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

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

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

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Soft Tissue Sarcoma; Kidney Cancer; Colorectal Cancer; Prostate Cancer; Primary Brain Tumor; Malignant Solid Tumors

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Aleksei Novik, MD, PhD; Phone Number: +78124399505; Email: alexey.viktorovich.novik@gmail.com
• Study Contact Backup: Name: Tatiana Nekhaeva, MD, PhD; Phone Number: +78124399514; Email: nehaevat151274@mail.ru

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 197758
    • Recruiting
    • N.N. Petrov NMRC of Oncology, Oncoimmunology dep.
    • Contact: Aleksei Novik, MD, PhD; Phone Number: +78124399505; Email: alexey.viktorovich.novik@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study will include patients with solid tumours receiving systemic therapy for their disease who do not have other significant factors that affect the immune system

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
Colorectal cancer
Prostate cancer
Melanoma
Soft tissue sarcoma
Kidney cancer
Primary brain tumors
Malignant neoplasms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression in 3 mo	Presence of disease progression within 3 mo from sample aquisition	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Time from sample aquisition to death from any reason	Up to 5 years
Progression free survival	Time from sample aquisition to progression or death from the disease	Up to 5 years
Response rate	Response assesmenr with RECIST 1.1 and iRECIST	During the intervention

Collaborators and Investigators

• Sponsor: N.N. Petrov National Medical Research Center of Oncology
• Investigators: Study Director: Irina Baldueva, MD, PhD, DSc, N.N. Petrov NMRC of Oncology

Publications and helpful links

General Publications

• 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 Clinical Oncology. 2021;39(15_suppl):e21574-e.
• 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 of Clinical Oncology. 2021;39(15_suppl):e23534-e.
• 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 Clinical Oncology. 2021;39(15_suppl):2539.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 1998
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: September 4, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplasms; Sarcoma; Kidney Neoplasms; Brain Neoplasms
• Other Study ID Numbers: AAAA-A18-118032890188-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Upon completion, the database is planned to be published with depersonalized data for cohorts with meaningful data. Cohorts to be published will be defined upon data check. Partial publications could be applicable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No