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Trial Title:
Circulating Tumor Cells Screen for Breast Cancer
NCT ID:
NCT05633680
Condition:
Breast Neoplasm
Neoplastic Cells, Circulating
Conditions: Official terms:
Breast Neoplasms
Neoplastic Cells, Circulating
Conditions: Keywords:
Breast cancer
Circulating tumor cells
Study type:
Observational [Patient Registry]
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Peripheral blood sampling for circulating tumor cells
Description:
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.
Arm group label:
Breast cancer group
Arm group label:
Non-breast cancer group
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Kunwu Yan
Address:
City:
Handan
Zip:
056000
Country:
China
Start date:
February 20, 2020
Completion date:
June 20, 2023
Lead sponsor:
Agency:
Handan First Hospital
Agency class:
Other
Source:
Handan First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05633680
