Lakewood

Researchers are observing how avacincaptad pegol is used in routine clinical practice for people with geographic atrophy caused by age-related macular degeneration AMD. Geographic atrophy is an advanced form of AMD where retinal cells waste away, leading to worsening central vision and potential permanent vision loss. This observational study collects information on treatment and medical events related to avacincaptad pegol without influencing the doctors treatment decisions. Participants in this study have chosen to begin treatment with avacincaptad pegol, delivered as intravitreal injections into the eye. The study records how often and how long the treatment is given, along with reasons for stopping treatment. It monitors participants receiving this treatment in one or both eyes as part of their regular medical care, without additional interventions from the study. During the study, participants will have eye exams as part of their usual care and will complete surveys about their eye health at the start of treatment, every six months for two years, and then yearly. Researchers will gather data from medical records to track treatment usage, vision changes, and any adverse events for up to about five years. This long-term observation helps understand real-world treatment patterns and safety.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

Researchers are evaluating a new schedule of alternating cycles of chemoimmunotherapy chemotherapy plus pembrolizumab and immunotherapy pembrolizumab alone as the first treatment for patients with advanced lung or head and neck cancers. This phase II study aims to see if less frequent chemotherapy during the induction phase can effectively control the cancer while preserving quality of life. The trial also monitors safety and response rates over time. The study has three groups based on cancer type. Each group receives alternating cycles combination chemoimmunotherapy cycles consisting of drugs like carboplatin, paclitaxel, pemetrexed, or 5-fluorouracil with pembrolizumab, followed by cycles of pembrolizumab alone. The number of cycles varies by group, with up to four or six cycles during induction. After induction, maintenance therapy with pembrolizumab alone or combined with pemetrexed continues for up to two years. Participants will have regular assessments including imaging and laboratory tests before and during treatment to measure tumor response and monitor side effects. Researchers will track how many patients complete the induction therapy cycles and evaluate overall response rates at 6 weeks. Safety is monitored throughout the study, which can last up to three years for progression and adverse event follow-up. Patients will provide informed consent and be closely monitored during the trial.

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 studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are evaluating a dietary fiber formula called NBT-NM108 in patients with metastatic colon cancer receiving irinotecan-based chemotherapy. Irinotecan often causes diarrhea, which can be severe and affect treatment tolerance. This phase II trial aims to see if NBT-NM108 can reduce diarrhea symptoms by promoting a healthier gut microbiome, potentially improving patients ability to continue their chemotherapy. Participants are randomly assigned to one of two groups one group receives NBT-NM108 drinks four times daily before meals and two hours after dinner for 56 days, starting five days before chemotherapy begins. Both groups receive irinotecan-based chemotherapy as standard care. The study compares the dose intensity of irinotecan administered, diarrhea severity, treatment response, and progression-free survival between the groups. Additional analysis includes gut microbiota sequencing and tests for gut inflammation and barrier function. During the study, participants undergo assessments of treatment-related side effects and tumor response by imaging. Researchers monitor diarrhea toxicity, need for chemotherapy dose modifications, and microbiome changes. The main outcome is measured at eight weeks, with imaging done before chemotherapy and at six weeks after treatment starts. Participants are followed throughout the treatment period to evaluate safety, treatment tolerance, and microbiome effects.

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 trial studies adults with advanced non-small cell lung cancer NSCLC that has spread outside the lungs and has specific mutations in the EGFR gene. Researchers are comparing two treatment approaches osimertinib alone versus osimertinib combined with bevacizumab. The study aims to evaluate how these treatments affect the time patients live without disease progression and overall survival, as well as their effects on brain metastases and treatment safety. Participants are randomly assigned to one of two groups. One group receives osimertinib pills daily every 21 days, while the other group receives osimertinib daily plus an intravenous infusion of bevacizumab every 21 days. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants undergo tests including echocardiography, MUGA scans, CT scans, and possibly MRI, along with blood and urine sample collection. After treatment ends, participants are followed every three months for up to 10 years to monitor disease status and survival. Researchers will assess progression-free survival, overall survival, response rates, time to brain progression, and side effects. The study includes long-term follow-up to understand the lasting effects of these treatments and to explore resistance mechanisms through tumor DNA analysis.

This research aims to evaluate dose escalation in radiation therapy for patients with painful non-spinal bone metastases and painful non-bone metastases. The goal is to increase the complete pain response rate at one month by delivering higher doses of radiation in a carefully controlled manner. Researchers also seek to assess whether this intensified treatment leads to more durable pain relief, better quality of life, and acceptable safety in patients with cancer spread to bones or other areas. Participants will receive external beam radiation therapy with a prescribed dose of 50 Gy given in 10 fractions, though this may be reduced to 40 Gy in 8 fractions for some non-spinal metastases to protect normal tissues. Radiation treatments are delivered daily with a minimum of three sessions per week, and any missed treatments will be made up to complete the planned course. If participants experience unacceptable side effects but still benefit from the treatment, they may be allowed to continue under investigator discretion. During the study, participants will be monitored for safety by tracking adverse events and treatment-related toxicity within one month post-treatment. Researchers will also evaluate pain severity, duration of pain relief, quality of life changes, and the need for retreatment due to disease progression. The total participation time varies with follow-up assessments focusing on treatment impact and safety outcomes. The study is sponsored by Rutgers, The State University of New Jersey, and is designed as a phase 2 interventional trial.