Clinical trial NCT05539677: Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Solid Tumors
Primary Brain Tumor
Melanoma
Soft Tissue Sarcoma
Colorectal Cancer
Kidney Cancer
Prostate Cancer
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


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

Primary outcomes:
measure: Progression in 3 mo
timeFrame: 3 month
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 5 years
measure: Progression free survival
timeFrame: Up to 5 years
measure: Response rate
timeFrame: During the intervention
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: N.N. Petrov NMRC of Oncology, Oncoimmunology dep.
Study officials:
affiliation: N.N. Petrov NMRC of Oncology
name: Irina Baldueva, MD, PhD, DSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.