Identification of Breast Cancer Specific Markers in Patients Compared to Healthy Participants

NCT05054010 | Active Not Recruiting

• 1 other identifier: TET-21-001
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Neoplasms

Keywords

Breast Cancer Biomarker; Circulating Tumoral Cell; Immunofluorescence Assay; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of commercial Antibodies capable of Identify specific Breast Cancer Biomarkers

  Qualitative Assessment of Staining Positivity for different Breast Cancer Biomarkers

  1 day (at the blood draw)

Study Arms (3)

Early Breast Cancer patients

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

Metastatic Breast Cancer patients

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.

Healthy donors

Participants who are in good health and without history of cancer disease

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be selected from among the people who visit the Breast Surgery department

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Tethis S.p.A.: lead

Study Sites (1)

Ospedale San Raffaele

Milan, 20132, Italy

Location

Related Publications (8)

• Hench 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 BACKGROUND

• Rawal 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 BACKGROUND

• Carbone 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 BACKGROUND

• Zanardi 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 BACKGROUND

• Krol 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 BACKGROUND

• Aceto 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 BACKGROUND

• Xu L, Jia S, Li H, Yu Y, Liu G, Wu Y, Liu X, Liu C, Zhou Y, Zhang Z, Sheng Y. Characterization of circulating tumor cells in newly diagnosed breast cancer. Oncol Lett. 2018 Feb;15(2):2522-2528. doi: 10.3892/ol.2017.7540. Epub 2017 Dec 6.

  PMID: 29434968 BACKGROUND

• Fujii T, Reuben JM, Huo L, Espinosa Fernandez JR, Gong Y, Krupa R, Suraneni MV, Graf RP, Lee J, Greene S, Rodriguez A, Dugan L, Louw J, Lim B, Barcenas CH, Marx AN, Tripathy D, Wang Y, Landers M, Dittamore R, Ueno NT. Androgen receptor expression on circulating tumor cells in metastatic breast cancer. PLoS One. 2017 Sep 28;12(9):e0185231. doi: 10.1371/journal.pone.0185231. eCollection 2017.

  PMID: 28957377 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Oreste Gentilini, MD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 23, 2021
• Study Start: October 4, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)