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出境医 / 临床实验 / Genetic Predictors of Efficiency and Safety of ICIs in Patients With Different Malignancies (ICIPRESIST-0519) (ICIPRESIST19)

Genetic Predictors of Efficiency and Safety of ICIs in Patients With Different Malignancies (ICIPRESIST-0519) (ICIPRESIST19)

Study Description
Brief Summary:

This is a multicenter, non-interventional, retrospective study (with two prospective cohorts), including previously treated patients with melanoma, squamous cell lung cancer in the late stages (inoperable or metastatic) and Hodgkin disease at any stages.

The duration of the follow-up will be 12-60 months. Data from medical records will be retrospectively collected at different points in time. The first data extraction will consist of collecting data from the initial level (before treatment with immune checkpoints inhibitors (anti-PD1 / PDl1) before the end of the recruitment period for this study (up to 3 years of follow-up). Two additional annual data collections are planned for display additional follow-up and data for patients who will survive.


Condition or disease Intervention/treatment
Melanoma Squamous Cell Lung Cancer Uveal Melanoma Hodgkin Lymphoma Genetic: Genetic tests of the available tumor and plasma samples

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Observational Study of Genetic Predictors of Efficiency and Safety of Immune Checkpoints Inhibitors in Patients With Different Malignancies (ICIPRESIST-0519)
Actual Study Start Date : June 15, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 1, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Skin melanoma, retrospective
  • 1) Clinically and morphologically verified diagnosis of skin melanoma or melanoma metastases without an identified primary lesion;
  • 2) The availability of basic clinical information about the patient and the course of his illness;
Genetic: Genetic tests of the available tumor and plasma samples
Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned

Hodgkin disease, retrospective
  • 1) Clinically and morphologically verified diagnosis of Hodgkin disease (any histological variant);
  • 2) The availability of basic clinical information about the patient and the course of his illness;
Genetic: Genetic tests of the available tumor and plasma samples
Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned

Uveal melanoma, retrospective
  • 1) Clinically and morphologically verified diagnosis of uveal melanoma (any histological variant);
  • 2) The availability of basic clinical information about the patient and the course of his il
Genetic: Genetic tests of the available tumor and plasma samples
Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned

Skin melanoma, proscpective
  • 1) Clinically and morphologically verified diagnosis of metastatic melanoma;
  • 2) The availability of basic clinical information about the patient and the course of his illness;
Genetic: Genetic tests of the available tumor and plasma samples
Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned

Lung cancer, procpective
  • 1) Clinically and morphologically verified diagnosis of metastatic or inoperable squamous cell lung cancer;
  • 2) The availability of basic clinical information about the patient and the course of his illness;
  • 3) The presence of indications for therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy;
Genetic: Genetic tests of the available tumor and plasma samples
Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned

Outcome Measures
Primary Outcome Measures :
  1. overall survival (OS) of patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and lymphoma granulomatosis [ Time Frame: dec 2021 ]
    Overall survival (OS) will be calculated and presented in graphical form using the method of the product of Kaplan-Meier limits. The report will include a median of C with corresponding bilateral values of 95% CI. The proportion of patients who survive at certain points in time (1, 2, and 3 years), as well as the corresponding bilateral values of 95% CI, will be evaluated and reported.

  2. incidence and severity of all adverse events (AEs) in patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and lymphoma. [ Time Frame: dec 2021 ]

Other Outcome Measures:
  1. progression-free survival (PFS) in patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and Hodgkin disease [ Time Frame: dec 2021 ]
  2. response rate in patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and Hodgkin disease [ Time Frame: dec 2021 ]
  3. Development of predictive molecular testing tools [ Time Frame: dec 2021 ]
    The predictive power parameters of the predictive tools being developed will be generalized using descriptive statistics methods. The significance of the results of the qualitative tests will be assessed using Fisher's two-sided exact test. The optimal threshold values for quantitative tests will be evaluated using the ROC curve method, and for the mutational load, the four squares method of Abeshouse, 2017 will also be calculated. using the proportional Cox test.


