Circulating Tumor Cells Screen for Breast Cancer

Active, not recruiting

• Conditions: Neoplastic Cells, Circulating; Breast Neoplasm
• Interventions: Diagnostic Test: Peripheral blood sampling for circulating tumor cells

• Registration Number: NCT05633680
• Lead Sponsor: Handan First Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2020-02-20
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-12-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-13
• Primary Completion: 2023-04-20
• Study Completion: 2023-06-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer group	Peripheral blood sampling for circulating tumor cells	Breast cancer is finally determined through breast puncture biopsy or excisional tissue biopsy and sent for pathological diagnosis
Non-breast cancer group	Peripheral blood sampling for circulating tumor cells	By breast puncture biopsy or excisional tissue biopsy and sent to pathology for final determination of benign tumor. and healthy women

Primary Outcome Measures

Name	Time	Method
Enrichment of circulating tumor cells	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.

Trial Locations

Locations (1)

Kunwu Yan; 🇨🇳 Handan, Hebei, China