OncologyNCT06222801
The 1st Tumor CytokinoTherapy Database (TCTD-1)
An observational study of Oncology, run by OncoCareClinic 308 Ltd at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Oncology
- What is being tested?
- Tumor necrosis factor alpha and Interferon gamma
- How many people
- 5,000 participants
- Where
- 1 siteRussia
- Study dates
- 19 Sep 2022to 1 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an oncological diagnosis and an indication for cytokinogenetic therapy.
Who may be able to join
- 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 cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
OncocareClinic 308
Moscow
Artem L Kornilov, Master, 8107 (499) 322 23 08, info@oncocareclinic.ru
Tamara V Filatova, Master, 8107 (499) 322 23 08, info@oncocareclinic.ru
About this study
Official title: 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. 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.
Read the 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:
- To establish a longitudinal observational registry of patients with cancer based on clinical and laboratory analytical variables.
- To identify the patients with a high potential of cytokinogenetic therapy and/or low risk of complications.
- To assess the effectiveness and safety of cytogenetic therapy in patients with cancer.
- To determine the relationship between the initial patients' features and effectiveness and safety criteria (objective response, overall survival, AE rate, etc.).
- To develop a predictive model.
- To validate the model and compare it with currently available predictive models. The methodological properties of the study are described below:
- - Type of design Open prospective observational registry study.
- - Study population Patients diagnosed with neoplasia with an indication for cytogenetic therapy.
- - 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.
- -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
- - Sample size The purpose of the study is to recruit as many patients as possible among those who wish to participate.
- - 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.
- - Intervention Not applicable.
- - 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.
- Conditions
- Oncology
- Being tested
- Tumor necrosis factor alpha, Interferon gamma
- Keywords
- TNF-α, Tumor necrosis factor alpha, interferon gamma, IFN-γ, Cancer, Cytokinogenetic therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor necrosis factor alphaDrug
Also called TNF-α, Refnot
Antitumor agent. Immunomodulatory agent.
Interferon gammaDrug
Also called IFN-γ, Ingaron
Immunostimulating agent.
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Number of objective responses to therapy before progression or relapse.
Measured: 10 years
Secondary outcomes (7)
Changes in functional status since the start of cytokinegenetic therapy during treatment and observation.
The Karnofsky index parameter will be evaluated.
Measured: 10 years
Overall survival of patients since the start of cytokinogenetic therapy.
The time elapsed between the start of cytogenetic therapy and the death of the patient (for any reason, including those not related to oncology).
Measured: 10 years
Relapse-free survival of patients since the start of cytokinogenetic therapy.
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).
Measured: 10 years
The appearance of toxicity from the moment of initiation of cytokinogenetic therapy.
AEs associated with cytokine therapy.
Measured: 10 years
Changes in the level of TNF in the blood since the start of cytokinegenetic therapy during treatment and observation.
Dynamics of TNF levels in the blood throughout the study.
Measured: 10 years
Duration of response to cytokinogenetic therapy.
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.
Measured: 10 years
Disease control rate.
The number of patients who achieve disease control will be assessed every 3 months until progression or relapse occurs.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start19 Sep 2022
- Primary completion1 Sep 2032 (estimated)
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoCareClinic 308 Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222801
- Sponsor's protocol ID
- REF.AND.ING 2022
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Prospective Observational Cohort Study of the Effectiveness and Safety of Cytokinogenetic Therapy in Patients With Cancer Based on TCTD-1 Patient Registry
- ClinicalTrials.gov ID
- NCT06222801
- Acronym / sponsor ID
- REF.AND.ING 2022
- Conditions
- Oncology
- Keywords
- TNF-α, Tumor necrosis factor alpha, interferon gamma, IFN-γ, Cancer, Cytokinogenetic therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- OncoCareClinic 308 LtdUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 1 Sep 2032 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To establish a longitudinal observational registry of patients with cancer based on clinical and laboratory analytical variables.
- To identify the patients with a high potential of cytokinogenetic therapy and/or low risk of complications.
- To assess the effectiveness and safety of cytogenetic therapy in patients with cancer.
- To determine the relationship between the initial patients' features and effectiveness and safety criteria (objective response, overall survival, AE rate, etc.).
- To develop a predictive model.
- To validate the model and compare it with currently available predictive models. The methodological properties of the study are described below:
- - Type of design Open prospective observational registry study.
- - Study population Patients diagnosed with neoplasia with an indication for cytogenetic therapy.
- - 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.
- -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
- - Sample size The purpose of the study is to recruit as many patients as possible among those who wish to participate.
- - 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.
- - Intervention Not applicable.
- - 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an oncological diagnosis and an indication for cytokinogenetic therapy.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor necrosis factor alphaAlso: TNF-α, RefnotAntitumor agent. Immunomodulatory agent. | Drug | – |
| Interferon gammaAlso: IFN-γ, IngaronImmunostimulating agent. | Drug | – |
Primary outcome
Objective response rate
Time frame: 10 years
Number of objective responses to therapy before progression or relapse.
7 secondary outcomes
Changes in functional status since the start of cytokinegenetic therapy during treatment and observation.
Time frame: 10 years
Overall survival of patients since the start of cytokinogenetic therapy.
Time frame: 10 years
Relapse-free survival of patients since the start of cytokinogenetic therapy.
Time frame: 10 years
The appearance of toxicity from the moment of initiation of cytokinogenetic therapy.
Time frame: 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
Duration of response to cytokinogenetic therapy.
Time frame: 10 years
Disease control rate.
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
Related trials for Oncology
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by OncoCareClinic 308 Ltd at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Artem L Kornilov, Master (8107 (499) 322 23 08, info@oncocareclinic.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.