Rockville Centre

Researchers are creating a registry to study people with early changes in the stomach lining that may lead to gastric cancer. This includes those with gastric atrophy, intestinal metaplasia, and dysplasia. The study also enrolls healthy individuals and people with gastric cancer to compare baseline characteristics and better understand risk factors for disease progression. Participants fall into three groups those with specific stomach lesions, healthy controls, and people with gastric cancer. The study collects information through questionnaires about clinical history, environmental exposures, lifestyle, and diet. This observational study does not involve any treatment but gathers health data to support future research. Participants will complete questionnaires and provide health information over a period that may last up to 10 years. The main goal is to build a detailed participant registry. Researchers will monitor and analyze the collected data to identify factors related to the progression of stomach lesions to cancer. Participation involves regular data collection but no active treatment, with safety and privacy monitored throughout the study.

Researchers are studying the long-term quality of life outcomes in patients with lymphedema who either choose to have surgery using vascularized lymph node transfer VLNT or opt for non-surgical management. The study aims to compare these two groups to better understand the impact of surgical versus non-surgical treatment on patient well-being. This observational study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on adults with primary or secondary lymphedema affecting the upper or lower limbs. Participants are divided into two groups based on their treatment choice those who undergo VLNT surgery and those who receive non-surgical care. There is no additional treatment or intervention during the study follow-up period the research simply observes and assesses quality of life over time. The study uses established questionnaires such as the Upper Limb Lymphedema ULL-27, Lymphedema Life Impact Scale version 2 LLISv2, and LYMQOL-Leg to evaluate patient outcomes. During the study, participants complete quality of life assessments up to 40 months after enrollment. There are no therapeutic procedures administered as part of the study itself. The research team monitors patient responses to these questionnaires to measure the impact of different treatment choices on daily living and overall health. The study includes adults between 18 and 80 years old who speak English and meet specific lymphedema stage criteria.

Researchers are evaluating whether combining the biological agent 2141-V11 with various standard treatments can be an effective approach for treating prostate cancer. This study focuses on men with clinically localized or locoregional high-risk disease, as well as those with low-volume metastatic disease where removing the primary tumor combined with other treatments might eliminate all cancer cells. The treatment works by activating the immune system to target and kill cancer cells, with researchers monitoring for complete cancer response and minimal residual disease MRD, which is a small number of cancer cells that may remain after treatment. Participants will receive intratumoral injections of the anti-CD40 agonist antibody 2141-V11. For men with intermediate risk disease, the antibody is given before radical prostatectomy, while those with high-risk localized or low-volume metastatic disease will receive the antibody in combination with androgen deprivation therapy. The study is non-randomized and involves single-site injections of 2141-V11 as monotherapy or combined with standard therapies, depending on the disease stage. During the study, participants will undergo clinical assessments including prostate MRI scans and staging evaluations. Researchers will monitor participants over 24 months to measure the number who achieve complete response or have minimal residual disease. Safety and treatment effects will be closely observed through laboratory tests, physical exams, and documentation of any side effects. Participants adherence to birth control requirements and other safety measures will also be monitored throughout the study period.

This study is exploring whether it is practical to conduct a larger trial evaluating the Breast Reconstruction Decision Aid Tool RECONJOINT for people considering breast reconstruction surgery after mastectomy. It aims to assess the feasibility of using this decision aid to support patients in making informed choices about reconstruction. The study involves participants with breast cancer or genetic predisposition to breast cancer who are considering post-mastectomy reconstruction. Participants are assigned to either usual care or to receive RECONJOINT along with enhanced usual care. Surgeons are randomized to either provide enhanced usual care or the intervention using RECONJOINT in a parallel design. Those in the intervention arm receive the decision aid to help guide their breast reconstruction decisions before surgery. Participants will be involved from their initial reconstructive surgery consultation through surgery. Researchers will track how many patients join within 60 days after the consult and before surgery to determine feasibility. The study is sponsored by Memorial Sloan Kettering Cancer Center and includes monitoring participant accrual as a primary outcome. The total study period extends to early 2029.

Researchers are evaluating a new total-body PET scanner called the Biograph Vision Quadra to see if it can produce better PETCT images and provide more detailed imaging information compared to standard PETCT scanners. This study focuses on adults with lung, head and neck, or prostate cancer who are undergoing routine or clinical trial PETCT scans. Participants will undergo one or two additional PETCT scans using the Biograph Vision Quadra scanner during their scheduled imaging sessions. These extra scans may include breath-hold, dynamic, or delayed image acquisitions. The study collects additional imaging data from patients already scheduled for PETCT as part of their standard care or ongoing clinical trials. During the study, participants will have standard PETCT scans along with the additional scans from the new scanner. Researchers will assess image quality over a three-year period. Participants may be asked to return for late imaging sessions several hours after the radiotracer injection. The study involves no investigational treatments, focusing on imaging data collection and quality improvement, with the total participation duration depending on scheduling and imaging needs.

