Irkutsk

Researchers are evaluating the safety and effectiveness of BCD-248 combined with daratumumab compared to a combination of daratumumab, pomalidomide, and dexamethasone for treating adults with relapsed or refractory multiple myeloma. This study focuses on participants aged 18 and older who have measurable multiple myeloma and have received previous treatments including a proteasome inhibitor and lenalidomide, specifically those who are refractory to lenalidomide or have had disease progression after prior therapies. Participants will receive either BCD-248 administered under the skin with daratumumab given intravenously, or the combination of daratumumab intravenously with pomalidomide and dexamethasone taken orally. The study is randomized without masking, comparing these two treatment groups in parallel. The intervention period includes monitoring for up to 36 months to assess disease progression and response, with additional long-term evaluations lasting up to 5 years. During the trial, participants will undergo assessments including measuring minimal residual disease using flow cytometry at 12 months, and monitoring progression-free survival per established criteria. Other evaluations include response rates, survival, immune markers, and adverse events over several years. Safety and treatment effects will be closely followed with regular clinical visits and laboratory tests throughout the study duration, which extends until October 2032.

Researchers are studying aggressive high-volume metastatic hormone-sensitive prostate cancer mHSPC in male patients in the Russian Federation. This observational study focuses on treatment patterns and the evaluation of homologous recombination repair mutations HRRm in circulating tumor DNA ctDNA. The study aims to better understand demographic and clinical characteristics along with how patients with different HRR gene statuses are treated. The study enrolls about 400 male patients with high-aggressive Gleason 8-10 and high-volume mHSPC who have known tumor HRRm status from routine tumor samples. No additional procedures beyond routine clinical care are performed. Data are collected during two visits a baseline visit where medical history and treatment approaches since diagnosis are recorded, and a final visit at disease progression or after about 12 months to gather follow-up treatment and progression information. Blood samples for ctDNA and HRRm testing are collected from routine blood draws and analyzed centrally. Participants contribute data through medical record reviews and, if needed, patient interviews. Researchers collect information on treatments received, disease progression, lab tests, and mutation presence. The study evaluates various outcomes including treatment proportions, therapy durations, progression times, and mutation rates over 36 months. Data are entered into electronic forms, and follow-up may occur by phone if in-person visits are not possible. The total study duration is about 38 months or until all data are collected.

Researchers are conducting a national, multi-center, prospective study to collect real-world data on patients in the Russian Federation with advanced and aggressive endometrial cancer, specifically stage III-IV disease. The study focuses on molecular profiling markers such as POLE mutations, dMMRpMMR, p53 abnormalities, HER2 expression, and PD-L1 status, alongside demographic and clinical characteristics. It aims to understand first-line postoperative treatment approaches in these patients. The study involves no additional procedures beyond routine clinical practice. Patients provide archival tumor tissue samples obtained from biopsy or post-operative formalin-fixed paraffin-embedded FFPE blocks for molecular testing. Testing uses immunohistochemistry IHC for certain markers and next-generation sequencing NGS or polymerase chain reaction PCR for POLE mutations. Data will be collected at two visits a baseline visit to gather clinical and demographic information and tissue testing results, and a final visit 6 months later or at disease progression to collect follow-up treatment and progression data. Participants data and outcomes will be recorded in an electronic case report form. The study measures include rates of positive molecular markers and various clinical and treatment-related outcomes over 24 to 33 months. Approximately 500 patients will be enrolled across about 30 sites. The overall study duration is about 27 months or until data collection for all patients is complete.

Researchers are conducting an observational multicenter cross-sectional study involving 5,000 adult patients in Russia with uncontrolled severe asthma SA who are receiving standard care treatments except biologics. The study aims to describe the characteristics of these patients across about 50 outpatient centers in 50 regions of Russia, addressing the lack of unified data on severe asthma epidemiology, complications, comorbidities, and treatment patterns in the country. Participants will have a single study visit where demographic and clinical data will be collected without any additional interventions or changes to their routine care. The study will gather information on treatment patterns, including the use of oral corticosteroids and various medication classes, and analyze clinical and demographic features such as age at diagnosis, gender distribution, body mass index, lifestyle factors, and presence of comorbidities. During the study, researchers will review medical records and follow-up data from the prior 52 weeks to assess treatment changes, exacerbations, healthcare resource use, and lung function parameters. No extra diagnostic or therapeutic procedures will be performed beyond standard practice. The study will run from June 2024 to June 2027, aiming to provide detailed epidemiological insights into uncontrolled severe asthma in the Russian adult population.

Researchers are studying uncontrolled asthma in adults across Russia to better understand its characteristics and treatment patterns. This large-scale observational registry will include 9,000 patients from 70 outpatient centers in about 50 regions, focusing on those not receiving biologic therapy. The study aims to describe demographic and clinical features, capture complications and comorbidities, and evaluate routine therapies used in real practice. The study has an ambispective design with two main visits. At the first visit, physicians will collect baseline data from the past 52 weeks using medical records and patient interviews. The second visit, conducted 12 weeks later, will gather follow-up information on treatment changes and clinical outcomes. A subgroup of 500 patients using fixed-dose combination budesonidesalbutamol will have an additional third visit 12 weeks after the second to collect further data. Participants will undergo routine clinical assessments during 2 to 3 visits following standard practice. Researchers will examine demographic and clinical data, blood and sputum eosinophil counts, total IgE levels, asthma control status, lung function tests, exacerbation rates, and healthcare resource use. Safety monitoring aligns with routine care, and the study does not involve any experimental treatments or procedures. Total participation spans approximately 24 weeks for those in the extended follow-up group.

