Clinical trial NCT05633680: Circulating Tumor Cells Screen for Breast Cancer
Official title: Detection of Folate Receptor-positive Circulating Tumor Cells as a Biomarker for Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasm
Neoplastic Cells, Circulating
Keywords: Breast cancer
Circulating tumor cells
Lead sponsor: Handan First Hospital
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Enrichment of circulating tumor cells
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Handan
country: China
facility: Kunwu Yan
state: Hebei
Study officials:
affiliation: Handan First Hospital
name: kunwu yan, Master
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
citation: 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.