Researchers are evaluating a navigation program designed to help people with kidney, bladder, breast, or lung cancer better manage the side effects of immunotherapy treatment. The study aims to compare this navigation program to usual care and to understand its impact on participants quality of life. Quality of life will be measured through questionnaires completed by participants. Participants will be randomly assigned to either the Immunotherapy CARE Program or to enhanced usual and customary care and support. Those in the CARE Program will receive monthly assistance from staff in managing essential needs and reporting side effects or symptoms. The study is interventional and uses a parallel design to compare these two groups. During the study, participants will complete questionnaires to assess their quality of life and will be monitored for continuation of immune checkpoint inhibitor therapy over six months. The study involves regular contact for navigation support and data collection, with researchers tracking treatment adherence and side effects. Participation is expected to last until the primary outcome measurement at six months.

Researchers are evaluating different doses of abemaciclib combined with hormone therapy and radiation therapy in people diagnosed with metastatic hormone receptor-positive HR, HER2-negative breast cancer. This Phase I study aims to find the maximum tolerated dose of abemaciclib when given alongside radiation therapy to bone metastases, helping to identify the best dose for future treatments. Participants will receive abemaciclib orally every 12 hours starting on the day of radiation therapy simulation through the end of radiotherapy, which lasts up to 28 days. Radiation therapy is given as either 27 Gy in 3 daily fractions or 30 Gy in 5 daily fractions, all completed within 28 days. After determining the maximum tolerated dose, additional patients needing bone metastases palliation will be enrolled for further evaluation. During the study, participants will undergo regular assessments to monitor tolerability and side effects over a period of up to one year. Researchers will track the maximum tolerated dose of abemaciclib and evaluate patient recovery from prior treatments. Participants must have adequate organ function and be able to swallow oral medications. Safety monitoring and adherence to treatment schedules will be part of the study procedures throughout the trial duration.

Researchers are evaluating a tailored anxiety treatment program designed for Latino older adults with cancer and their caregivers. The study aims to understand if this intervention is practical and effective in addressing anxiety in this specific population. This research is sponsored by Memorial Sloan Kettering Cancer Center and focuses on participants who are actively undergoing or recently completed cancer treatment. The treatment being studied is called Managing Anxiety from Cancer MAC, a seven-session psychotherapy program delivered through videoconference or telephone by licensed social workers or advanced mental health trainees. Each session lasts 45 to 60 minutes and is based on cognitive behavioral therapy principles. Sessions are audio-recorded to maintain quality and consistency. Participants will complete all study procedures over the course of one year, with researchers monitoring the percentage of participants who complete the entire program. Evaluations include assessments of anxiety levels and participants engagement with the treatment. The study also tracks safety and adherence, with follow-ups to understand the interventions impact on anxiety management among Latino older adults with cancer and their caregivers.

Researchers are evaluating whether Stimulan Rapid Cure can reduce infections in people undergoing tissue expander placement during mastectomy for breast cancer or related preventive reasons. The study also examines if this antibiotic delivery affects the risk of seroma, a complication involving fluid buildup after surgery. This is a randomized, phase 4 clinical trial assessing the prevention of breast tissue expander-associated infections. Participants are assigned to one of two groups one receives tissue expanders with antibiotic beads containing vancomycin and gentamicin delivered through Stimulan Rapid Cure during surgery, and the other receives tissue expanders alone. The study compares infection and seroma rates within 90 days after surgery to evaluate the effectiveness of the antibiotic delivery device. During the trial, participants will undergo mastectomy with immediate breast reconstruction using prepectoral tissue expanders at Memorial Sloan Kettering Cancer Center. Researchers will monitor surgical site infections and seroma formation for 90 days postoperatively. The study involves regular follow-up to assess these outcomes and ensure participant safety throughout the trial period.

Researchers are evaluating the combination of avutometinib and defactinib as a treatment for patients with RAF dimer-driven radioiodine-refractory differentiated thyroid cancer or anaplastic thyroid cancer. This phase II study aims to assess whether this combination is effective and safe, causing few or mild side effects. The trial is sponsored by Memorial Sloan Kettering Cancer Center and funded by the FDA Office of Orphan Products Development. Participants receive avutometinib at 3.2 mg twice weekly and defactinib at 200 mg twice daily, both given in cycles of 3 weeks on treatment followed by 1 week off. There are two patient groups one with radioiodine-refractory, recurrent or metastatic differentiated thyroid cancer, and the other with anaplastic thyroid cancer. Both groups are treated similarly with this drug combination throughout the study period. During the study, participants undergo assessments to measure tumor response using the overall response rate over up to two years. They will have biopsies and provide tumor tissue for correlative studies. Safety and side effects are monitored, including heart function tests and laboratory evaluations. The total study duration for each participant can last up to two years, with regular visits for treatment and evaluation.