Biospecimen Retention:   Samples With DNA
Tumor blocks and blood DNA

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The target sample consists of approximately 350 treated patients, treatment of patients with melanoma, squamous cell lung cancer in the late stages (inoperable or metastatic) and Hodgkin dsisease, who met the criteria.

The current study will be conducted in selected research centers where at least 5 patients are treated with blockers of immune checkpoints during the quarter (3 months) in the period from 2015 to 2019. In each research center, patients will be identified that meet the inclusion criteria, based on the lists of patients who received therapy with blockers of immune checkpoints in specific research centers. The study is conducted only in centers located in Russia.

Criteria

Inclusion Criteria:

To participate in this study, the patient must meet the following criteria:

  • At least 2 injections (or 10 weeks) of ICI (PD1, PDl1 blockers, including but not limited to such drugs as nivolumab, pembrolizumab, prolglimab, atezolizumab, avelumab, durvalumab, spratalizumab)
  • Deceased patients meet the criteria; signing the informed consent of the legal representative of the deceased patient is not required

Specific inclusion criteria for individual cohorts:

  • Cohort 1 (retrospective cohort of skin melanoma patients)

    • 1) Clinically and morphologically verified diagnosis of skin melanoma or melanoma metastases without an identified primary focus;
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    • 3) Therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy (at least 2 injections);
    • 4) Evaluation of the effect of immunotherapy
    • 5) Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic studies, obtained no earlier than 24 months. before initiating therapy with a PD-1 or PD-L1 inhibitor;
    • 8) Patient-signed informed consent in case the patient is alive
  • Cohort 2 (Hodjkin disease - retrospective)

    • 1) Clinically and morphologically verified diagnosis of Hodgkin disease (any histological variant);
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    • 3) Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic studies;
    • 4) Patient signed informed consent.
  • Cohort 3 (Uveal melanoma - retro)

    • 1) Clinically and morphologically verified diagnosis of uveal melanoma (any histological variant);
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    • 3) Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic studies;
    • 4) Patient signed informed consent.
  • Cohort 4 (melanoma of the skin - prospective)

    • 1) Clinically and morphologically verified diagnosis of metastatic melanoma;
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    • 3) Indications for therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy;
    • 4) The possibility of including the patient in the present study before the first course of immunotherapy;
    • 5) Availability of tumor material (paraffin blocks and histological glass preparations) for morphological, immunohistochemical and molecular genetic studies obtained no earlier than 2 years before the planned start of immunotherapy with a standard PD-1 inhibitor;
    • 6) Separate patient consent to a repeated biopsy of the tumor focus before the planned start of immunotherapy with a PD-1 or PD-L1 inhibitor, if the existing tumor material was obtained earlier than 2 years before the planned start of immunotherapy
    • 7) Availability of samples of biological fluids collected before the start of immunotherapy and after the first course of immunotherapy for molecular genetic studies of circulating tumor DNA;
    • 8) Evaluation of the effect of therapy in the framework of local practice in accordance with the criteria of RECIST 1.1
    • 9) Signed by the patient informed consent to participate in the study.
  • Cohort 5 (squamous cell lung cancer - prospective)

    • 1) Clinically and morphologically verified diagnosis of metastatic or inoperable squamous cell lung cancer;
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    • 3) The presence of indications for therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy;
    • 4) The possibility of including the patient in the present study before the first course of immunotherapy;
    • 5) Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic research, obtained no earlier than 2 years before the planned start of immunotherapy with a standard PD-1 inhibitor;
    • 6) Separate patient consent to a repeated biopsy of the tumor focus before the planned start of immunotherapy with a PD-1 or PD-L1 inhibitor, if the existing tumor material was obtained earlier than 2 years before the planned start of immunotherapy
    • 7) Availability of samples of biological fluids collected before the start of immunotherapy and after the first course of immunotherapy for molecular genetic studies of circulating tumor DNA;
    • 8) Evaluation of the effect of therapy in the framework of local practice in accordance with the criteria of RECIST 1.1
    • 9) Signed by the patient informed consent to participate in the study.

