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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05539677

Acronym

REGATA

Enrollment

1000

Registered

2022-09-14

Start date

1998-09-30

Completion date

2030-12-31

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Russia

Contacts

Primary ContactAleksei Novik, MD, PhD

alexey.viktorovich.novik@gmail.com+78124399505

Backup ContactTatiana Nekhaeva, MD, PhD

nehaevat151274@mail.ru+78124399514

Outcome results