), PET-CT will be performed immediately.
Eligibility Criteria
500 patients will be recruited from outpatients and admission office of Shengjing Hospital of China Medical University by posting recruitment notice listing the study details on the bulletin board. The patients will be randomly divided into trial group and control group, with 250 patients per group.
You may qualify if:
- estrogen receptor (≥ 10%), progesterone receptor (≥ 10%) and epidermal growth factor receptor 2 negative;
- proliferation index Ki-67 \< 20%;
- no lymph node metastasis;
- systemic therapy (chemotherapy, radiotherapy and endocrine therapy) in accordance with the National Comprehensive Cancer Network guidelines;
- provision of informed consent of patients and their families.
You may not qualify if:
- Bilateral breast cancer;
- inflammatory breast cancer;
- pregnancy or lactation;
- history of other cancers or chest radiotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianyi Li, MD
Shengjing Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 21, 2019
First Posted
August 22, 2019
Study Start
October 1, 2019
Primary Completion
September 30, 2024
Study Completion (Estimated)
September 30, 2029
Last Updated
May 5, 2022
Record last verified: 2022-05