Circulating Tumor Cells Screen for Breast Cancer (CTCSFBC)

March 10, 2023 updated by: kunwu-yan, Handan First Hospital

Detection of Folate Receptor-positive Circulating Tumor Cells as a Biomarker for Diagnosis

A prospective study was used to collect patients considering breast cancer admitted to our general surgery department from 2019-6 to 2023-8, to identify the case group (breast cancer) and the control group (non-breast cancer), to compare the differences in CTC in peripheral blood between the two groups, and to draw conclusions after statistical analysis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This project is a prospective study by collecting clinical data from breast cancer and non-breast cancer patients admitted to our general surgery department from 2020 to 2023, and drawing peripheral blood for CTC testing. The clinical data of 200 patients were initially collected and grouped, with the study group positioned as breast cancer patients (patients with pathologically determined breast cancer) and the control group as non-breast cancer patients (patients with benign breast tumors and healthy women), to investigate the expression of CTC in breast cancer and correlation with the degree of metastasis, as well as to further understand the relationship between CTC in peripheral blood and breast cancer clinicopathology. The circulating tumor cell enrichment was compared between the two groups, and the data were derived for statistical analysis to draw conclusions, as well as to identify shortcomings and make improvements to the existing problems.

Study Type

Observational

Enrollment (Anticipated)

200

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
    • Hebei
      • Handan, Hebei, China, 056000
        • Kunwu Yan

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

patients with a clinical diagnosis of breast cancer, patients with benign breast disease (BBD), and healthy females were recruited for this study, Patients with benign breast disease and healthy women as negative controls.

Description

Inclusion Criteria:

Clinical diagnosis of breast cancer Must be able to cooperate with the examination

Exclusion Criteria:

patients were currently undergoing or had prior cancer treatment; patients had other conditions which investigators thought not suitable for the 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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer group
Breast cancer is finally determined through breast puncture biopsy or excisional tissue biopsy and sent for pathological diagnosis
Diagnostic test: Peripheral blood sampling for circulating tumor cells
Patients had 3-4 ml of venous blood drawn on day 1 after admission, ethylene diamine tetra acetic acid (EDTA) was used for anticoagulation, samples were stored at 4 ℃, and CTCs analysis was performed within 24 hours after collection. .FU/3 ml was used as the unit for CTC quantification.
Non-breast cancer group
By breast puncture biopsy or excisional tissue biopsy and sent to pathology for final determination of benign tumor. and healthy women
Diagnostic test: Peripheral blood sampling for circulating tumor cells
Patients had 3-4 ml of venous blood drawn on day 1 after admission, ethylene diamine tetra acetic acid (EDTA) was used for anticoagulation, samples were stored at 4 ℃, and CTCs analysis was performed within 24 hours after collection. .FU/3 ml was used as the unit for CTC quantification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrichment of circulating tumor cells
Time Frame: 1 week
The main test was the enrichment of circulating tumor cells in the peripheral blood of the two groups of patients.FU/3 ml was used as the unit for CTC quantification.
1 week

Collaborators and Investigators

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

Sponsor

Handan First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 20, 2020

Primary Completion (Anticipated)

April 20, 2023

Study Completion (Anticipated)

June 20, 2023

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • handan1
  • 20200187 (Other Grant/Funding Number: 2020 Hebei Provincial Health Commission Youth Project Fund Project)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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