Actively Recruiting

Age: 18Years - 60Years
FEMALE
NCT04065321

Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer

Led by Shengjing Hospital · Updated on 2022-05-05

500

Participants Needed

2

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Circulating Tumor Cell Detection in Patients With Luminal A Breast Cancer

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Estrogen receptor 10% or higher, progesterone receptor 10% or higher, and epidermal growth factor receptor 2 negative
  • Proliferation index Ki-67 less than 20%
  • No lymph node metastasis
  • Receiving systemic therapy including chemotherapy, radiotherapy, and endocrine therapy according to guidelines
  • Provided informed consent for participation
Not Eligible

You will not qualify if you...

  • Bilateral breast cancer
  • Inflammatory breast cancer
  • Pregnancy or lactation
  • History of other cancers or chest radiotherapy

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China, 110004

Actively Recruiting

2

Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China, 110042

Actively Recruiting

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Research Team

J

Jianyi Li

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

2

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