Circulating Tumor Cells Screen for Breast Cancer

NCT05633680 | Unknown DMC

• 2 other identifiers: handan120200187
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm; Neoplastic Cells, Circulating

Keywords

Breast cancer; Circulating tumor cells

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Peripheral blood sampling for circulating tumor cells 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.

Breast cancer group; Non-breast cancer group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Handan First Hospital: lead

Study Sites (1)

Kunwu Yan

Handan, Hebei, 056000, China

Location

Related Publications (7)

• 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.

  PMID: 22019144 BACKGROUND

• 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.

  PMID: 33538338 BACKGROUND

• 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.

  PMID: 23851396 BACKGROUND

• 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.

  PMID: 24801577 BACKGROUND

• 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.

  PMID: 30054636 BACKGROUND

• 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.

  PMID: 29800954 BACKGROUND

• 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.

  PMID: 31088479 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• kunwu yan, Master

  Handan First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Project Leader

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: February 20, 2020
• Primary Completion: April 20, 2023
• Study Completion: June 20, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

CN (1)