Researchers are actively monitoring the side effects of COVID-19 vaccines worldwide in healthcare workers, adults over 65, and schoolteachers. The study aims to estimate how common local and systemic side effects are for each vaccine brand, identify demographic and medical factors influencing side effects, and evaluate long-term consequences. It also compares the relative safety of different COVID-19 vaccines and examines how palliative drugs affect short-term side effect resolution. The project has two phases a cross-sectional survey and a prospective cohort study. Phase A uses an online questionnaire to collect information about short-term side effects occurring within 30 days after vaccination, covering either the first or second dose. Phase B follows volunteers interested in reporting long-term side effects and vaccine effectiveness after booster doses over five years, starting in 2022. Multiple COVID-19 vaccines are included, such as Pfizer-BioNTech, Moderna, AstraZeneca, Sinovac, Sinopharm, Sputnik V, Janssen, CureVac, Novavax, and Covaxin. Participants provide self-reported data through validated online questionnaires about side effect onset, duration, and intensity. The study tracks local and systemic side effects within 30 days post-vaccination as primary outcomes, with unrecognized side effects as secondary outcomes. Volunteers are followed for long-term safety and vaccine effectiveness, with a total observation period extending up to five years. This ongoing monitoring helps researchers understand vaccine safety profiles and side effect patterns in different populations.

Researchers are evaluating the effectiveness of adjuvant ribociclib combined with hormone therapy using aromatase inhibitors with or without GnRH agonists in patients with hormone receptor-positive HR HER2-negative stage II-III breast cancer. This observational study includes two groups a prospective cohort receiving ribociclib plus aromatase inhibitors, and a retrospective cohort treated with aromatase inhibitor monotherapy. The study aims to analyze outcomes based on tumor grade, lymph node involvement, and hormone therapy response in real-world clinical practice in Russia. Participants in the prospective group receive ribociclib along with aromatase inhibitors GnRH agonists, while the retrospective group includes patients treated with aromatase inhibitor monotherapy. Data collection includes both primary prospective data and secondary retrospective data from medical records. The study does not involve experimental treatment assignments but observes existing treatment patterns and outcomes. Participants will be monitored over several years with assessments at months 36, 48, and 60 to evaluate invasive breast cancer-free survival and other related outcomes. Quality of life questionnaires and safety data including adverse events are collected at multiple time points up to 60 months. The study involves continuous data review to assess treatment adherence, disease recurrence, and patient well-being throughout the observation period.

Researchers are investigating the use of a recombinant non-immunogenic staphylokinase Fortelyzin in patients who have experienced an acute ischemic stroke between 4.5 and 24 hours after symptom onset. This phase III, multicenter, double-blind, randomized, placebo-controlled trial aims to evaluate the efficacy and safety of this drug in restoring blood flow in patients with large vessel occlusion stroke who arrive outside the standard 4.5-hour treatment window. The study focuses on patients with salvageable brain tissue identified by advanced imaging techniques. Participants will be randomly assigned to receive either a single intravenous bolus injection of 10 mg non-immunogenic staphylokinase or a placebo administered rapidly within 5 to 10 seconds regardless of body weight. The trial excludes patients planned for direct thrombectomy. Following treatment, patients will be monitored for up to 90 days to assess outcomes. The trial evaluates functional recovery and reperfusion improvements compared to placebo. Throughout the study, participants will undergo imaging assessments such as CT or MRI perfusion scans to confirm eligibility and monitor brain tissue status. Researchers will evaluate functional outcomes using established stroke scales over 90 days, including the modified Rankin Scale and NIH Stroke Scale. Safety, mortality, and reperfusion rates will also be tracked. Participants will have follow-up visits and assessments designed to measure recovery and treatment impact over the trial period.

This research aims to study rickettsioses by identifying the genetic types of bacteria causing these infections in patients from regions of Russia. It is an observational, non-interventional study involving patients who have been diagnosed with or are suspected to have tick-borne rickettsioses. The study collects and analyzes biological samples to better understand the relationship between the bacterial types, patient symptoms, and disease progress. During the study, there is no change or influence on the patients routine treatment or diagnostic process, which follows standard medical care. Residual biological samples such as blood, plasma, buffy coat, serum, or swabs from skin lesions are collected and analyzed for rickettsial genotypes. Medical history, disease progression, symptoms, and treatments are recorded in individual case report forms. The study has received ethical approval and participants provide informed consent. Participants will have their medical history and symptoms documented, along with collection of leftover diagnostic samples. Researchers will perform genetic identification of the rickettsia species within approximately four weeks. The study monitors clinical patterns linked to specific bacterial types while maintaining regular care for patients. Participation involves data and sample collection only, with no experimental treatment. The study is expected to continue until the end of 2026.