Saransk

This research investigates treatment patterns and the evaluation of homologous recombination repair mutations (HRRm) in circulating tumor DNA (ctDNA) among patients with aggressive high-volume metastatic hormone-sensitive prostate cancer (mHSPC) in the Russian Federation. The study focuses on patients with high-aggressive disease characterized by Gleason scores 8-10 and high-volume disease as defined by specific criteria for bone and visceral metastases. Approximately 400 male patients aged 18 years and older with known tumor HRRm status will participate to better understand demographic and clinical characteristics and treatment approaches in routine practice. The study does not introduce new treatments but observes and collects data as patients receive standard care. Two study visits will occur: the first at baseline to gather medical history, demographic data, and treatment information from diagnosis to enrollment, including routine blood samples for ctDNA and HRRm testing. The second visit will happen at disease progression or after about 12 months to collect follow-up data on progression to metastatic castration-resistant prostate cancer (mCRPC) and subsequent treatments. Blood samples will be analyzed centrally. Participants will have their medical records reviewed and may be interviewed to complete missing information. Data will be entered into electronic records by the study physician. Outcome measures include the proportion of patients receiving various treatments (such as androgen deprivation therapy, chemotherapy, radiation, surgery, and specific inhibitors), duration of therapies, time to progression, mutation presence in ctDNA, testosterone levels, and sites of disease progression over 36 months. Follow-up may be completed by phone if in-person visits are not possible, with the total study duration lasting about 38 months or until data from 400 patients are collected.

Researchers are evaluating the immunogenicity, reactogenicity, and safety of the drug GNG-DE compared to a reference drug for preventing meningococcal infections caused by serogroups A, C, W, and Y. This Phase 3 study includes participants aged 3 to 55 years and aims to assess how well GNG-DE stimulates an immune response and its safety profile versus the reference vaccine. Participants are divided into two groups: one group of 40 participants will receive a 0.5 mL dose of GNG-DE administered intramuscularly into the deltoid muscle, while the other group of 40 will receive a 0.5 mL dose of the Menactra® vaccine via the same method. Both treatments are given as single doses during the study. During the study, participants will be monitored for immune response by measuring primary immunogenicity parameters around Day 29. Safety and reactogenicity will also be assessed. Participants must attend scheduled visits, complete observation diaries, and comply with study requirements. The study includes screening tests such as SARS-CoV-2 antigen and pregnancy tests when applicable, and participants will be observed for any adverse reactions to the vaccines.

Researchers are evaluating the efficacy, safety, pharmacokinetics, and immune response to BCD-236 combined with chemotherapy in women with relapsed or metastatic triple negative breast cancer (TNBC). This Phase 2 study focuses on patients who have received at least one prior systemic therapy and whose cancer has progressed or relapsed. The study aims to better understand how this combination treatment works in later lines of therapy for this aggressive breast cancer subtype. Participants will receive BCD-236 as an intravenous infusion along with chemotherapy, which will be chosen at the investigator's discretion. The study compares this combination treatment's effects and monitors participants over time. The primary outcome measured is the overall response rate at 24 weeks after starting treatment, assessing how well tumors respond to the therapy. Throughout the study, participants will undergo tumor assessments using RECIST 1.1 criteria to measure treatment response. Eligibility requires confirmation of AXL expression in tumor cells from fresh or archival tumor samples. Patients will be monitored for safety and disease progression, with evaluations including physical exams and performance status assessments. The study includes women aged 18 to 74 years with adequate health to participate and a life expectancy of at least four months.

Researchers are conducting a multicenter, double-blind, placebo-controlled, randomized clinical trial to study children aged 3 to 12 years with acute respiratory viral infection (ARVI) symptoms within 24 hours of onset. The trial aims to evaluate the efficacy and safety of Raphamin compared to a placebo in treating ARVI. Enrollment will begin with children aged 6 to 12 years, followed by an interim analysis to decide whether to include younger children aged 3 to 5 years. Patients will be outpatients of either gender during seasonal ARVI incidence. Participants will be randomly assigned to receive either Raphamin tablets or placebo tablets for 5 days. Treatment groups follow the same dosage regimen. Before starting therapy, nasopharyngeal swabs will confirm viral infection through PCR testing. Throughout the trial, an electronic patient diary will be used to record temperature, symptoms, antipyretic use, and any worsening condition. The study includes screening, randomization, treatment, and follow-up periods lasting a total of 14 days. During the study, patients will attend three visits on days 1, 5, and 7, either at a health center or home, plus a phone visit on day 14. At visits, physicians will assess symptom severity, perform examinations, monitor diary completion, and conduct lab tests. The main outcome measured is the time needed for ARVI symptoms to resolve within 14 days. Safety and compliance will be closely monitored, and symptomatic or concomitant therapies are allowed except for prohibited drugs.

