Rockville Centre

Researchers are collecting health information to understand and prevent gastric cancer by studying people with precursor lesions like gastric atrophy, intestinal metaplasia, and dysplasia. The study will also include healthy individuals and patients with gastric cancer to compare baseline characteristics. The goal is to create a long-term registry of participants to learn more about the progression of these conditions over up to 10 years. Participants will complete a detailed questionnaire covering clinical history, environmental exposures, lifestyle habits, and diet. This behavioral intervention helps gather important risk factor data related to gastric cancer and its precursors. The study includes people diagnosed with precursor lesions or early gastric cancer treated endoscopically, healthy controls undergoing endoscopy for other reasons, and patients with early gastric adenocarcinoma undergoing surgery. During the study, participants will provide health information and undergo endoscopies as clinically indicated. Researchers will monitor and record data to build the participant registry, which will be maintained for up to 10 years. This will allow long-term follow-up and comparison across different groups to better understand risk factors and progression toward gastric cancer.

Researchers are evaluating two types of PET/CT scans to determine which is more effective for detecting and monitoring metastatic invasive lobular carcinoma (ILC), a subtype of breast cancer. The study compares fluorine 18 (18F)-fluoroestradiol (FES) PET/CT scans with the standard 18F-fluorodeoxyglucose (FDG) PET/CT scans in patients with metastatic ILC that is estrogen receptor positive (ER+) and HER2-negative. The goal is to improve imaging methods for better assessment of this breast cancer type. Participants will undergo FES PET/CT scans at the start of the study and again shortly after treatment, within two weeks of a restaging FDG PET/CT scan. The comparison of these imaging techniques will help researchers understand their effectiveness in monitoring treatment response and disease progression in metastatic lobular breast carcinoma. During the study, patients will be monitored over a one-year period with baseline imaging and follow-ups. Researchers will collect data on the accuracy of each scan type in detecting cancer spread and response to therapy. This includes comparing FES PET/CT results to the standard FDG PET/CT scans. Participant health status and safety will be assessed throughout the study, focusing on imaging outcomes and treatment responses.

Researchers are studying long-term outcomes in patients with lymphedema who choose surgery involving vascularized lymph node transfer compared to those who opt for non-surgical management. The goal is to evaluate differences in quality of life over time between these two groups. The study includes adults aged 18 to 80 years with primary or secondary lymphedema of the upper or lower limbs, across various stages of the condition. Participants are divided into two groups: those undergoing surgical treatment and those receiving non-surgical management. Quality of life is assessed using specific tools such as the Upper Limb Lymphedema questionnaire (ULL-27), the Lymphedema Life Impact Scale version 2 (LLISv2), and the LYMQOL-Leg questionnaire. These assessments help capture the impact of lymphedema and treatment on daily living. Throughout the study, participants complete these quality of life assessments for up to 40 months. The researchers monitor and compare the changes in quality of life between the surgical and non-surgical groups. This long-term follow-up allows for understanding the sustained effects of each management approach on patients' well-being and daily function.

Researchers are evaluating the combination of 2141-V11, an antibody that activates the immune system to target and kill prostate cancer cells, with standard treatments for prostate cancer. The study focuses on men with intermediate-risk, high-risk localized, and low volume metastatic prostate cancer. It aims to determine whether this treatment can completely eliminate cancer or reduce it to minimal residual disease, which means a very small number of cancer cells that remain after treatment. The study involves injecting the 2141-V11 antibody directly into the tumor before surgery for those with intermediate-risk disease. For men with high-risk localized or low volume metastatic disease, this antibody is combined with androgen deprivation therapy (hormone therapy). The treatment is given before radical prostatectomy, a surgery to remove the prostate gland, and lymph node dissection is performed as appropriate. Participants must undergo prostate magnetic resonance imaging to confirm the presence of prostate lesions. Participants will be monitored regularly for up to 24 months to assess their response to treatment, including whether they achieve complete response or minimal residual disease. The study includes blood tests to check organ function, clinical assessments of cancer stage, and safety monitoring for side effects or complications. Researchers will also track hormone levels and require participants to use effective birth control during and after treatment. The study is focused on men aged 18 years and older with prostate cancer and includes several exclusion criteria to ensure safety and accurate results.

This research aims to determine if it is practical to conduct a larger study evaluating the Breast Reconstruction Decision Aid Tool (RECONJOINT) for individuals considering breast reconstruction surgery after mastectomy, particularly those affected by breast cancer or a genetic predisposition to it. The study focuses on people 18 years and older who are exploring reconstruction options following breast removal due to cancer or related conditions. Participants will be introduced to the RECONJOINT decision aid, a tool designed to support decision-making for breast reconstruction surgery. The study includes focus groups, patient randomized controlled trial (RCT) participants scheduled for plastic surgery consultation, and physicians who provide significant breast reconstruction care. Different participant groups have specific criteria for involvement, and the intervention is studied in the context of these consultations. During the study, researchers will monitor participant enrollment to assess whether the study process is feasible within 60 days after the initial reconstructive surgery consultation and before the participant’s breast reconstruction surgery. They will evaluate how well participants engage with the decision tool, with an emphasis on recruitment and timing. The total duration and further procedures are not detailed but focus on the feasibility of using the RECONJOINT tool in clinical settings.

