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 |
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Melanoma Squamous Cell Lung Cancer Uveal Melanoma Hodgkin Lymphoma | Genetic: Genetic tests of the available tumor and plasma samples |
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 |
Group/Cohort | Intervention/treatment |
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Skin melanoma, retrospective
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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
|
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
|
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
|
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
|
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
|
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 |
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.
Inclusion Criteria:
To participate in this study, the patient must meet the following criteria:
Specific inclusion criteria for individual cohorts:
Cohort 1 (retrospective cohort of skin melanoma patients)
Cohort 2 (Hodjkin disease - retrospective)
Cohort 3 (Uveal melanoma - retro)
Cohort 4 (melanoma of the skin - prospective)
Cohort 5 (squamous cell lung cancer - prospective)
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 3 (Uveal melanoma - retro)
- No special exclusion criteria.
Cohort 4 (melanoma of the skin - prospective)
Cohort 5 (squamous cell lung cancer - prospective)
Contact: Igor Samoylenko, MD, PhD | +79099729384 | i.samoylenko@ronc.ru | |
Contact: Irina Mikhaylova, MD, PhD | +74993249034 | i.mikhaylova@ronc.ru |
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 |
Tracking Information | |||||||||
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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 |
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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 |
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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. |
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Detailed Description | Not Provided | ||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Other |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Retention: Samples With DNA Description:
Tumor blocks and blood DNA
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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. |
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Condition |
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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
|
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
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:
Specific inclusion criteria for individual cohorts:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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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 |
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IPD Sharing Statement |
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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 |