Scottsbluff

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the effectiveness of radiation therapy with or without the chemotherapy drug cisplatin in patients with stage III-IVA squamous cell carcinoma of the head and neck who have had surgery to remove their tumors. This phase II trial aims to understand if adding cisplatin to radiation therapy improves disease-free survival, especially considering the role of p53 mutations in the cancer cells. The study also investigates toxicities and potential genomic factors that might influence treatment outcomes. Patients are randomly assigned to one of two treatment groups. One group receives intensity-modulated radiation therapy (IMRT) alone once daily, five days a week for six weeks. The other group receives the same radiation treatment combined with weekly intravenous cisplatin over one to two hours, also for six weeks. Treatment continues as long as there is no disease progression or unacceptable side effects. During the study, participants undergo regular follow-ups every six months for three years and then yearly for seven more years to monitor for cancer recurrence or new tumors. Researchers assess disease-free survival, tracking the time from randomization until cancer returns, a second tumor develops, or death. Additional laboratory tests and biomarker analyses are performed to understand genetic changes and treatment effects. Safety and toxicities are closely monitored throughout the study period.