Researchers are evaluating different doses of abemaciclib combined with hormone therapy and radiation therapy in people with metastatic hormone receptor-positive, HER2-negative breast cancer. This Phase I study aims to find the maximum tolerated dose of abemaciclib when given concurrently with radiation therapy for bone metastases in patients with advanced breast cancer stage IV. Participants will receive abemaciclib in a dose escalation study using a 3+3 design to determine the best dose. Once the maximum tolerated dose is found, up to 10 more patients will join an expansion phase. Radiation therapy will be delivered as stereotactic body radiotherapy (SBRT) with doses of either 27 Gy over 3 daily treatments or 30 Gy over 5 daily treatments, all completed within 28 days. During the study, participants will be monitored up to one year to measure the maximum tolerated dose of abemaciclib. Assessments will include clinical evaluations, laboratory tests to confirm organ function, and safety monitoring. Patients must be able to swallow oral medications and will be followed closely for adverse effects while continuing hormone therapy as appropriate. Outcome measures focus on dose tolerance and treatment safety.

Researchers are evaluating a tailored anxiety treatment program called Managing Anxiety from Cancer (MAC) for Latino older adults with cancer and their caregivers. The study aims to understand if this program is practical and effective for this group, focusing on those aged 65 or older who are undergoing or have recently completed cancer treatment. Caregivers aged 40 or older who provide emotional or practical support to the patients may also participate. The MAC intervention consists of seven psychotherapy sessions lasting 45 to 60 minutes each, delivered via videoconference or telephone. These sessions are conducted by licensed social workers or advanced mental health trainees. The program is designed to be accessible in English or Spanish, with language fluency verified before enrollment. Both patients and caregivers who meet the criteria can take part in the study. Participants will complete study procedures over one year, during which researchers will monitor their progress and adherence to the program. The main outcome measured is the percentage of participants who complete all study procedures within this year. Participants will be assessed for anxiety levels and ability to engage in the intervention, with safety monitored throughout the study period.

Researchers are evaluating whether using Stimulan Rapid Cure to deliver antibiotics locally during surgery can reduce infection risks for women receiving tissue expanders after mastectomy. The study focuses on women undergoing mastectomy for breast cancer or high risk due to genetics or family history. It also investigates whether this treatment affects the risk of seroma, a fluid buildup complication after surgery. Participants will receive tissue expander placement during mastectomy with the antibiotics vancomycin and gentamicin delivered through Stimulan Rapid Cure during the surgical procedure. This approach is compared in a randomized controlled setting to assess its effectiveness in preventing infections related to breast tissue expanders. Throughout the study, researchers will monitor participants for surgical site infections within 90 days after surgery. They will also observe for seroma development and other complications. The total participation involves preoperative planning, surgery with the study intervention, and postoperative follow-up to evaluate safety and outcomes.

Researchers are evaluating the combination of avutometinib and defactinib as a potential treatment for patients with RAF dimer-driven radioiodine-refractory differentiated thyroid cancer or anaplastic thyroid cancer. This Phase II study aims to assess both the effectiveness and safety of these drugs, focusing on how well they work in treating these specific types of thyroid cancer and monitoring for any side effects. Participants will receive avutometinib at a dose of 3.2 mg twice weekly and defactinib at 200 mg twice daily, both given on a schedule of three weeks on treatment followed by one week off. The study includes two groups: Cohort A with differentiated thyroid cancer and Cohort B with anaplastic thyroid cancer, both driven by RAF dimer genetic alterations. Treatments are taken orally, and the study evaluates the overall response rate over a period of up to two years. During the study, participants will undergo various assessments including imaging scans to monitor tumor response, laboratory tests, and safety evaluations. Researchers will track how well tumors respond to treatment and any adverse effects. Participants are expected to be involved for up to two years, with ongoing monitoring to measure outcomes such as tumor shrinkage and overall treatment response.

Researchers are evaluating whether the combination of azacitidine and venetoclax can effectively reduce or eliminate measurable residual disease (MRD) in adults with acute myeloid leukemia (AML) who have completed standard chemotherapy and plan to undergo an allogeneic hematopoietic stem cell transplant (HSCT). This Phase 2 study focuses on patients with confirmed AML in remission but still showing evidence of MRD, aiming to lower the risk of disease relapse after transplant. Participants receive azacitidine at 75 mg/m2 daily for seven days, administered either intravenously or subcutaneously, along with venetoclax 400 mg taken orally every day for 28 days. The treatment is given before the planned stem cell transplant. The study does not include additional treatment phases or extension periods beyond this intervention. During the study, participants will be closely monitored for changes in MRD levels at one year to assess the treatment's impact. Evaluations include bone marrow biopsies and flow cytometry or molecular testing to measure residual disease. Safety assessments and organ function tests are conducted to ensure participants can tolerate the therapy. The study duration includes treatment and follow-up to track outcomes related to MRD conversion and transplant readiness.