Circulating Tumor Cells Screen for Breast Cancer

NCT ID: NCT05633680

Last Updated: 2023-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-20

Study Completion Date

2023-06-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasm Neoplastic Cells, Circulating

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Breast cancer group

Breast cancer is finally determined through breast puncture biopsy or excisional tissue biopsy and sent for pathological diagnosis

Peripheral blood sampling for circulating tumor cells

Intervention Type DIAGNOSTIC_TEST

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

Peripheral blood sampling for circulating tumor cells

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Handan First Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

kunwu-yan

Research Project Leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

kunwu yan, Master

Role: PRINCIPAL_INVESTIGATOR

Handan First Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kunwu Yan

Handan, Hebei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.

Reference Type BACKGROUND
PMID: 22019144 (View on PubMed)

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

Reference Type BACKGROUND
PMID: 33538338 (View on PubMed)

Chen C, Ke J, Zhou XE, Yi W, Brunzelle JS, Li J, Yong EL, Xu HE, Melcher K. Structural basis for molecular recognition of folic acid by folate receptors. Nature. 2013 Aug 22;500(7463):486-9. doi: 10.1038/nature12327. Epub 2013 Jul 14.

Reference Type BACKGROUND
PMID: 23851396 (View on PubMed)

Haber DA, Velculescu VE. Blood-based analyses of cancer: circulating tumor cells and circulating tumor DNA. Cancer Discov. 2014 Jun;4(6):650-61. doi: 10.1158/2159-8290.CD-13-1014. Epub 2014 May 6.

Reference Type BACKGROUND
PMID: 24801577 (View on PubMed)

Sparano J, O'Neill A, Alpaugh K, Wolff AC, Northfelt DW, Dang CT, Sledge GW, Miller KD. Association of Circulating Tumor Cells With Late Recurrence of Estrogen Receptor-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):1700-1706. doi: 10.1001/jamaoncol.2018.2574.

Reference Type BACKGROUND
PMID: 30054636 (View on PubMed)

Goodman CR, Seagle BL, Friedl TWP, Rack B, Lato K, Fink V, Cristofanilli M, Donnelly ED, Janni W, Shahabi S, Strauss JB. Association of Circulating Tumor Cell Status With Benefit of Radiotherapy and Survival in Early-Stage Breast Cancer. JAMA Oncol. 2018 Aug 1;4(8):e180163. doi: 10.1001/jamaoncol.2018.0163. Epub 2018 Aug 9.

Reference Type BACKGROUND
PMID: 29800954 (View on PubMed)

Banko P, Lee SY, Nagygyorgy V, Zrinyi M, Chae CH, Cho DH, Telekes A. Technologies for circulating tumor cell separation from whole blood. J Hematol Oncol. 2019 May 14;12(1):48. doi: 10.1186/s13045-019-0735-4.

Reference Type BACKGROUND
PMID: 31088479 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20200187

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

handan1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.