NCT04025424

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

Observational Study of Genetic Predictors of Efficiency and Safety of Immune Checkpoints Inhibitors in Patients With Different Malignancies (ICIPRESIST-0519)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Russian Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma
• Squamous Cell Lung Cancer
• Uveal Melanoma
• Hodgkin Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-06-15
• Primary completion: 2022-06-30
• Completion: 2023-12-01
• First posted: 2019-07-18
• Last updated: 2021-12-28

Locations

1 site across 1 country: Russia