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

May 3, 2024 updated by: N.N. Petrov National Medical Research Center of Oncology

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

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: 3 month
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 Frame: Up to 5 years
Time from sample aquisition to death from any reason
Up to 5 years
Progression free survival
Time Frame: Up to 5 years
Time from sample aquisition to progression or death from the disease
Up to 5 years
Response rate
Time Frame: During the intervention
Response assesmenr with RECIST 1.1 and iRECIST
During the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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