Evaluation of Treatment Efficacy by Circulating Tumor Cell Phenotype Surveillance in Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CTC detection.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms, Neoplastic Cells, Circulating, Chemotherapy Effect. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Surveillance of Circulating Tumor Cell Phenotype in Early Stage Breast Cancer Patients With Neoadjuvant Chemotherapy or Adjuvant Chemotherapy
Overview
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.
Detailed description
The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the treatment response of neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. This study also aims to evaluate the efficacy of CTCs surveillance in predicting invasive-disease free survival (iDFS), overall survival (OS) and metastasis. Additionally, this study evaluate the expression of PDL1 and FOXC3 on CTCs.
Interventions
- Diagnostic test CTC 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.
Primary outcome measures
- iDFS [Time frame: From date of enrollment through study completion, up to 10 years.]
Secondary outcome measures (2)
- overall survival [Time frame: From date of enrollment through study completion, up to 10 years.]
- Pathological complete response rate [Time frame: From date of enrollment up to 24 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Hunan Cancer Hospital — Changsha
Identifiers
NCT: NCT05326295 · KYJJ-2021-186