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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 18Years +MALE
26 locations
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Actively Recruiting

Researchers are evaluating the impact of a mobile application on treatment adherence in patients with stage II-III hormone receptor positive HR HER2-negative breast cancer. The study aims to see if using this app can help patients stick to their adjuvant therapy with ribociclib combined with an aromatase inhibitor AI by providing information on relapse risks and managing side effects. Participants include patients receiving adjuvant ribociclib plus AI therapy in routine clinical practice, divided into two groups those who use the web application and those who do not. The app is designed to support patients throughout their treatment, with observations made over 12 months and longer-term follow-up up to 36 months for user engagement and satisfaction. During the study, researchers will monitor the number of patients remaining on ribociclib plus AI treatment over 12 months. They will also assess app usage details such as session frequency and duration, patient and oncologist satisfaction, quality of life, treatment satisfaction, dose intensity, and adverse events. Data on patient demographics and tumor characteristics will be collected at baseline, with ongoing evaluations at multiple time points up to three years.

Age: 18Years - 90YearsAll Genders
7 locations
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Actively Recruiting

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.

Age: 18Years - 99YearsAll Genders
42 locations
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Actively Recruiting

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.

All Genders
24 locations