Greenwood

Researchers are studying the effects of the drug velmanase alfa Lamzede in children under 3 years old who have Alpha-Mannosidosis, a rare genetic condition. The study aims to understand how velmanase alfa affects a specific disease marker called GlcNAcMan2 after one year of treatment and to observe how the childs body responds to the drug during therapy. This research collects data from real-world treatment experiences, including routine clinical tests and other observational studies. Participants are pediatric patients diagnosed with alpha-mannosidosis who have started treatment with velmanase alfa before turning three years old. They receive Lamzede as an intravenous enzyme replacement therapy at a dose of 1 mgkg once weekly. The study uses existing clinical data collected before and after treatment, focusing on samples taken prior to treatment initiation and after at least six weeks of therapy. During the study, parents or legal guardians provide test results from routine healthcare visits related to their childs general health and the administration of velmanase alfa. Researchers analyze these data to measure pharmacodynamic response over 52 weeks of treatment, focusing on changes in the disease marker GlcNAcMan2. The study continues until September 2029 and does not involve additional interventions beyond standard care and data collection.

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

Researchers are comparing two treatment approaches for patients with stage II-IIIB non-small cell lung cancer NSCLC that can be removed by surgery. The study evaluates whether giving standard therapy before and after surgery perioperative is better than giving it only after surgery adjuvant. This phase III trial focuses on chemotherapy and immunotherapy, which are current standard treatments aimed at controlling tumor growth and helping the immune system fight cancer. Patients are divided into two groups. One group undergoes surgery followed by chemotherapy and immunotherapy for up to one year if the disease does not progress or cause severe side effects. The other group receives chemotherapy combined with immunotherapy before surgery, then surgery, followed by immunotherapy alone for up to one year. Chemotherapy drugs may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, or vinorelbine. Imaging tests like CT, MRI, or PETCT scans are done throughout the study. Participants will have surgery within a month of joining and receive treatments according to their assigned group. They will be monitored with scans and followed up every six months for up to 10 years to assess survival, disease progression, surgical outcomes, side effects, and immune responses. Researchers will measure event-free survival and overall survival as main results, as well as response rates and safety information over the long term.

Researchers are evaluating an online educational program called Current Together After Cancer CTAC to see if it helps colorectal cancer survivors who had surgery receive follow-up care that matches current guidelines. This phase III trial focuses on patients with stage II or III colorectal cancer who have had their tumors surgically removed. The study aims to improve patients knowledge about surveillance, their confidence in managing follow-up care, and satisfaction with the involvement of a supporter in their care. Patients in the trial are randomly assigned to one of two groups. One group and their supporter get access to the CTAC intervention website, which contains educational content and interactive modules related to colorectal cancer surveillance. The other group and their supporter receive access to a general health education website. Participants may review their assigned website as often as they like for up to 16 months. During the study, participants will complete questionnaires at baseline, 3 months, and 16 months to assess knowledge, self-efficacy, cancer worry, preferences, and satisfaction with supporter engagement. Researchers will measure whether patients receive colorectal cancer surveillance aligned with guidelines at 16 months. The study also explores how supporters participation relates to patient outcomes. Participants may be contacted via email or phone for study activities and are encouraged to complete all scheduled assessments.

Researchers are evaluating the effects of lenalidomide and dexamethasone with or without daratumumab in treating patients with high-risk smoldering multiple myeloma. This phase III trial aims to compare overall survival, progression-free survival, response rates, and safety between these treatments. The study also explores patient-reported quality of life, treatment adherence, minimal residual disease status, and imaging associations during therapy. Participants are randomly assigned to one of two treatment groups. The first group receives daratumumab intravenously on a detailed schedule across up to 24 courses, plus oral lenalidomide daily for 21 days and dexamethasone on specific days during the first 12 courses. The second group receives only oral lenalidomide and dexamethasone on a similar schedule for up to 24 courses. Treatment cycles repeat every 28 days unless disease progression or unacceptable side effects occur. During the study, participants complete quality-of-life questionnaires and undergo laboratory tests, including minimal residual disease assessments and PETCT imaging. Safety is closely monitored, especially infusion-related reactions and toxicity. After treatment, patients are followed for up to 15 years with periodic visits every 3 to 12 months to track long-term outcomes and survival.

