Pickerington

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 the effectiveness of active surveillance and chemotherapy treatments in pediatric, adolescent, and adult patients with low risk and standard risk germ cell tumors. This phase III trial focuses on monitoring patients after tumor removal and comparing the outcomes of carboplatin-based versus cisplatin-based chemotherapy regimens. The study aims to maintain high overall survival rates for low risk patients and to compare event-free survival between the two chemotherapy options in standard risk patients. Additional objectives include assessing side effects such as hearing loss and neuropathy, and exploring tumor marker changes and other biological measures related to treatment outcomes. Patients with low risk stage I germ cell tumors undergo surgery followed by observation, with the option to transfer to standard risk treatment if the tumor recurs. Those with standard risk tumors are randomly assigned to one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin. Treatments are given intravenously on specific schedules every 21 days for up to 3 or 4 cycles, depending on the group. Throughout the trial, patients receive imaging scans, blood tests, tumor biopsies if needed, and pulmonary function tests to monitor treatment response and side effects. Participants are closely followed after treatment completion with regular visits every 2 months for the first year, then less frequently up to 10 years. Researchers collect data through imaging, blood samples, lung tests, and questionnaires to measure survival, disease recurrence, and side effects like hearing loss. The study also includes exploratory analyses of tumor markers and patient-reported outcomes to better understand treatment impacts and improve future care for germ cell tumor patients.

Researchers are investigating the addition of an immunotherapy drug called durvalumab to standard chemotherapy treatment in patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial aims to compare the effectiveness of usual chemotherapy alone versus chemotherapy combined with durvalumab. Immunotherapy with durvalumab may help the immune system attack cancer cells and prevent tumor growth and spread, while chemotherapy drugs like paclitaxel, doxorubicin, and cyclophosphamide work to stop cancer cells from growing or dividing. Previous studies suggest patients with an MP2 result might respond better to this combined treatment approach. Participants first undergo MammaPrint testing to confirm MP2 status before randomization into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide intravenously on day 1 every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously over 60 minutes on specified cycles during both chemotherapy phases. Mammography is performed during screening, and optional tissue and blood samples are collected for future studies. Throughout the study, participants are monitored through various assessments including imaging, physical exams, laboratory tests, and quality of life questionnaires focusing on fatigue and physical and mental health. Researchers track breast cancer event-free survival and other outcomes such as treatment side effects and response rates. After completing treatment, patients are followed for up to 10 years or until death to evaluate long-term outcomes and safety.

Researchers are evaluating the effects of adding cemiplimab, an immunotherapy drug that blocks the PD-1 pathway to help the immune system attack tumor cells, to the usual treatment of docetaxel and ramucirumab in patients with stage IV or recurrent non-small cell lung cancer. This phase II/III Expanded Lung-MAP trial compares cemiplimab combined with docetaxel and ramucirumab versus docetaxel and ramucirumab alone, aiming to improve treatment outcomes in patients who previously received platinum chemotherapy and immunotherapy but developed resistance or disease progression. Participants are randomly assigned to one of two treatment arms. In Arm I, patients receive dexamethasone orally twice daily on days 0-2, ramucirumab and docetaxel intravenously on day 1 of each 21-day cycle. In Arm II, patients receive the same treatments plus cemiplimab intravenously on day 1 of each cycle. Treatment cycles continue every 21 days until disease progression or unacceptable side effects occur. Throughout the study, patients undergo regular blood sample collection and imaging scans such as CT or MRI to monitor disease status. During the study, participants are closely monitored with scans, blood tests, and physical exams to assess overall survival and other outcomes like progression-free survival, response rates, and treatment safety. Researchers also collect blood samples for future molecular studies. After completing treatment, patients are followed up every 3 to 6 months for up to 3 years to track long-term survival and health status. The study measures overall survival from randomization to death from any cause, assessed up to 3 years.

Researchers are evaluating the use of NuShield4, a dehydrated placental allograft, in addition to the standard care compared to standard care alone for treating non-healing venous leg ulcers (VLUs). This prospective, multi-center, randomized controlled trial aims to gather outcome data to better understand the management of these ulcers, which are wounds on the legs caused by vein problems and have not healed with usual treatments. Participants will be assigned to receive either NuShield4 plus standard care or just standard care. The ulcers being treated must be located on the leg below the knee and above the ankle, and the treatment involves regular clinical visits. The study includes weekly visits to monitor the progress and response to the treatments over a period of up to 16 weeks. During the study, participants will attend weekly visits where researchers will assess wound healing and monitor safety. The main outcome measured is the proportion of subjects whose ulcers achieve complete closure by 16 weeks. Participants must comply with all study visits and procedures, and safety will be closely monitored throughout the trial to ensure participant well-being.