Exclusion Criteria:

  • Cohort 1 (retrospective cohort of skin melanoma patients)

    - 1) It is not allowed to conduct other immunotherapy (anti-CTLA4, vaccines, etc.) to patients before the course of therapy with a PD-1 or PD-L1 inhibitor in a standard dosage in monotherapy

  • Cohort 2 (Hodgkin disease - retrospective)
  • no special exclusion criteria
  • Cohort 3 (Uveal melanoma - retro)

    - No special exclusion criteria.

  • Cohort 4 (melanoma of the skin - prospective)

    • 1) It is not allowed to include patients who have previously undergone other immunotherapy (anti-CTLA4, vaccines, etc.) before the course of therapy with the PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy
    • 2) It is not allowed to include patients who are scheduled for combination immunotherapy (anti-PD1 + anti-CTLA4, vaccines, etc.) after inclusion in this study
  • Cohort 5 (squamous cell lung cancer - prospective)

    • 1) It is not allowed to include patients who have previously undergone other immunotherapy (anti-CTLA4, vaccines, etc.) before the course of therapy with the PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy
    • 2) It is not allowed to include patients who are scheduled for combination immunotherapy (anti-PD1 + anti-CTLA4, vaccines, etc.) after inclusion in this study.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Igor Samoylenko, MD, PhD +79099729384 i.samoylenko@ronc.ru
Contact: Irina Mikhaylova, MD, PhD +74993249034 i.mikhaylova@ronc.ru

Locations
Layout table for location information
Russian Federation
N.N. Blokhin Russian Cancer Research Center Recruiting
Moscow', Москва, Russian Federation, 115478
Contact: Igor Samoylenko, MD, PhD    +79099729384    i.samoylenko@ronc.ru   
Contact: Kirill Baryshnikov, MD, PhD    +79671751112    k.baryshnikov@ronc.ru   
Sponsors and Collaborators
Russian Academy of Medical Sciences
Tracking Information
First Submitted Date July 17, 2019
First Posted Date July 18, 2019
Last Update Posted Date September 11, 2019
Actual Study Start Date June 15, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2019)
  • overall survival (OS) of patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and lymphoma granulomatosis [ Time Frame: dec 2021 ]
    Overall survival (OS) will be calculated and presented in graphical form using the method of the product of Kaplan-Meier limits. The report will include a median of C with corresponding bilateral values of 95% CI. The proportion of patients who survive at certain points in time (1, 2, and 3 years), as well as the corresponding bilateral values of 95% CI, will be evaluated and reported.
  • incidence and severity of all adverse events (AEs) in patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and lymphoma. [ Time Frame: dec 2021 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 17, 2019)
  • progression-free survival (PFS) in patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and Hodgkin disease [ Time Frame: dec 2021 ]
  • response rate in patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and Hodgkin disease [ Time Frame: dec 2021 ]
  • Development of predictive molecular testing tools [ Time Frame: dec 2021 ]
    The predictive power parameters of the predictive tools being developed will be generalized using descriptive statistics methods. The significance of the results of the qualitative tests will be assessed using Fisher's two-sided exact test. The optimal threshold values for quantitative tests will be evaluated using the ROC curve method, and for the mutational load, the four squares method of Abeshouse, 2017 will also be calculated. using the proportional Cox test.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Genetic Predictors of Efficiency and Safety of ICIs in Patients With Different Malignancies (ICIPRESIST-0519)
Official Title Observational Study of Genetic Predictors of Efficiency and Safety of Immune Checkpoints Inhibitors in Patients With Different Malignancies (ICIPRESIST-0519)
Brief Summary

This is a multicenter, non-interventional, retrospective study (with two prospective cohorts), including previously treated patients with melanoma, squamous cell lung cancer in the late stages (inoperable or metastatic) and Hodgkin disease at any stages.

