- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04928365
Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy
June 13, 2021 updated by: Irina Mikhaylova, Blokhin's Russian Cancer Research Center
Open Prospective Clinical Trial to Develop the Computer Software (Intelligent Prognostic System) for Predicting the Efficacy of Anti-PD-1 Immunotherapy of Melanoma Patients in Routine Practice
Open prospective clinical trial to develop the computer software (Intelligent prognostic system) for predicting the efficacy of anti-PD-1 immunotherapy of melanoma patients in routine practice
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
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
- Name: Irina N Mikhaylova, DSc
- Phone Number: 8 499 324 90 24
- Email: irmikhaylova@gmail.com
Study Locations
-
-
-
Moscow, Russian Federation, 115478
- Recruiting
- N.N. Blokhin Russian Cancer Research Center, Kashirskoye shosse 23
-
Contact:
- Irina N Mikhaylova, DSc
- Phone Number: 8 499 324 90 24
- Email: irmikhaylova@gmail.com
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Morphological verification of cutaneous melanoma. Verification of metastases is not necessary
- ECOG 0-1
- Age of patients - 18 years and older
- No prior chemotherapy, immunotherapy, radiation or hormonal therapy
- Adequate contraception for women of childbearing age
- Written consent of the patient to participate in the study
Exclusion Criteria:
- Non-compliance with the previously listed criteria
- Pregnancy and breastfeeding
- Therapy with systemic corticosteroids and/or other immunosuppressants within 4 weeks before the screening or a high probability of the need for their use during the study for the treatment of intercurrent pathology
- History of another malignancy other than the study indication under this trial within 5 years of study enrollment. Does not apply to subjects who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, in situ cervical cancer, in situ breast cancer, or other in situ cancers.
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
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Advanced melanoma patients
|
Anti-PD-1 therapy
|
Other: Stage III and IV melanoma patients after radical surgery
|
Anti-PD-1 therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival
Time Frame: up to 12 months
|
up to 12 months
|
Overall survival
Time Frame: up to 12 months
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cytokine profile
Time Frame: up to 12 months
|
IL-2, IL-6, IL-7, IL-8, IL-10, IL-12p70, IL-22, (IFN)-α2, IFN-γ, NFβ/Lymphotoxin-α(LTA), MCP-1/CCL2,IP-10/CXCL10, MIG/CXCL9, GM-CSF, PDGF-AA, PDGF-AB/BB, VEGF-A
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
March 25, 2021
Primary Completion (Actual)
May 11, 2021
Study Completion (Anticipated)
March 25, 2023
Study Registration Dates
First Submitted
June 7, 2021
First Submitted That Met QC Criteria
June 13, 2021
First Posted (Actual)
June 16, 2021
Study Record Updates
Last Update Posted (Actual)
June 16, 2021
Last Update Submitted That Met QC Criteria
June 13, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cytokim-01
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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