Researchers are evaluating the use of Electroencephalogram (EEG) based personalized Transcranial Magnetic Stimulation (eTMS) as a treatment for Post-Traumatic Stress Disorder (PTSD) in a randomized, sham-controlled study. The study focuses on United States Military veterans and first responders, such as firefighters, police, and paramedics, who have PTSD symptoms persisting for at least six months. The primary goal is to assess the safety and effectiveness of eTMS in reducing PTSD symptoms, measured by changes in the PTSD Checklist for DSM-5 (PCL-5) score over a period of 21 to 28 days. Participants will undergo an initial EEG recording to determine the best treatment settings for the eTMS device. Following this, they will attend 15 in-office visits over 21 to 28 days, with two eTMS treatment sessions at each visit. The study includes two groups: one receiving active EEG-based personalized TMS and a control group receiving sham TMS, which mimics the procedure but provides no actual stimulation. During the study, participants will be monitored closely with assessments including the PCL-5 questionnaire to measure PTSD symptoms before and after treatment. Researchers will also observe safety and side effects throughout the trial, which is expected to run for about 10 months from the first to the last participant enrolled. The study aims to recruit 110 participants, screening up to 800 individuals to meet this goal.

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 the safety of daily disposable MiSight 1 Day soft contact lenses in children aged 8 to 12 years with myopia. This post-approval study aims to confirm the safety of these lenses in the intended US patient population. Safety data from a previous MiSight 1 Day study will also be used to supplement this evaluation. Participants will wear MiSight 1 Day lenses daily for three years. The study focuses on children interested in wearing contact lenses for about 10 hours per day, 6 days per week. During this time, subjects will be monitored to assess the incidence of microbial keratitis and other safety outcomes. Throughout the study, children will undergo regular eye exams to check visual acuity and eye health, ensuring they remain free from infections or complications. Parent or guardian consent and assent from the child will be obtained, and medical records will be reviewed to track outcomes related to contact lens safety over the three-year period.

Researchers are investigating whether observation is as effective as continuing pembrolizumab treatment in patients with early-stage triple-negative breast cancer who achieved a complete response after preoperative chemotherapy combined with pembrolizumab. This phase III trial aims to evaluate recurrence-free survival and quality of life, as well as the value of reducing immunotherapy treatment after surgery in these patients. The study also examines differences in adverse events, overall survival, and financial impacts between treatment approaches. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group receives pembrolizumab intravenously as adjuvant therapy, while the other group undergoes observation without further treatment. Both groups have tumor biopsies and blood samples collected on study and during follow-up. Additional assessments include questionnaires and quality-of-life evaluations. During the study, researchers monitor participants for up to 10 years to measure recurrence-free survival. They assess quality of life using validated tools, track adverse events, and evaluate financial toxicity and work productivity. The study includes tumor tissue analysis, blood sample collection, and patient-reported outcomes to understand the long-term effects and value of treatment de-escalation in breast cancer care.

Researchers are evaluating targeted therapy directed by genetic testing for patients with locally advanced or advanced solid tumors that have spread to nearby tissues, lymph nodes, or other parts of the body. This research focuses on patients whose cancer has progressed despite standard treatments or for whom no standard treatment has been shown to improve survival. The trial aims to match patients to treatments based on specific genetic changes in their tumor cells, in hopes of controlling the tumor and improving treatment planning. This effort is part of the ComboMATCH program, a coordinated set of clinical trials designed to study combination therapies targeting molecularly defined patient groups. Patients undergo tumor mutational screening using previously collected samples, and those 18 years or older with disease suitable for biopsy may have a new tumor biopsy before starting treatment. Participants are assigned to one of multiple treatment subprotocols based on their tumor's genetic mutations. Treatments include various drugs taken orally, intravenously, or by injection, such as selumetinib, olaparib, fulvestrant, paclitaxel, and others, often in combination. Treatment cycles typically repeat every 28 days unless disease progression or unacceptable side effects occur. Some patients may be randomized to different treatment arms, and crossover to other arms is sometimes allowed. Procedures also include biopsies, blood collection, imaging scans (CT, MRI, PET), bone marrow aspiration, and heart function tests throughout the study. Participants are closely monitored with scans, biopsies, blood tests, and heart evaluations during treatment to assess response and safety. These assessments occur at various times, including screening, during treatment cycles, and follow-up periods that can last up to several years. Researchers measure patient enrollment rates, assignment to treatment arms, and outcomes within defined patient groups. The study also compares tumor genetic profiles from tissue and blood samples to better understand responses. Overall, the trial provides long-term observation of patients receiving personalized targeted therapies based on genetic testing results.