The duration of the follow-up will be 12-60 months. Data from medical records will be retrospectively collected at different points in time. The first data extraction will consist of collecting data from the initial level (before treatment with immune checkpoints inhibitors (anti-PD1 / PDl1) before the end of the recruitment period for this study (up to 3 years of follow-up). Two additional annual data collections are planned for display additional follow-up and data for patients who will survive.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumor blocks and blood DNA
Sampling Method Non-Probability Sample
Study Population

The target sample consists of approximately 350 treated patients, treatment of patients with melanoma, squamous cell lung cancer in the late stages (inoperable or metastatic) and Hodgkin dsisease, who met the criteria.

The current study will be conducted in selected research centers where at least 5 patients are treated with blockers of immune checkpoints during the quarter (3 months) in the period from 2015 to 2019. In each research center, patients will be identified that meet the inclusion criteria, based on the lists of patients who received therapy with blockers of immune checkpoints in specific research centers. The study is conducted only in centers located in Russia.

Condition
  • Melanoma
  • Squamous Cell Lung Cancer
  • Uveal Melanoma
  • Hodgkin Lymphoma
Intervention Genetic: Genetic tests of the available tumor and plasma samples
Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned
Study Groups/Cohorts
  • Skin melanoma, retrospective
    • 1) Clinically and morphologically verified diagnosis of skin melanoma or melanoma metastases without an identified primary lesion;
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    Intervention: Genetic: Genetic tests of the available tumor and plasma samples
  • Hodgkin disease, retrospective
    • 1) Clinically and morphologically verified diagnosis of Hodgkin disease (any histological variant);
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    Intervention: Genetic: Genetic tests of the available tumor and plasma samples
  • Uveal melanoma, retrospective
    • 1) Clinically and morphologically verified diagnosis of uveal melanoma (any histological variant);
    • 2) The availability of basic clinical information about the patient and the course of his il
    Intervention: Genetic: Genetic tests of the available tumor and plasma samples
  • Skin melanoma, proscpective
    • 1) Clinically and morphologically verified diagnosis of metastatic melanoma;
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    Intervention: Genetic: Genetic tests of the available tumor and plasma samples
  • Lung cancer, procpective
    • 1) Clinically and morphologically verified diagnosis of metastatic or inoperable squamous cell lung cancer;
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    • 3) The presence of indications for therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy;
    Intervention: Genetic: Genetic tests of the available tumor and plasma samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 17, 2019)
350
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2022
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

To participate in this study, the patient must meet the following criteria:

  • At least 2 injections (or 10 weeks) of ICI (PD1, PDl1 blockers, including but not limited to such drugs as nivolumab, pembrolizumab, prolglimab, atezolizumab, avelumab, durvalumab, spratalizumab)
  • Deceased patients meet the criteria; signing the informed consent of the legal representative of the deceased patient is not required

Specific inclusion criteria for individual cohorts:

  • Cohort 1 (retrospective cohort of skin melanoma patients)

    • 1) Clinically and morphologically verified diagnosis of skin melanoma or melanoma metastases without an identified primary focus;
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    • 3) Therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy (at least 2 injections);
    • 4) Evaluation of the effect of immunotherapy
    • 5) Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic studies, obtained no earlier than 24 months. before initiating therapy with a PD-1 or PD-L1 inhibitor;
    • 8) Patient-signed informed consent in case the patient is alive
  • Cohort 2 (Hodjkin disease - retrospective)

    • 1) Clinically and morphologically verified diagnosis of Hodgkin disease (any histological variant);
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    • 3) Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic studies;
    • 4) Patient signed informed consent.
  • Cohort 3 (Uveal melanoma - retro)

    • 1) Clinically and morphologically verified diagnosis of uveal melanoma (any histological variant);
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    • 3) Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic studies;
    • 4) Patient signed informed consent.
  • Cohort 4 (melanoma of the skin - prospective)