Researchers are conducting a multi-center, non-interventional study to observe routine diagnostic and treatment practices for patients with unresectable or inoperable locally advanced non-small cell lung cancer (NSCLC) and limited-stage small cell lung cancer (LS-SCLC) in 50 major oncology centers across Russia. The study will collect data from 2000 patients receiving chemo-radiation therapy (CRT) over two years. The aim is to understand demographic and clinical characteristics, diagnostic procedures, treatment approaches, and short-term outcomes of CRT in these patients, without collecting information on treatments following CRT such as durvalumab. The study involves collecting data at two main points: at the start of CRT (either concurrent or sequential chemo-radiation) and after the last dose of radiation therapy, including results from computed tomography (CT) scans. Data collection will be done from patients' medical records in routine clinical practice, and the second data collection is expected to occur within six months after the first visit. The study follows local regulations for adverse event reporting and does not involve additional interventions or treatments. Participants will be adults aged 18 years or older who have locally advanced NSCLC or LS-SCLC and are currently undergoing radiation therapy as part of CRT. Researchers will gather information on patient demographics, disease stage, histology, and clinical status at baseline. The study will monitor treatment details and short-term outcomes after CRT. All data is collected from existing medical records, ensuring no extra procedures for participants. The total participation duration aligns with routine treatment schedules and follow-up visits.

Researchers are evaluating the efficacy and safety of a liquid form of Rengalin for treating cough in children aged 6 months to 3 years who have acute viral upper respiratory infections during flu and ARVI outbreaks. This Phase 3 clinical trial compares Rengalin with a placebo to see if it effectively reduces cough severity in young children with dry or non-productive cough lasting between 24 and 72 hours. Participants will be randomly assigned to receive either Rengalin or a placebo, both given orally as 5 ml doses three times a day for 7 days. The study includes several visits: at the start (Day 1), at Day 4 for evaluation and potential addition of mucolytic therapy if needed, and at Day 8 for further assessment and sample collection. Parents will use an electronic diary to record their child's cough severity twice daily throughout the treatment period. During the study, doctors will monitor the child's condition, check for complications, and assess safety through physical exams, laboratory tests, and questionnaires. Follow-up continues up to 14 days, including a phone interview to evaluate recovery and any complications. The main result measured is the percentage of children who respond to the treatment by Day 3 compared to their baseline cough severity.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.

Researchers are evaluating the effectiveness of adjuvant ribociclib combined with hormone therapy (aromatase inhibitors with or without GnRH agonists) in patients with hormone receptor-positive, HER2-negative stage II-III breast cancer in Russia. The study includes both a prospective cohort receiving ribociclib plus hormone therapy and a retrospective cohort treated with hormone therapy alone. The goal is to assess treatment outcomes in different patient subgroups defined by tumor grade, lymph node involvement, and hormone therapy response. Participants in the prospective group receive ribociclib alongside aromatase inhibitors, with or without GnRH agonists, as part of their adjuvant therapy. The retrospective group includes patients treated with aromatase inhibitors alone during a specific period from July 2019 to July 2020. The study collects new data from the prospective group while also analyzing existing patient records from the retrospective group. Throughout the study, researchers monitor invasive breast cancer-free survival at 36, 48, and 60 months following treatment according to standardized criteria. Patient information is gathered from clinical records, including hormone therapy start dates and treatment responses. Safety and effectiveness are assessed by tracking outcomes over several years to better understand ribociclib's role in routine clinical practice for this type of breast cancer.

Researchers are evaluating the efficacy, safety, and tolerability of Ingavirin forte capsules administered at different doses compared to Ingavirin, 90 mg capsules, in adults aged 18 to 65 years who have influenza or other acute respiratory viral infections confirmed by PCR. This phase 2 study aims to understand how these treatments affect symptom resolution in these viral infections. Participants receive one of the following treatments: Ingavirin Forte capsules at doses of 90 mg plus either 5 mg, 10 mg, or 20 mg, or Ingavirin 90 mg capsules, or placebo. Each regimen involves taking one capsule twice daily for 5 days. The study is randomized, double-blind, and placebo-controlled to compare the effects of these different doses and formulations. During the study, participants are monitored from Day 1 to Day 10 for the time it takes from the first dose until all symptoms resolve and remain absent for at least 24 hours without the use of NSAIDs or decongestants. Assessments include clinical evaluation of influenza symptoms, monitoring safety and tolerability, and ensuring adherence to the dosing schedule. The total participation period covers symptom resolution and treatment follow-up.

Researchers are conducting a multicenter observational study in the Russian Federation to examine treatment approaches, patient characteristics, and biomarker prevalence in men with newly diagnosed high-aggressive metastatic hormone-sensitive prostate cancer (mHSPC). The study focuses on patients with Gleason scores between 8 and 10 who were diagnosed within two years before enrollment. It aims to collect information on demographic and clinical features, treatment methods, and biomarker status, including PTEN loss, HER2-positive status, HRR mutations, and HRD positivity. Participants will not receive any additional procedures beyond their routine clinical care. Data will be collected during a single visit and include medical history, treatment received, and outcomes. Tumor tissue samples taken during standard care will be tested centrally for biomarkers using immunohistochemistry and next-generation sequencing. Approximately 400 patients across around 30 sites will be enrolled over about 27 months or until the target number is reached. During the study visit, researchers will gather information from medical records and patient interviews, entering data into an electronic case report form. No follow-up visits are planned. Key outcomes measured include the types and proportions of treatments patients have received over 24 months, such as hormone therapy, chemotherapy, radiation, surgery, and combination therapies, as well as biomarker test results. The study duration includes enrollment and data collection until database lock.