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

NCT05539677 | Recruiting

• 1 other identifier: AAAA-A18-118032890188-9
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression in 3 mo

  Presence of disease progression within 3 mo from sample aquisition

  3 month

Secondary Outcomes (3)

• Overall survival (OS)

  Up to 5 years

• Progression free survival

  Up to 5 years

• Response rate

  During the intervention

Study Arms (7)

Melanoma

Soft tissue sarcoma

Kidney cancer

Primary brain tumors

Malignant neoplasms

Prostate cancer

Colorectal cancer

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead

Study Sites (1)

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

Saint Petersburg, 197758, Russia

RECRUITING

Related Publications (3)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood, peripheral blood mononuclear cells, plasma, serum, living tumor tissue, archive tumor tissue

MeSH Terms

Conditions

Brain Neoplasms; Melanoma; Sarcoma; Colorectal Neoplasms; Kidney Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Study Officials

• Irina Baldueva, MD, PhD, DSc

  N.N. Petrov NMRC of Oncology

  STUDY DIRECTOR

Central Study Contacts

Aleksei Novik, MD, PhD

CONTACT

+78124399505; alexey.viktorovich.novik@gmail.com

Tatiana Nekhaeva, MD, PhD

CONTACT

+78124399514; nehaevat151274@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 14, 2022
• Study Start: September 1, 1998
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

RU (1)