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

April 5, 2022 updated by: Hunan Cancer Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410006
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Quchang Ouyang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Early stage breast cancer patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iDFS
Time Frame: From date of enrollment through study completion, up to 10 years.
The survival time from the date of tumor resection to the date of the relapse of the invasive disease.
From date of enrollment through study completion, up to 10 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: From date of enrollment through study completion, up to 10 years.
The survival time from the date of recruitment to the date of death.
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
pCR is defined as no infiltrating tumor cells in pathological examination in the primary breast and axillary lymph nodes.
From date of enrollment up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Anticipated)

March 1, 2028

Study Completion (Anticipated)

March 1, 2029

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYJJ-2021-186

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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