Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research

Prostate Cancer Clinical Trial

— REGATA  

Official title:

Analysis of the Immunogenetic Profile of Patients With Aggressive Course of Malignant Neoplastic Process Resistant to the Standard Treatment Approaches: a Translational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05539677
• Other study ID #: AAAA-A18-118032890188-9
• Status: Recruiting
• Start date: September 1998
• Est. completion date: December 2030

Study information

• Verified date: September 2022
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: Aleksei Novik, MD, PhD
• Phone: +78124399505
• Email: alexey.viktorovich.novik[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The investigators will collect biosamples of patient blood and tumour tissue for further immunological analysis of blood cell subpopulations, immunosupressive factors concentration, HLA expression an lymphocytes and tumour tissue, and and cancer testis antigenes expression on tumour cells, as well as clinical data on patient's stage, therapy, response and demographics. Possible prognostic and predictive dynamic biomarkers will be discovered for individualisation of treatment strategies

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Signed inform consent
• Histolgically verified solid tumour
• Receiving systemic therapy for neoplasm
• Has archival tumour tissue
• Provide biosamples with living tumour tissue or blood samples for immunologic assessment

Exclusion Criteria:

• Concurrent Lymphoprolipherative disorder
• Patients after stem cell or bone marrow thansplantation
• Incomplete informaton on previous cancer history or medical history
• Patients with known primary immunodeficiency
• Patients receiving immunosupressive therapy for concurrent illness
• Pregnant patients

Related Conditions & MeSH terms

• Brain Neoplasms
• Colorectal Cancer
• Kidney Cancer
• Kidney Neoplasms
• Malignant Solid Tumors
• Melanoma
• Neoplasms
• Primary Brain Tumor
• Prostate Cancer
• Sarcoma
• Soft Tissue Sarcoma

Locations

Country	Name	City	State
Russian Federation	N.N. Petrov NMRC of Oncology, Oncoimmunology dep.	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Petrov National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

Novik AV, Girdyuk DV, Nekhaeva TL, Emelyanova NV, Semenova A, Teletaeva GM, et al. Progression prediction model for solid tumors with clinical and immunological parameters. Journal of clinical oncology : official journal of the American Society of Clinica

Novik AV, Shendaleva N, Zozulya A, Nekhaeva TL, Semenova A, Teletaeva GM, et al. Impact of the azoximer bromide concomitant therapy on outcomes in patients with soft tissue sarcoma. Journal of clinical oncology : official journal of the American Society o

Shendaleva N, Novik AV, Zozulya A, Nekhaeva TL, Semenova A, Teletaeva GM, et al. Impact of the azoximer bromide concomitant therapy on patient outcomes in patients with melanoma. Journal of clinical oncology : official journal of the American Society of C

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression in 3 mo	Presence of disease progression within 3 mo from sample aquisition	3 month
Secondary	Overall survival (OS)	Time from sample aquisition to death from any reason	Up to 5 years
Secondary	Progression free survival	Time from sample aquisition to progression or death from the disease	Up to 5 years
Secondary	Response rate	Response assesmenr with RECIST 1.1 and iRECIST	During the intervention