Egg Harbor Township

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating two digital mindfulness meditation programs to support mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III trial focuses on women diagnosed with breast cancer at age 50 or younger who have completed their main cancer treatments at least six months ago. The study aims to compare a live, instructor-led online program to a self-paced app-based program and also to explore factors that might influence how well these interventions work, including psychological distress levels and social factors like race and education. Participants will be assigned to one of three groups: a live online Mindful Awareness Practices (MAPs) program delivered over Zoom, a self-paced MAPs digital app, or a meditation-only control group. The live online program includes guided meditations, exercises to manage pain and emotions, and cultivating kindness, with daily home practice increasing from 5 to 20 minutes. The app program unlocks lessons sequentially as participants progress. Meditation use will be tracked across all groups to measure engagement. During the study, participants will report depressive symptoms two weeks after completing the intervention. Researchers will also collect information on emotion regulation strategies and social determinants of health, and monitor how much participants practice mindfulness to understand the programs' effects. The total intervention lasts six weeks, and participants must be able to use a digital device and communicate in English or Spanish. Safety and participation are closely monitored throughout the study.

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 collecting data in the RSSearch4 Registry to better understand how Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) are used to treat life-threatening tumors and other conditions. This international, multi-year registry tracks patient characteristics, treatment practices, and outcomes to help identify the most effective uses of these therapies over time. The study includes patients with various diagnoses such as neoplasms, arteriovenous malformations of the central nervous system, and trigeminal neuralgia. Participants receive SRS or SBRT treatments tailored to their specific conditions, with details of each treatment plan and outcomes recorded in the registry. The registry supports the inclusion of both prospective and some retrospective patient data to capture short- and long-term outcomes. The data collection enables participants to analyze treatment effectiveness, share findings, and collaborate with other centers. During the study, patient data on treatment and outcomes are collected and monitored, including specific measures relevant to each condition. The registry is managed by an independent vendor ensuring privacy and security compliance. Overall survival is tracked for up to five years to evaluate treatment impact. Patients agree to participate by signing an informed consent document or verbally consenting, and no specific exclusion criteria apply beyond unwillingness to participate.

Researchers are evaluating how well serum tumor marker directed disease monitoring (STMDDM) works for patients with hormone receptor positive, HER2 negative metastatic breast cancer. The study compares STMDDM with the usual care approach to see if overall survival is not worse using STMDDM. The trial also looks at healthcare costs, patient anxiety, quality of life, and preferences related to disease monitoring. Patients are randomly assigned to one of two groups. One group receives usual care with imaging at least every 12 weeks and other monitoring at the doctor's discretion for up to 312 weeks if the disease does not progress. The other group has their serum tumor markers checked every 4 to 8 weeks, with imaging only if markers are elevated, also for up to 312 weeks without progression. Additional assessments include quality-of-life and anxiety questionnaires. Throughout the study, participants undergo regular evaluations including imaging, blood tests for tumor markers, and patient-reported outcome questionnaires. Researchers track overall survival up to 312 weeks after randomization, along with healthcare costs and patient experiences. Participants must provide informed consent and are monitored for safety during the study period.

Researchers are comparing two treatment approaches for patients with brain metastases: stereotactic radiosurgery (SRS) and hippocampal-avoidant whole brain radiotherapy (HA-WBRT) combined with the drug memantine. SRS is an outpatient procedure delivering a high dose of radiation to small brain areas in one or two days, while HA-WBRT aims to treat the whole brain but reduce radiation to the hippocampus, which is important for memory. Memantine is used alongside HA-WBRT to help relieve symptoms like memory problems caused by radiation. This phase III trial seeks to determine if SRS is better, the same, or worse than the usual treatment with whole brain radiation therapy (WBRT) alone, considering cancer control, life span, quality of life, and symptoms. The study compares two groups: one receiving SRS with a single dose of 18-22 Gy, and the other receiving HA-WBRT radiation at 30 Gy over 10 sessions plus memantine starting at 5 mg and increasing weekly up to 20 mg daily. Patients must have between 5 and 15 brain metastases, with no single tumor larger than 2.5 cm. The trial requires participating centers to have specific radiosurgery equipment and credentialing. Treatment must begin within 14 days after enrollment. Both approaches are closely monitored to assess their effects. Participants will undergo MRIs and neurocognitive testing to evaluate memory and brain function over 4.5 years. Researchers will track overall survival and neurocognitive progression-free survival as primary outcomes. Patients will complete quality-of-life questionnaires in English or French, and their kidney function will be tested before treatment. The study includes careful documentation of treatment effects, side effects, and follow-up visits to ensure thorough evaluation of both treatment options.