Clinical trial NCT04964271: Identification of Prostate Cancer Specific Markers in Patients Compared to Healthy Participants
Official title: Identification and Characterization of Commercial RUO Antibodies for the Detection of Specific Prostate Cancer Tumoral Markers Expressed in Potential Circulating Tumoral Cells (CTCs)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostatic Neoplasms
Keywords: prostate cancer biomarker
circulating tumoral cell
immunofluorescence assay
prostate cancer
Lead sponsor: Tethis S.p.A.
Sponsor class: INDUSTRY
First posted: 2021-07-16
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be selected from among the people who visit the urology department

Brief summary: This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of prostate cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors.

Detailed description: In this research study different commercial RUO (Research Use Only) antibodies will be purchased and then tested on blood samples obtained by patients affected by prostate cancer and by healthy participants as control. Sixty participants will be enrolled belonging to different risk categories:20 participants affected by prostate cancer at low risk, 20 participants affected by prostate cancer at high risk, and 20 participants without a cancer disease (healthy volunteers) as control.

Risk categorization is based on the definition of the European Association of Urology. 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 participants and shipped to Sponsor's laboratories, in order to be processed and analysed.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give and sign a written informed consent for participation in the study
* Male, aged 18 years or above
* Diagnosed with prostate cancer at low or high risk
* Candidate to active surveillance (in case of low-risk disease) or treatment with curative intent such as radical prostatectomy or radiation therapy (in case of low risk patients not willing to undergo active surveillance or patients with high risk disease)
* Healthy participants undergoing a visit at the site for reason other than cancer diagnosis (including prostate cancer)

Exclusion Criteria:

* History of other malignancies other than prostate cancer (for healthy participants includes also prostate cancer)
* Undergone surgery or treatment for prostate cancer before enrolment
* Presence of known severe coagulation or haematological disorder
* Absence of written signed informed consent for participation in the study

Primary outcomes:
measure: Number of commercial Antibodies capable of identify specific Prostate Cancer Biomarkers
timeFrame: day 1 : blood collection day
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Raffaele
Study officials:
affiliation: Ospedale San Raffaele
name: Alberto Briganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: Scher HI, Graf RP, Schreiber NA, McLaughlin B, Jendrisak A, Wang Y, Lee J, Greene S, Krupa R, Lu D, Bamford P, Louw JE, Dugan L, Vargas HA, Fleisher M, Landers M, Heller G, Dittamore R. Phenotypic Heterogeneity of Circulating Tumor Cells Informs Clinical Decisions between AR Signaling Inhibitors and Taxanes in Metastatic Prostate Cancer. Cancer Res. 2017 Oct 15;77(20):5687-5698. doi: 10.1158/0008-5472.CAN-17-1353. Epub 2017 Aug 17.
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.
citation: Roviello G, Corona SP, Bonetta A, Cappelletti MR, Generali D. Circulating tumor cells correlate with patterns of recurrence in patients with hormone-sensitive prostate cancer. Onco Targets Ther. 2017 Jul 31;10:3811-3815. doi: 10.2147/OTT.S143020. eCollection 2017.