Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Malignant Solid Tumors, Primary Brain Tumor, Melanoma, Soft Tissue Sarcoma. Basic parameters: from 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Primary outcome measures
- Progression in 3 mo [Time frame: 3 month]
Secondary outcome measures (3)
- Overall survival (OS) [Time frame: Up to 5 years]
- Progression free survival [Time frame: Up to 5 years]
- Response rate [Time frame: During the intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- N.N. Petrov NMRC of Oncology, Oncoimmunology dep. — Saint Petersburg
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.
Identifiers
NCT: NCT05539677 · AAAA-A18-118032890188-9