    • 1) Clinically and morphologically verified diagnosis of metastatic melanoma;
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    • 3) Indications for therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy;
    • 4) The possibility of including the patient in the present study before the first course of immunotherapy;
    • 5) Availability of tumor material (paraffin blocks and histological glass preparations) for morphological, immunohistochemical and molecular genetic studies obtained no earlier than 2 years before the planned start of immunotherapy with a standard PD-1 inhibitor;
    • 6) Separate patient consent to a repeated biopsy of the tumor focus before the planned start of immunotherapy with a PD-1 or PD-L1 inhibitor, if the existing tumor material was obtained earlier than 2 years before the planned start of immunotherapy
    • 7) Availability of samples of biological fluids collected before the start of immunotherapy and after the first course of immunotherapy for molecular genetic studies of circulating tumor DNA;
    • 8) Evaluation of the effect of therapy in the framework of local practice in accordance with the criteria of RECIST 1.1
    • 9) Signed by the patient informed consent to participate in the study.
  • Cohort 5 (squamous cell lung cancer - prospective)

    • 1) Clinically and morphologically verified diagnosis of metastatic or inoperable squamous cell lung cancer;
    • 2) The availability of basic clinical information about the patient and the course of his illness;
    • 3) The presence of indications for therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy;
    • 4) The possibility of including the patient in the present study before the first course of immunotherapy;
    • 5) Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic research, obtained no earlier than 2 years before the planned start of immunotherapy with a standard PD-1 inhibitor;
    • 6) Separate patient consent to a repeated biopsy of the tumor focus before the planned start of immunotherapy with a PD-1 or PD-L1 inhibitor, if the existing tumor material was obtained earlier than 2 years before the planned start of immunotherapy
    • 7) Availability of samples of biological fluids collected before the start of immunotherapy and after the first course of immunotherapy for molecular genetic studies of circulating tumor DNA;
    • 8) Evaluation of the effect of therapy in the framework of local practice in accordance with the criteria of RECIST 1.1
    • 9) Signed by the patient informed consent to participate in the study.

Exclusion Criteria:

  • Cohort 1 (retrospective cohort of skin melanoma patients)

    - 1) It is not allowed to conduct other immunotherapy (anti-CTLA4, vaccines, etc.) to patients before the course of therapy with a PD-1 or PD-L1 inhibitor in a standard dosage in monotherapy

  • Cohort 2 (Hodgkin disease - retrospective)
  • no special exclusion criteria
  • Cohort 3 (Uveal melanoma - retro)

    - No special exclusion criteria.

  • Cohort 4 (melanoma of the skin - prospective)

    • 1) It is not allowed to include patients who have previously undergone other immunotherapy (anti-CTLA4, vaccines, etc.) before the course of therapy with the PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy
    • 2) It is not allowed to include patients who are scheduled for combination immunotherapy (anti-PD1 + anti-CTLA4, vaccines, etc.) after inclusion in this study
  • Cohort 5 (squamous cell lung cancer - prospective)

    • 1) It is not allowed to include patients who have previously undergone other immunotherapy (anti-CTLA4, vaccines, etc.) before the course of therapy with the PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy
    • 2) It is not allowed to include patients who are scheduled for combination immunotherapy (anti-PD1 + anti-CTLA4, vaccines, etc.) after inclusion in this study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Igor Samoylenko, MD, PhD +79099729384 i.samoylenko@ronc.ru
Contact: Irina Mikhaylova, MD, PhD +74993249034 i.mikhaylova@ronc.ru
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT04025424
Other Study ID Numbers ICIPRESIST-052019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Igor Samoylenko, Russian Academy of Medical Sciences
Study Sponsor Russian Academy of Medical Sciences
Collaborators Not Provided
Investigators Not Provided
PRS Account Russian Academy of Medical Sciences
Verification Date September 2019

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