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

Breast Neoplasms Clinical Trial

Official title:

Identification and Characterization of Commercial RUO Antibodies for the Detection of Specific Breast Cancer Tumoral Markers Expressed in Potential Circulating Tumoral Cells (CTCs)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05054010
• Other study ID #: TET-21-001
• Status: Recruiting
• Start date: October 4, 2021
• Est. completion date: October 2023

Study information

• Verified date: March 2023
• Source: Tethis S.p.A.
• Contact: Oreste Gentilini, MD
• Phone: +390226433939
• Email: chirurgia.mammella[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

In this research study different commercial RUO (Research Use Only) antibodies will be purchased and then tested on blood samples obtained by participants affected by breast cancer and by healthy participants as control. Sixty participants will be enrolled belonging to different categories: 20 participants affected by early breast cancer, 20 participants affected by metastatic breast cancer, and 20 healthy volunteers to be used as negative control.

After signing the informed consent form, participants will be screened to evaluate if they meet the eligibility criteria. If all the criteria are met, participants will be enrolled into the study and will be asked to provide some demographic and other data. A 13 ml blood sample will be collected by the subjects and shipped to Tethis laboratories in order to be processed and analysed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Tethis S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)