Researchers are studying the relationship between low muscle mass myopenia at diagnosis and chemotherapy side effects in older adults newly diagnosed with advanced colorectal cancer. This prospective cohort study also investigates how genetic differences may influence the link between myopenia and chemotherapy toxicity, focusing on overall survival in this population receiving specific chemotherapy treatments. Participants in this observational study are older adults with metastatic colorectal cancer who are starting or recently started 5-Fluouracil 5-FU based chemotherapy, alone or combined with other drugs like oxaliplatin, irinotecan, or immunotherapy. The study groups include adults aged 60-74 years and those 75 years or older. The study tracks chemotherapy toxicities over 6 months following treatment initiation. During the study, participants will be monitored for chemotherapy toxicities graded 3 to 5 and overall survival for up to one year. Researchers will collect information through questionnaires available in English or Spanish and assess the impact of muscle mass and genetics on treatment side effects and survival. The total participation time varies, with ongoing assessments during and after chemotherapy treatment.

Researchers are evaluating whether simply observing patients after surgery is as effective as continuing pembrolizumab treatment in preventing cancer recurrence in people with early-stage triple-negative breast cancer TNBC who had a complete response after receiving chemotherapy plus pembrolizumab before surgery. This Phase III trial aims to determine if stopping pembrolizumab post-surgery can maintain recurrence-free survival while potentially improving quality of life and reducing treatment burden. Participants are randomly assigned to one of two groups after finishing chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab intravenously every 3 or 6 weeks for 27 weeks. The other group undergoes observation without further pembrolizumab for the same period. Throughout the study, patients have tumor biopsies and blood collected, along with imaging such as mammography, breast ultrasound, or MRI during follow-up. Participants will be monitored for recurrence-free survival and overall survival for up to 10 years. The study also assesses adverse events, quality of life, financial impact, and work productivity at about 27 weeks after starting the assigned treatment or observation. Safety and treatment effects are tracked through biopsies, imaging, blood tests, and patient questionnaires during the study and follow-up.

This observational study follows individuals diagnosed with Rett syndrome who have mutations in the MECP2 gene. It gathers detailed information on the signs and symptoms of Rett syndrome as reported by expert clinicians and caregivers. The purpose is to use this data to develop consensus-based care guidelines and support the advancement of clinical trials and drug development for Rett syndrome. Participants are observed over a period of up to five years without receiving any experimental treatments. Data collection focuses on the natural history of the condition, capturing changes and progression as reported by medical experts and caregivers. There is no intervention or drug administration involved in this study. During the study, participants and their caregivers provide information on symptoms and health status. Researchers compile this data to understand the course of Rett syndrome better. The main outcome measured is the natural history over five years. Participants contribute information through routine clinical observations and caregiver reports throughout the study duration.

Researchers are evaluating patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based therapy and are at risk of heart problems. The study includes two groups one large observational group taking beta blockers, ACE inhibitors, or ARBs alongside trastuzumab, and a smaller randomized group comparing the effects of carvedilol versus no treatment. The aim is to understand the occurrence of heart issues and whether carvedilol might help prevent cardiac side effects from chemotherapy. Participants are assigned to one of three arms based on their current medications. Patients not on beta blockers, ARBs, or ACE inhibitors are randomized to either receive carvedilol orally twice daily or no study intervention. Those already taking these heart medications enter an observational arm without additional treatment. Treatment and observation continue for up to 108 weeks unless disease progression or unacceptable side effects occur. Throughout the study, participants undergo heart function monitoring with echocardiograms every 12 weeks and provide blood samples for biomarker analysis. Researchers track the time to the first sign of heart dysfunction and any cardiac events, as well as adherence to medication and side effects. The study also collects data to develop models predicting heart risk and banks samples for future research. Participant involvement may last over two years with regular assessments to monitor safety and heart health.

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.