Khabarovsk

Researchers are conducting an observational multicenter cross-sectional study to better understand the characteristics of adults with uncontrolled severe asthma in Russia who are not receiving biological therapy. The study aims to collect detailed information on the epidemiology, clinical features, treatment patterns, and demographics of these patients across different regions of the Russian Federation, which vary widely in population composition and environmental factors. The study will help fill the gap in data about severe asthma in Russia, especially in patients treated according to standard care but excluding biologics. The study plans to include 5,000 adult patients from about 50 outpatient centers across 50 regions of Russia. It will collect routine clinical data without altering standard medical care or introducing any new diagnostic or therapeutic procedures. The study design includes one visit per patient to gather demographic, clinical, and treatment information, focusing on patients with uncontrolled severe asthma receiving standard treatments like inhaled corticosteroids with other medications but not biological agents. Participants will provide data through medical records and assessments such as the Asthma Control Questionnaire. Researchers will analyze patterns of drug use, clinical characteristics including comorbidities, blood counts, immunoglobulin levels, and lifestyle factors. The study will characterize patients' demographics, treatment trends, and asthma control status from June 2024 to June 2027. Safety monitoring is observational, with no intervention beyond routine care, and the total participation involves a single study visit.

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 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 conducting an observational surveillance study to identify the genetic types of rickettsia bacteria causing rickettsioses in patients from various regions of Russia. The study focuses on patients with diagnosed or suspected tick-borne rickettsioses. It aims to link genetic information of the bacteria with patients' medical histories, disease progression, symptoms, and treatments to find clinical patterns specific to different causative agents. The study is non-interventional and has received ethical committee approval. No changes are made to patients' routine treatment or diagnostic procedures during the study. Biological samples such as blood, plasma, buffy coat, serum, or eschar swabs collected during standard diagnostics are used for genetic analysis of the rickettsia species. These residual diagnostic samples are collected only after patients or their legal representatives give written informed consent. Physicians complete individual case report forms to record relevant medical information for each participant. Participants provide informed consent, and their medical history, symptoms, disease course, and treatments are recorded. The genetic typing of rickettsia bacteria is performed within up to 4 weeks after sample collection. The study monitors these genetic findings alongside clinical data to improve understanding of rickettsioses. There is no intervention or alteration in patient care, and the study respects current medical standards throughout its observation period.