Englewood

Researchers are evaluating the safety of OviTex PRS, a reinforced tissue matrix used in implant-based breast reconstruction surgeries, in women aged 18 to 75 years. This observational study looks at patients who previously received either permanent or resorbable OviTex PRS devices during immediate or two-stage unilateral or bilateral breast reconstructions, placed either above or below the chest muscle. The goal is to understand the safety profile of these devices and help guide future studies on their effectiveness. Participants in the study had undergone breast reconstruction surgery using OviTex PRS combined with implants, either permanent or resorbable types. The procedures included initial surgeries and any necessary exchange surgeries. The study collects data retrospectively and prospectively across multiple centers to assess outcomes related to the use of these devices. During the study, researchers track any significant adverse events within 24 months after implantation of the OviTex PRS device. Participants may be asked to return for follow-up visits, including photographic documentation. The study focuses on monitoring safety outcomes over two years, ensuring patients' recovery and device performance are carefully observed.

Researchers are evaluating the effectiveness and safety of targeted treatments with or without the immune therapy drug atezolizumab in women with recurrent or persistent endometrial cancer. This Phase IB/II multi-cohort study uses genomic screening to assign participants to groups based on their tumor's specific genetic profile, aiming to match them with targeted therapies. The study allows for new treatment groups to be added over time with committee approval. Participants receive treatments depending on their assigned group. Those in the AFT-50A Protocol receive combinations of atezolizumab with targeted drugs such as talazoparib, while the AFT-50B Protocol includes combinations of targeted agents like inavolisib with letrozole or giredestrant with abemaciclib. Treatments are given in cycles, mostly every 21 or 28 days, with drug delivery methods including intravenous infusions and oral tablets. Some treatment groups have closed to enrollment, while others are open and each group has a planned number of participants. During the study, participants undergo tumor biomarker testing before assignment and regular assessments to monitor treatment response and safety. Researchers measure the overall response rate and track how many participants survive without disease progression at six months. Close monitoring includes imaging and clinical evaluations over a period extending up to 48 months. This comprehensive approach helps to understand how these targeted and immune therapies work in this patient group.

Researchers are evaluating the effects of Viv, a dietary supplement made from Magnolia officinalis bark extract, on immune system markers in adults with psoriasis. This trial compares Viv to a placebo to see if it influences biomarkers related to immune activity. The study focuses on adults who have had stable psoriasis for at least six months, including those with certain related conditions such as psoriatic arthritis. Participants will take either Viv or a placebo capsule daily for three months. Viv capsules contain 200mg of Magnolia officinalis bark extract, while the placebo capsules contain no active ingredients but look identical. Throughout the study, participants will use electronic questionnaires to report their quality of life and psoriasis symptoms at the start, one month, and three months. Blood samples will be collected at these same times using home collection kits. Participants will collect and send blood samples to measure specific inflammatory proteins, including plasma Beta defensin 2 levels, to see how they change during the study. Researchers will monitor these biomarkers to assess immune activation. The study requires participants to use a smartphone app for data collection and to adhere to the study procedures over the three-month period. Safety and compliance will be tracked remotely throughout the trial.

Researchers are evaluating the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab in patients with advanced or locally unresectable stomach or esophageal adenocarcinoma. This phase II/III trial aims to determine if adding nivolumab improves progression-free survival and overall survival compared to paclitaxel and ramucirumab alone. The study also assesses response rates, disease control, safety, tolerability, and quality of life in participants with PD-L1 CPS 21 1 advanced gastric or esophageal cancer. Participants are randomly assigned to one of two treatment groups. The first group receives nivolumab IV on day 1 of each 28-day cycle, ramucirumab IV on days 1 and 15, and paclitaxel IV on days 1, 8, and 15. The second group receives ramucirumab IV on days 1 and 15 and paclitaxel IV on days 1, 8, and 15 of each cycle. Treatment continues every 28 days until disease progression or unacceptable side effects occur. Optional blood samples may be collected during the study. Imaging with CT and MRI is performed throughout. Participants undergo scans and assessments at baseline and during treatment to monitor cancer progression and treatment effects. They also complete questionnaires on quality of life and symptoms. After treatment ends, participants are followed up at 30, 60, and 90 days and then every 6 months for up to 3 years. Researchers measure progression-free survival and overall survival as primary outcomes, along with other safety and patient-reported measures.

