Clinical trial · Observational
Identification of Breast Cancer Specific Markers in Patients Compared to Healthy Participants
Identification and Characterization of Commercial RUO Antibodies for the Detection of Specific Breast Cancer Tumoral Markers Expressed in Potential Circulating Tumoral Cells (CTCs)
NCT05054010CI-TRIAL-00102193active not recruitingClinicalTrials.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)
This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of breast cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors. An amendment to the research has been proposed to enroll 24 additional participants divided into 12 patients and 12 healthy donors.
Conditions
Conditions (1)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Early Breast Cancer patients
- description
- Early stage breast cancer category is based on the definition of the European Society of medical Oncology and is defined as disease confined to the breast with or without regional lymph node involvement
- label
- Metastatic Breast Cancer patients
- description
- Metastatic breast cancer category is based on the definition of the European Society of Medical Oncology and is defined as disease spread to other parts of the body, such as bones, liver or lungs (also called stage IV). Tumours at distant sites are called metastases.
- label
- Healthy donors
- description
- Participants who are in good health and without history of cancer disease
Primary outcomes (1)
- measure
- Number of commercial Antibodies capable of Identify specific Breast Cancer Biomarkers
- timeFrame
- 1 day (at the blood draw)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant is willing and able to give and sign a written informed consent for participation in the study. * Female aged 18 years or above. * Diagnosed with early breast cancer (stage I and II) or metastatic breast cancer. * Healthy participants who visit the site for reason other than cancer diagnosis (including breast cancer). Exclusion Criteria: * History of other malignancies other than breast cancer (for healthy participants includes also breast cancer). * Undergone surgery or treatment for breast cancer before enrollment (only for early breast cancer). * Presence of known severe coagulation or haematological disorder * Known Pregnancy * Absence of written signed informed consent for participation in the study
References
Publications (8)
- BACKGROUNDHench IB, Hench J, Tolnay M. Liquid Biopsy in Clinical Management of Breast, Lung, and Colorectal Cancer. Front Med (Lausanne). 2018 Jan 30;5:9. doi: 10.3389/fmed.2018.00009. eCollection 2018. PMID 29441349
- BACKGROUNDRawal S, Yang YP, Cote R, Agarwal A. Identification and Quantitation of Circulating Tumor Cells. Annu Rev Anal Chem (Palo Alto Calif). 2017 Jun 12;10(1):321-343. doi: 10.1146/annurev-anchem-061516-045405. Epub 2017 Mar 6. PMID 28301753
- BACKGROUNDCarbone R, Marangi I, Zanardi A, Giorgetti L, Chierici E, Berlanda G, Podesta A, Fiorentini F, Bongiorno G, Piseri P, Pelicci PG, Milani P. Biocompatibility of cluster-assembled nanostructured TiO2 with primary and cancer cells. Biomaterials. 2006 Jun;27(17):3221-9. doi: 10.1016/j.biomaterials.2006.01.056. Epub 2006 Feb 28. PMID 16504283
- BACKGROUNDZanardi A, Bandiera D, Bertolini F, Corsini CA, Gregato G, Milani P, Barborini E, Carbone R. Miniaturized FISH for screening of onco-hematological malignancies. Biotechniques. 2010 Jul;49(1):497-504. doi: 10.2144/000113445. PMID 20615202
- BACKGROUNDKrol I, Schwab FD, Carbone R, Ritter M, Picocci S, De Marni ML, Stepien G, Franchi GM, Zanardi A, Rissoglio MD, Covelli A, Guidi G, Scarinci D, Castro-Giner F, Mazzarella L, Doglioni C, Borghi F, Milani P, Kurzeder C, Weber WP, Aceto N. Detection of clustered circulating tumour cells in early breast cancer. Br J Cancer. 2021 Jul;125(1):23-27. doi: 10.1038/s41416-021-01327-8. Epub 2021 Mar 24. PMID 33762721
- BACKGROUNDAceto N, Bardia A, Wittner BS, Donaldson MC, O'Keefe R, Engstrom A, Bersani F, Zheng Y, Comaills V, Niederhoffer K, Zhu H, Mackenzie O, Shioda T, Sgroi D, Kapur R, Ting DT, Moy B, Ramaswamy S, Toner M, Haber DA, Maheswaran S. AR Expression in Breast Cancer CTCs Associates with Bone Metastases. Mol Cancer Res. 2018 Apr;16(4):720-727. doi: 10.1158/1541-7786.MCR-17-0480. Epub 2018 Feb 16. PMID 29453314