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

Sponsor

N.N. Petrov National Medical Research Center of Oncology (Other)

Overall Status

Recruiting

CT.gov ID

NCT05539677

Collaborator

(none)

1,000

Enrollment

Location

387

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Malignant Solid Tumors Primary Brain Tumor Melanoma Soft Tissue Sarcoma Colorectal Cancer Kidney Cancer Prostate Cancer

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Sep 1, 1998

Anticipated Primary Completion Date :

Dec 1, 2030

Anticipated Study Completion Date :

Dec 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Melanoma
Soft tissue sarcoma
Kidney cancer
Primary brain tumors
Malignant neoplasms
Prostate cancer
Colorectal cancer

Outcome Measures

Primary Outcome Measures

Progression in 3 mo [3 month]
Presence of disease progression within 3 mo from sample aquisition

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	N.N. Petrov NMRC of Oncology, Oncoimmunology dep.	Saint Petersburg		Russian Federation	197758

Sponsors and Collaborators

N.N. Petrov National Medical Research Center of Oncology

Investigators

Study Director: Irina Baldueva, MD, PhD, DSc, N.N. Petrov NMRC of Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

N.N. Petrov National Medical Research Center of Oncology

ClinicalTrials.gov Identifier:

NCT05539677

Other Study ID Numbers:

AAAA-A18-118032890188-9

First Posted:

Sep 14, 2022

Last Update Posted:

Sep 14, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2022