The 1st Tumor CytokinoTherapy Database (TCTD-1)

January 15, 2024 updated by: OncoCareClinic 308 Ltd

Open Prospective Observational Cohort Study of the Effectiveness and Safety of Cytokinogenetic Therapy in Patients With Cancer Based on TCTD-1 Patient Registry

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. The rationale is that cytokinotherapy is a universal therapeutic approach, although the absence of information that can help personalize it and decrease the rate of progression. The main goal is to find the relationship between initial patients' characteristics and effectiveness of cytokinotherapy for early risks detectioon. The predictive models that can 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators plan to carry out an open prospective observational cohort study during 10 years based on TCTD-1 registry of patients with cancer diagnoses in order to assess the effectiveness and safety of cytogenetic therapy. Demographic, clinical, radiological, genetical and laboratory variables (TNF alpha) will also be collected. OS will be defined as the time elapsed between the application for cytogenetic therapy with cancer diagnosis and the patient's death.

Objectives:

  1. To establish a longitudinal observational registry of patients with cancer based on clinical and laboratory analytical variables.
  2. To identify the patients with a high potential of cytokinogenetic therapy and/or low risk of complications.
  3. To assess the effectiveness and safety of cytogenetic therapy in patients with cancer.
  4. To determine the relationship between the initial patients' features and effectiveness and safety criteria (objective response, overall survival, AE rate, etc.).
  5. To develop a predictive model.

  6. To validate the model and compare it with currently available predictive models.

    The methodological properties of the study are described below:

  7. - Type of design Open prospective observational registry study.
  8. - Study population Patients diagnosed with neoplasia with an indication for cytogenetic therapy.
  9. - Inclusion and exclusion criteria Adult patients aged 18 years or older with cancer who do not meet exclusion criteria, applied to the OncoCare308 Clinic Ltd. hospital for cytogenetic therapy, and are eligible to complete or have completed at least one course of cytogenetic therapy, as determined by the site, who do not meet any exclusion criteria.

  10. -The study exclusion criteria are:

    • 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
  11. - Sample size The purpose of the study is to recruit as many patients as possible among those who wish to participate.
  12. - Recruitment Once the enrollment criteria have been assessed, each patient will be assigned a unique code that will be used to anonymously manage any of the information obtained during the study. Thus, the confidentiality of the data will be guaranteed at all times from the moment of recruitment.
  13. - Intervention Not applicable.
  14. - Follow up The patient will be monitored for at least 4 years up to 10 years, compiling all the specific variables of this study and the possible complications and mortality that occurred in this period.

Study Type

Observational

Enrollment (Estimated)

5000

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • adult patients aged 18 years or older with cancer who do not meet exclusion criteria, applied to the OncoCare308 Clinic Ltd. hospital for cytogenetic therapy, and are eligible to complete or have completed at least one course of cytogenetic therapy, as determined by the site.

Exclusion Criteria:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 10 years
Number of objective responses to therapy before progression or relapse.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in functional status since the start of cytokinegenetic therapy during treatment and observation.
Time Frame: 10 years
The Karnofsky index parameter will be evaluated.
10 years
Overall survival of patients since the start of cytokinogenetic therapy.
Time Frame: 10 years
The time elapsed between the start of cytogenetic therapy and the death of the patient (for any reason, including those not related to oncology).
10 years
Relapse-free survival of patients since the start of cytokinogenetic therapy.
Time Frame: 10 years
The time elapsed between the start of cytokinogenetic therapy and the detection of relapse or death of the patient (for any reason, including those not related to oncology).
10 years
The appearance of toxicity from the moment of initiation of cytokinogenetic therapy.
Time Frame: 10 years
AEs associated with cytokine therapy.
10 years
Changes in the level of TNF in the blood since the start of cytokinegenetic therapy during treatment and observation.
Time Frame: 10 years
Dynamics of TNF levels in the blood throughout the study.
10 years
Duration of response to cytokinogenetic therapy.
Time Frame: 10 years
Duration of response to therapy as time to event (progression or relapse). Analysis of duration of response will be performed in the group of patients who responded to therapy.
10 years
Disease control rate.
Time Frame: 10 years
The number of patients who achieve disease control will be assessed every 3 months until progression or relapse occurs.
10 years

Collaborators and Investigators

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

Sponsor

OncoCareClinic 308 Ltd

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 19, 2022

Primary Completion (Estimated)

September 1, 2032

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

December 29, 2023

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REF.AND.ING 2022

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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