NewYork-Presbyterian / Columbia University Irving Medical Center

Researchers are creating a multi-center, non-interventional registry called Registry of Asthma Characterization and Recruitment 3 RACR3 to build and maintain a database of participants. This registry supports recruitment for current and future studies sponsored by the DAIT NIAID Childhood Asthma in Urban Settings CAUSE program. The registry aims to include about 1,500 participants of all ages living in specific metropolitan areas defined by the Office of Management and Budget OMB. Both individuals with asthma or allergies and healthy controls without these conditions may join to help validate tests and train study personnel. Participants provide data primarily during a single main visit, with optional additional visits possible. The registry collects information on various asthma and allergy characteristics, following national guidelines to ensure participant safety. Healthy controls may be included for validation or training purposes. Participants may withdraw their information or leave the registry at any time by contacting the study team in person, by phone, or in writing. During the study, participants will undergo assessments related to asthma and allergy traits. Researchers will monitor the number of participants with these characteristics over a seven-year period. The registry also ensures safety follow-up through regular contact methods. Overall participation length varies, and the registry serves as a resource to identify candidates for future asthma-related research studies sponsored by NIAID.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

This research aims to gather health information from infants, children, adolescents, and young adults diagnosed with cancer to improve treatment and ongoing care. It maintains a Childhood Cancer Registry and uses clinical and biological data to identify eligibility for Childrens Oncology Group therapeutic trials. The study also develops a biorepository of biospecimens and clinical data for current and future research, including tumor and host DNA samples, and allows for future contact regarding additional research studies. Participants are assigned to one of two observational protocols. In the Project Every Child Protocol, medical data is reviewed to create a cancer registry, and biospecimens such as tissue, blood, bone marrow, plasma, serum, saliva, cerebrospinal fluid, or urine are collected. In the Project AYA Protocol, biospecimens are collected similarly. These samples are gathered at diagnosis, progression, recurrence, or post-mortem where applicable. During the study, participants undergo medical chart reviews and biospecimen collections. Researchers measure the number of patients consenting to biobanking as a primary outcome. Clinical data including diagnosis, staging, treatment summaries, and outcomes are recorded. The study involves ongoing data collection over time to support future research and screening for trial eligibility, with participation lasting as long as data and samples continue to be collected.

This research evaluates the real-world safety and long-term effectiveness of catheter ablation procedures in treating patients with paroxysmal atrial fibrillation PAF, persistent atrial fibrillation PsAF, and ventricular arrhythmias VA. The study is an observational, prospective, multi-center registry collecting clinical data from the use of commercially available CARTO technologies by Biosense Webster, Inc. These procedures are performed under usual care by healthcare practitioners. Participants receive catheter ablation using Biosense Websters CARTO devices such as THERMOCOOL SMARTTOUCH, QDOT MICRO, and VARIPULSE catheters. The registry includes patients with symptomatic PAF or PsAF who are candidates for ablation, as well as patients with documented ventricular arrhythmias suitable for catheter ablation. The ablations follow standard care practices at participating sites, and future new ablation technologies may also be included as they become available. Throughout the study, participants undergo routine baseline and follow-up evaluations aligned with standard care without extra visits required by the registry. Researchers monitor outcomes including procedural efficiency, acute safety within 30 days post-ablation, arrhythmia recurrence after a 90-day blanking period, and long-term effectiveness up to 12 months. Patient-reported symptoms, medication usage, and clinical scores such as CHA2DS2VASC are also collected to assess the overall impact of the ablation procedures.