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are comparing two approaches of standard therapy for patients with stage II to IIIB non-small cell lung cancer (NSCLC) that can be surgically removed. This phase III trial evaluates whether giving chemotherapy and immunotherapy before and after surgery (perioperative) is more effective than giving the same treatments only after surgery (adjuvant). The study aims to find out which method leads to better event-free survival and overall survival over several years. Participants are randomly assigned to one of two groups. In the adjuvant group, patients have surgery first, followed by up to four cycles of platinum-based chemotherapy and up to one year of immune checkpoint inhibitor treatment if there is no disease progression or unacceptable side effects. In the perioperative group, patients receive chemotherapy combined with immune checkpoint inhibitors before surgery, then have surgery, and continue immune checkpoint inhibitor therapy for up to one year afterward. Chemotherapy drugs used may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, or vinorelbine, and immunotherapy drugs may include nivolumab, pembrolizumab, or atezolizumab. During the study, patients undergo imaging tests such as CT scans, MRI, or PET/CT scans to monitor their condition. After completing treatment, they are followed for up to 10 years with check-ups every six months. Researchers measure event-free survival at three years, overall survival up to 10 years, surgical outcomes, side effects, and other treatment-related factors to understand which approach offers better results for patients with resectable NSCLC.

Researchers are evaluating the effects of using multiple arterial grafts (MAG) versus a single arterial graft (SAG) in women undergoing coronary artery bypass grafting (CABG). This international, multi-center randomized trial named ROMA:Women aims to determine whether MAG improves major heart and brain-related events and quality of life compared to SAG. The study includes 2,300 women to examine outcomes like death, stroke, heart attacks, repeat surgeries, and hospital stays, along with quality of life and mental and physical health symptoms in a subgroup of 500 participants. Important patient subgroups such as age, diabetes status, race, surgical techniques, and type of arterial grafts will also be analyzed. Participants will be randomly assigned to receive either single arterial grafting, where the left internal thoracic artery is connected to the heart's left anterior descending artery along with venous grafts, or multiple arterial grafting, where an additional arterial graft such as the right internal thoracic artery or radial artery is used for other coronary branches, plus other grafts as needed. The trial leverages existing infrastructure and continues enrollment with additional sites to reach its target sample size. Both treatment arms follow the same randomization, interventions, and follow-up protocols as the parent ROMA trial. During the study, researchers will monitor participants for at least 2.5 years after surgery to track major cardiac and cerebrovascular events and assess disease-specific and generic quality of life measures using questionnaires such as the Seattle Angina Questionnaire and PROMIS-29. The trial will collect data through clinical assessments and questionnaires to evaluate health outcomes and symptom changes. Safety and effectiveness will be closely followed to understand the impact of the two grafting methods in women undergoing CABG.

Researchers are evaluating if active surveillance combined with hormonal therapy can effectively manage ductal carcinoma in situ (DCIS), an early stage of breast cancer. This phase 2 trial aims to find out whether new endocrine therapies can increase the number of patients who can safely remain on long-term active surveillance, avoiding surgery and radiation that carry significant health effects. Participants will receive either one of three investigational hormonal treatments (z-Elacestrant, Testosterone plus Anastrazole, or Z-endoxifen) or control hormonal therapy (Tamoxifen or an aromatase inhibitor) based on random assignment. They will take the assigned medication orally or by injection according to specified doses and schedules, with treatment lasting up to 36 months. MRI evaluations will be done at 3 and 6 months to assess disease status and decide whether to continue treatment or recommend surgery. Follow-up mammograms and MRIs will occur every 6 months thereafter. During the study, participants will provide blood and saliva samples for immune and genetic testing. If surgery becomes necessary, tissue samples from the procedure will be collected for research. Participants will be closely monitored through imaging and clinical assessments and followed annually for 10 years to observe long-term outcomes. The main outcome is the number of patients who remain on active surveillance at 7 months.