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Found 2 Actively Recruiting clinical trials
Actively Recruiting
This research aims to evaluate the predictive value of other oncogene mutations on the effectiveness of anti-EGFR monoclonal antibodies in patients with unresectable metastatic colorectal cancer located on the left side of the colon. The study focuses on patients who have wild-type KRAS/NRAS/BRAF or wild-type KRAS/NRAS with unknown BRAF status and have not previously undergone systemic therapy for metastatic disease. It is a multicenter, randomized Phase III trial involving about 355 patients. Participants will be randomly assigned into two main groups: Cohort A, which receives combination chemotherapy with FOLFOX plus anti-EGFR therapy (panitumumab or cetuximab) based on their RAS/BRAF wild-type status, and Cohort BC, which starts FOLFOX chemotherapy along with molecular genetic profiling. The BC group is further divided based on their genetic profile into Cohort B, who receive anti-EGFR therapy plus chemotherapy, and Cohort C, who continue chemotherapy alone or receive bevacizumab if eligible. Treatment adjustments such as de-escalation to a modified chemotherapy regimen with cetuximab or panitumumab after 8 cycles are allowed. During the study, participants will undergo extensive molecular genetic testing, regular assessments of tumor response, and safety monitoring. The primary outcome measured is progression-free survival over an average of three years. Patients' blood counts, organ functions, and tumor material availability will be evaluated to ensure safety and eligibility. The study also includes follow-up to monitor treatment effectiveness and adverse effects throughout and after the treatment period.
Actively Recruiting
Researchers are evaluating the rate of chronic kidney disease (CKD) diagnosis in adults with arterial hypertension (AH) who have laboratory markers indicating possible CKD but no prior recorded CKD diagnosis. The study focuses on patients without diabetes mellitus or symptomatic chronic heart failure and aims to better understand CKD prevalence in this specific population in Russia. This multi-center, non-interventional, observational study includes both prospective and retrospective data analysis involving about 10,000 adult outpatients from approximately 50 outpatient sites across 20 regions of Russia. The study will not involve any new diagnostic or treatment procedures beyond routine clinical practice. Retrospective data will be collected from medical records to identify CKD markers measured within 12 months before study inclusion. Patients with adequate retrospective data may have CKD diagnosis confirmed based on two evaluations at least 3 months apart. Those without sufficient retrospective data will undergo laboratory testing during the prospective study period, which will last up to 18 months or until data from 10,000 patients are collected. Participants will be monitored and treated by cardiologists or internal medicine specialists during routine visits. Researchers will collect demographic and clinical information, including medical history and CKD markers, from both retrospective and prospective records. The main outcome is the rate of new CKD diagnoses over the 18-month follow-up. No additional interventions or procedures beyond usual care will be performed, and the study aims to support earlier CKD detection and improved clinical outcomes in patients with hypertension.