Egg Harbor Township

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating two digital mindfulness-based interventions to improve mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III randomized trial focuses on women diagnosed at or before age 50, who completed primary cancer treatments at least six months earlier. The study aims to compare the effectiveness of live instructor-led sessions via Zoom and a self-paced app-based program, exploring which approach best supports psychological health in this population. Participants will be assigned to one of three groups the live online mindfulness sessions MAPs LO conducted weekly for 6 weeks via Zoom, the MAPs App delivering the same content in shorter sessions over 6 weeks, or a meditation-only control group accessing guided audio meditations. Both English and Spanish speakers can participate in the live online and meditation groups, while the app is only available in English. Tablets and internet hotspots are provided if needed. All groups have access to the UCLA MARC mindfulness meditation app throughout the 6-month follow-up. During the study, participants will attend weekly sessions for the live group or engage with app content at home, with usage tracked to measure intervention dose. Researchers will assess depressive symptoms shortly after the intervention and again up to 6 months later, along with fatigue symptoms. They will also investigate factors influencing intervention effects, such as baseline distress and social determinants, and evaluate the cost-effectiveness of the programs. The total study duration includes a 6-week intervention period plus follow-up assessments out to 6 months.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This research aims to collect and analyze long-term data on the use of Stereotactic Radiosurgery SRS and Stereotactic Body Radiation Therapy SBRT in treating patients with life-threatening tumors and other medical conditions. The study is an international, multi-year observational registry designed to understand how these treatments are used and their outcomes in everyday clinical practice. It continues the work of a prior study focused on CyberKnife treatment and is sponsored by The Radiosurgery Society. Participants in this study include patients with various conditions considered treatable by SRS or SBRT. The study captures information such as patient characteristics, disease details, treatment plans, and outcomes. This data collection allows participating sites to track treatment effectiveness and share their experiences. The registry is maintained by Vision Tree, Inc., which ensures data security and compliance with privacy regulations. Both prospective and some retrospective patient data are included. During the study, participants treatment outcomes are monitored over time, including overall survival for up to five years and local or distant recurrence within one to five years. The registry allows detailed recording of outcomes specific to each condition treated. Patients provide consent to participate, and their data contributes to improving understanding of these advanced radiation therapies. The total duration of participation varies as the study is ongoing and collects long-term results.

Researchers are evaluating how well serum tumor marker directed disease monitoring STMDDM works compared to usual care in patients with hormone receptor positive, HER2-negative metastatic breast cancer. This trial aims to see if monitoring with serum tumor markers can provide similar overall survival outcomes to the standard approach, which involves regular imaging scans. The study also looks at healthcare costs, patient anxiety, and quality of life related to these monitoring methods. Participants are randomly assigned to one of two groups. In the usual care group, patients receive imaging studies at least every 12 weeks and may have serum tumor marker tests as determined by their doctor. In the STMDDM group, patients have blood tests for specific tumor markers every 4 to 8 weeks, and imaging scans are only done if these markers indicate a possible progression of disease. Both groups continue their monitoring for up to 312 weeks unless the disease progresses. During the study, participants undergo regular assessments including blood tests for tumor markers, imaging scans as needed, and questionnaires about anxiety and quality of life. Researchers track overall survival for up to 312 weeks and compare healthcare costs and patient-reported outcomes for up to 48 to 102 weeks. The study also collects data on how often and by what methods disease monitoring is performed, along with patient and physician preferences related to monitoring.

Researchers are comparing two treatments for patients with 5 or more brain metastases stereotactic radiosurgery SRS and hippocampal-avoidant whole brain radiotherapy HA-WBRT combined with the drug memantine. This study aims to find out if SRS is better, the same, or worse than the usual treatment approach, which is whole brain radiation therapy alone. The study will assess how these treatments affect cancer control, overall survival, memory, quality of life, and cancer-related symptoms. Participants will be randomly assigned to receive either SRS, which delivers a high dose of radiation to specific small areas in the brain in a single session, or HA-WBRT plus memantine. HA-WBRT involves radiation to the whole brain while avoiding the hippocampus area to protect memory, given in 10 radiation fractions totaling 30Gy. Memantine is given starting at 5 mg and increased weekly to a target dose of 20 mg daily in divided doses. Treatment is provided as an outpatient procedure. During the study, participants will undergo regular assessments including MRI scans, neurocognitive testing, quality of life questionnaires, and blood tests to measure biomarkers. Researchers will monitor survival, brain cancer control, cognitive function, side effects, and treatment costs over 4.5 years. The study also includes collecting imaging and blood samples to understand treatment effects and brain changes. Participants are expected to be available for treatment, follow-up, and completing questionnaires throughout the study period.

Researchers are evaluating whether adjusting the timing of doses for the prostate cancer drug Lutetium 177 Lu PSMA RLT can improve quality of life without reducing lifespan in patients with hormone-resistant prostate cancer that may have spread nearby or to distant sites. This phase III trial compares the standard dosing schedule with an adaptive dosing approach based on disease activity. The study focuses on patients whose cancer cells express a protein called PSMA, which the drug targets. Participants first receive two doses of Lutetium 177 Lu PSMA RLT intravenously every 6 weeks. Those showing sufficient PSA decline then enter a randomized phase where one group continues standard dosing every 6 weeks for up to four more doses, while the other group has treatment delayed and resumed adaptively based on PSA levels and clinical signs. Throughout the trial, patients undergo blood tests, CT scans, bone scans, PSMA PET scans during screening, and MRI if indicated. Treatment continues unless disease progresses or unacceptable side effects occur. During the study, participants have regular PSA monitoring, blood samples collected, and imaging tests to assess disease status and side effects. Quality of life, overall survival, pain severity, and treatment toxicity are measured up to several years. After treatment, patients are followed every 12 weeks until disease progression and then every 6 months for up to 5 years. The study aims to understand if adaptive dosing can maintain survival while improving life quality for men with advanced prostate cancer.