Clinical trial · Observational
Circulating Tumor Cells Screen for Breast Cancer
Detection of Folate Receptor-positive Circulating Tumor Cells as a Biomarker for Diagnosis
NCT05633680CI-TRIAL-00064632CTCSFBCunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplastic Cells, Circulating | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral blood sampling for circulating tumor cells | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Breast cancer group
- description
- Breast cancer is finally determined through breast puncture biopsy or excisional tissue biopsy and sent for pathological diagnosis
- interventionNames
- Diagnostic Test: Peripheral blood sampling for circulating tumor cells
- label
- Non-breast cancer group
- description
- By breast puncture biopsy or excisional tissue biopsy and sent to pathology for final determination of benign tumor. and healthy women
- interventionNames
- Diagnostic Test: Peripheral blood sampling for circulating tumor cells
Primary outcomes (1)
- measure
- Enrichment of circulating tumor cells
- timeFrame
- 1 week
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDEarly 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
- BACKGROUNDSung 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
- BACKGROUNDChen 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
- BACKGROUNDHaber 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
- BACKGROUNDSparano 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
- BACKGROUNDGoodman 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.