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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.
Actively Recruiting
Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication LSS with NC in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression IPD. The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the studys NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.
Actively Recruiting
Researchers are evaluating the effectiveness of radiation therapy with or without the chemotherapy drug cisplatin in treating patients who have stage III-IVA squamous cell carcinoma of the head and neck and have undergone surgery. This phase II trial aims to understand how well these treatments work, focusing on disease-free survival and the role of p53 gene mutations in predicting patient outcomes. The study also examines treatment side effects and explores genetic changes that could guide new therapies. Participants are randomly assigned to one of two treatment groups. One group receives intensity-modulated radiation therapy IMRT once daily, five days a week for six weeks. The other group receives the same radiation schedule combined with weekly intravenous cisplatin over 1-2 hours for six weeks. After treatment, patients will be followed up every six months for three years and then annually for seven more years to monitor their health status and disease progression. Throughout the study, participants undergo various assessments including surgical tissue analysis for p53 mutations, imaging tests to check for disease spread, and regular evaluations of treatment side effects. Researchers measure disease-free survival, tracking the time until cancer recurrence, new tumors in the head and neck region, or death for up to ten years. Safety is monitored closely during treatment, with adverse events recorded up to six weeks after therapy. The total participation duration can extend up to ten years due to long-term follow-up.