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Recruiting

NCT Number: NCT05539677

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

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

Recruiting

Interested in participating?

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Key information

Conditions

Malignant Solid Tumors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Primary Brain Tumor Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Soft Tissue Sarcoma Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

N.N. Petrov NMRC of Oncology, Oncoimmunology dep.

Saint Petersburg, 197758, Russia

Location status: Recruiting

Location contact

Aleksei Novik, MD, PhD

CONTACT

[email protected]

+78124399505

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression in 3 mo

    Time frame: 3 month

    Presence of disease progression within 3 mo from sample aquisition

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to 5 years

    Time from sample aquisition to death from any reason

  2. Progression free survival

    Time frame: Up to 5 years

    Time from sample aquisition to progression or death from the disease

  3. Response rate

    Time frame: During the intervention

    Response assesmenr with RECIST 1.1 and iRECIST

Study contacts

Contact information is provided by the study sponsor or research team.

Aleksei Novik, MD, PhD

CONTACT

[email protected]

+78124399505

Tatiana Nekhaeva, MD, PhD

CONTACT

[email protected]

+78124399514

Sponsors and collaborators

Lead sponsor

N.N. Petrov National Medical Research Center of Oncology

Other

Registry information

Official study title

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

Acronym: REGATA

Important dates

Study start
1998
Primary completion
2030
Study completion
2030
First posted
Sep 14, 2022
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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