RecruitingNCT05326295

Evaluation of Treatment Efficacy by Circulating Tumor Cell Phenotype Surveillance in Breast Cancer Patients

Surveillance of Circulating Tumor Cell Phenotype in Early Stage Breast Cancer Patients With Neoadjuvant Chemotherapy or Adjuvant Chemotherapy

Sponsor

Hunan Cancer Hospital

Enrollment

1,000 participants

Start Date

Mar 1, 2019

Study Type

OBSERVATIONAL

Conditions

Breast Neoplasms Chemotherapy Effect Neoplastic Cells, Circulating

Summary

The phenotype of circulating tumor cells (CTCs) is supposed to be significant indicator that is correlated the prognosis of breast cancer patients who have completed neoadjuvant chemotherapy, primary tumor surgery with/without adjuvant chemotherapy. The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the prognosis of breast cancer patients.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

The age is more than 18 years old;
Pathology confirmed malignant breast tumor;
No clinical diagnosis of other malignancies, unstable complications or uncontrolled infection;
Life expectancy is greater than 6 month;
The main organ function is normal;
The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance.

Exclusion Criteria6

Patients who had suffered from other malignant tumors;
With uncontrolled bacterial, viral or fungal infections;
With physical or mental disorders
Without or limited civil capacity;
Infected with human immunodeficiency virus (HIV)；
Circumstances in which the investigator considers it inappropriate to participate in this study.

Interventions

DIAGNOSTIC_TESTCTC detection

CTCs separation and enrichment technology. Combined with the prognosis of patients with recurrence and survival time, we explored the evaluation of CTC number, cell phenotype distribution, PDL1 and FOXC2 expression on the prognosis of early stage breast cancer patients. The research results are expected to provide a new effective index and theoretical basis for evaluating the treatment efficacy of breast cancer patients.