NCT06222801

Brief Summary

Predicting the response of patients diagnosed with cancer to cytokinotherapy is essential to guide anti-tumor therapy complex strategy and subsequent adjuvant approach. Cytokinotherapy is a cost-effective, well-known available method of therapy for the patients with tumors. The objective response possibly correlates to the tumor's size, aggressiveness, age, and other primary factors. Multifactor analysis requires a large amount of data. Therefore, the investigators created the first database aimed to collect data concerning the patients with cancer and the clinical outcomes of cytokinogenetic therapy. The acquired data must be processed to detect the key factors effecting the outcomes. Cytokinotherapy is a universal therapeutic approach, although we lack information that would help to personalize it and reduce the rate of progression. The main goal is to find the relationship between initial patients' characteristics and effectiveness of cytokinotherapy for early risks detection. The predictive models that could be elaborated from the TCTD-1 analysis will complement knowledge of cytokinotherapy rationale. Predicting survival or other significant clinical criteria using TCTD-1 analysis results would greatly benefit the cancer patients' management.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
80mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Sep 2022Dec 2032

Study Start

First participant enrolled

September 19, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2032

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

June 10, 2024

Status Verified

January 1, 2024

Enrollment Period

10 years

First QC Date

December 29, 2023

Last Update Submit

June 7, 2024

Conditions

Oncology

Keywords

TNF-αTumor necrosis factor alphainterferon gammaIFN-γCancerCytokinogenetic therapy

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Number of objective responses to therapy before progression or relapse.

    10 years

Secondary Outcomes (7)

  • Changes in functional status since the start of cytokinegenetic therapy during treatment and observation.

    10 years

  • Overall survival of patients since the start of cytokinogenetic therapy.

    10 years

  • Relapse-free survival of patients since the start of cytokinogenetic therapy.

    10 years

  • The appearance of toxicity from the moment of initiation of cytokinogenetic therapy.

    10 years

  • Changes in the level of TNF in the blood since the start of cytokinegenetic therapy during treatment and observation.

    10 years

  • +2 more secondary outcomes

Interventions

Tumor necrosis factor alphaDRUG

Antitumor agent. Immunomodulatory agent.

Also known as: TNF-α, Refnot
Interferon gammaDRUG

Immunostimulating agent.

Also known as: IFN-γ, Ingaron

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an oncological diagnosis and an indication for cytokinogenetic therapy.

You may not qualify if:

  • Patients under 18 or over 95 years
  • Patients with hematologic cancer or thyroid tumors
  • Patients with contraindications for cytogenetic therapy
  • Patients who die before the start of therapy or before the first course completeness
  • Patients who do not sign the informed consent to be enrolled under the clinical observation in the hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OncocareClinic 308

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Tumor Necrosis Factor-alphaInterferon-gamma

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesMonokinesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsTumor Necrosis FactorsBlood ProteinsProteinsBiological FactorsInterferonsMacrophage-Activating FactorsLymphokines

Central Study Contacts

Artem L Kornilov, Master

CONTACT

8107 (499) 322 23 08info@oncocareclinic.ru

Tamara V Filatova, Master

CONTACT

8107 (499) 322 23 08info@oncocareclinic.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2023

First Posted

January 25, 2024

Study Start

September 19, 2022

Primary Completion (Estimated)

September 1, 2032

Study Completion (Estimated)

December 1, 2032

Last Updated

June 10, 2024

Record last verified: 2024-01

Locations

RU(1)