Circulating Tumor Cells Screen for Breast Cancer

Breast Neoplasm Clinical Trial

— CTCSFBC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05633680
• Other study ID #: handan1
• Secondary ID: 20200187
• Status: Active, not recruiting
• Start date: February 20, 2020
• Est. completion date: June 20, 2023

Study information

• Verified date: March 2023
• Source: Handan First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Neoplastic Cells, Circulating

Intervention

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.

Locations

Country	Name	City	State
China	Kunwu Yan	Handan	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Handan First Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrichment of circulating tumor cells	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