Buena Park

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

Researchers are evaluating treatments for patients with metastatic kidney cancer to see if adding surgery to standard immunotherapy-based drug combinations improves outcomes. This phase III trial focuses on kidney cancer that has spread to other parts of the body. The study compares standard immunotherapy drugs, which help the immune system fight cancer, with or without the surgical removal of the kidney, known as nephrectomy. Doctors currently do not agree on whether surgery adds benefit when combined with these immunotherapy treatments. Participants first receive one of three immunotherapy-based drug regimens, including combinations of nivolumab, ipilimumab, pembrolizumab, avelumab, and axitinib, given through intravenous infusions and oral tablets over several weeks. After 10-14 weeks of this initial treatment, patients are randomly assigned to either continue immunotherapy drugs alone or to also have kidney surgery followed by the same drugs. Surgery may be done by different methods and must occur within 8 weeks of randomization. Axitinib is stopped at least 24 hours before surgery. During the study, participants undergo regular scans of the chest, abdomen, and pelvis to assess disease status. They are monitored for survival for up to 7 years after randomization, with follow-up visits every 3 months in the first year, then every 6 months for two years, and annually thereafter. Researchers also evaluate tumor response, surgical complications, and drug side effects. Specimens are collected for future research, and participants' health and treatment effects are closely followed throughout the study period.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

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 safety and effectiveness of lumateperone in treating irritability associated with Autism Spectrum Disorder (ASD) in children and adolescents aged 5 to 17 years. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study includes participants diagnosed with ASD and confirmed irritability symptoms using standard diagnostic tools. The study consists of three phases: a screening period lasting up to 14 days to check eligibility, a 6-week double-blind treatment period where participants will be randomly assigned to receive either a high dose of lumateperone, a low dose of lumateperone, or a placebo once daily, and a 1-week safety follow-up period after the last dose to monitor participants' well-being. During the study, participants will be monitored for changes in irritability using the Aberrant Behavior Checklist - Irritability subscale at week 6. Safety evaluations will occur during the follow-up visit approximately one week post-treatment. Throughout the trial, assessments will include clinical evaluations and caregiver reports to track symptoms and any side effects, ensuring participant safety over the approximately seven-week participation period.

Researchers are evaluating a phase II trial to see if adding TRC102 (methoxyamine hydrochloride) to the usual treatment of chemotherapy and radiation followed by durvalumab works better to shrink tumors in patients with stage III non-squamous non-small cell lung cancer (NSCLC). TRC102 is an anti-cancer drug that blocks tumor cells from repairing DNA damage, potentially making other cancer drugs more effective. The trial aims to improve progression-free survival at one year compared to the current standard treatment. Participants are randomly assigned to one of two groups. One group receives TRC102 orally on day 1, pemetrexed intravenously on day 1, and cisplatin or carboplatin intravenously on day 3, along with daily radiation therapy Monday through Friday for two cycles every 21 days. After 2 to 6 weeks, they receive durvalumab intravenously every 2 weeks or monthly for up to one year. The other group receives the same chemotherapy and radiation schedule without TRC102, followed by the same durvalumab treatment. Imaging scans such as CT, MRI, and FDG-PET/CT are done during the study and screening. During the study, participants undergo regular imaging and laboratory tests to monitor tumor progression and treatment safety. They are followed for up to five years with visits at 30 days after treatment, every 3 months for 2 years, then every 6 months for an additional 3 years. Researchers measure progression-free survival, overall survival, and monitor side effects like pneumonitis. The total participation time allows tracking tumor stability and long-term effects of the treatments.

Researchers are evaluating the addition of BMX-001, a drug that neutralizes harmful substances and reduces tissue damage, to the usual symptom management for patients receiving chemoradiation for head and neck cancer. This phase II trial aims to compare the incidence and duration of severe oral mucositis, a painful inflammation and sores in the mouth, between patients treated with BMX-001 and those receiving a placebo. The study also assesses other side effects like dry mouth and skin reactions, overall survival, progression-free survival, pain reduction, and collects blood samples for future research. Participants are randomly assigned to one of two groups. Both groups receive standard cisplatin chemotherapy either weekly or every three weeks and undergo image-guided intensity-modulated radiation therapy daily for seven weeks. One group receives BMX-001 injections under the skin starting before radiation and cisplatin, continuing twice weekly for eight weeks, while the other group receives placebo injections on the same schedule. Patients may have CT or MRI scans during the study and can optionally provide blood, serum, and plasma samples. During the study, patients are monitored from the start of radiation through four weeks after treatment to track severe oral mucositis and other side effects. Additional assessments occur at 6, 8, and 12 weeks post-treatment. Follow-up visits continue at 1, 2, 3, 6, 12, and 24 months to observe long-term outcomes. Researchers use questionnaires, clinical evaluations, and lab tests to measure symptoms, toxicity, and treatment effects throughout the study.

Researchers are evaluating the effect of chemotherapy with capecitabine and temozolomide after surgery in patients with high-risk well-differentiated pancreatic neuroendocrine tumors. This phase II trial aims to see whether giving these chemotherapy drugs after tumor removal can prevent or delay the return of cancer compared to just observation. The study also looks at overall survival, safety, and collects tissue samples for future research. Participants are randomly assigned to one of two groups. One group receives capecitabine orally twice daily on days 1-14 and temozolomide orally once daily on days 10-14, repeated every 28 days for up to four cycles if there is no disease progression or unacceptable side effects. The other group is monitored without active treatment. After treatment or observation, all patients are followed up every six months for three years and then yearly up to five years from randomization. During the study, participants undergo regular scans to check for cancer recurrence and have blood tests to monitor their health and treatment effects. Researchers review medical history, physical exams, and laboratory tests before and during the study. The main outcome measured is recurrence-free survival over five years. Safety and tolerability of the chemotherapy are also tracked throughout the study period.