Researchers are evaluating the anti-tumor activity and safety of amivantamab, both alone and combined with standard chemotherapy, in people with advanced or metastatic colorectal cancer. This includes assessing the recommended dose when amivantamab is added to chemotherapy. Colorectal cancer is a common cancer worldwide, and this study addresses the role of specific receptors involved in tumor growth and resistance to existing treatments. Participants will receive amivantamab either as a monotherapy or in combination with standard chemotherapy regimens such as mFOLFOX6 or FOLFIRI. Amivantamab is given as an intravenous infusion, with doses adjusted based on body weight and specific cohort assignments. Treatment cycles last 28 days and continue until the study treatment ends or the participant discontinues. The study includes a screening period of up to 28 days before treatment starts. During the study, participants will undergo physical exams, performance status evaluations, laboratory tests, vital sign monitoring, and adverse event tracking to assess safety. Tumor assessments will be performed regularly to evaluate treatment response. The primary outcomes include objective response rates and the number and severity of dose-limiting toxicities and adverse events. The study may last up to several years, with follow-up visits up to 30 days after treatment ends.

Researchers are conducting a Phase 12, multicenter, randomized, open-label study to assess the safety and effectiveness of investigational agents used with or without pembrolizumab andor chemotherapy in participants with advanced esophageal squamous cell carcinoma ESCC who have previously received PD-1PD-L1 based treatment. This study aims to explore new treatment options for individuals whose cancer has progressed after initial immune therapy. Participants will be assigned to different treatment groups. Some will receive paclitaxel or irinotecan chemotherapy on specific schedules until disease progression or discontinuation. Others will receive combinations including pembrolizumab with MK-4830 plus paclitaxel, irinotecan, or lenvatinib. Additional groups will receive sacituzumab tirumotecan at varying doses on a 42-day cycle. Supportive medications may be given to manage side effects as needed. During the study, participants will undergo evaluations to monitor safety, including tracking dose-limiting toxicities and adverse events during an initial safety phase of about 3 weeks. Effectiveness will be assessed over up to 48 months by measuring tumor response and longer-term outcomes such as progression-free survival, duration of response, and overall survival up to approximately 70 months. Participants will have regular visits for treatment and monitoring throughout their involvement, which may last several years.

Researchers are evaluating the safety and effectiveness of BHV-3000 rimegepant compared to a placebo for treating moderate to severe migraine attacks in children and adolescents aged 6 to under 18 years. This Phase 3 clinical trial focuses on acute migraine treatment in a pediatric population, aiming to measure pain freedom two hours after dosing and other migraine-related symptoms to understand how well the treatment works in this age group. Participants receive either BHV-3000 rimegepant 75 mg or 50 mg orally disintegrating tablet ODT, or a matching placebo tablet. The study uses a randomized, double-blind design where participants are assigned to one of these groups. The trial monitors the effects of the medication shortly after administration and compares outcomes between the active drug and placebo groups. During the study, participants will be assessed for pain relief, freedom from the most bothersome migraine symptoms, and need for rescue medication within 24 to 48 hours after treatment. Researchers will also evaluate sustained pain freedom and the ability to function normally following the migraine attack. Various outcome measures include pain and symptom assessments at 2 hours post-dose, along with tracking medication use and migraine impact. The trial lasts until the primary completion date in January 2029, with ongoing safety and efficacy monitoring throughout.

Researchers are evaluating the combination of abemaciclib and olaparib in treating women with recurrent platinum-resistant ovarian cancer, a type of ovarian cancer that initially responds to platinum-based chemotherapy but returns within six months. This phase IIb trial aims to identify the side effects and best dose of abemaciclib when given together with olaparib. The study also explores the anti-tumor activity of this combination and collects genetic and biomarker data to understand treatment responses better. Participants receive olaparib orally twice daily for 28-day cycles, with abemaciclib added from day 8 to day 28 in the first cycle and throughout subsequent cycles, continuing until disease progression or unacceptable side effects occur. The study includes procedures like blood collection and tumor biopsies. After completing treatment, participants are followed up for 30 days to monitor outcomes and safety. During the study, participants undergo regular assessments including blood tests and tumor biopsies to measure response and side effects. Researchers track the maximum tolerated dose and recommended phase 2 dose after the first 28-day cycle. They also observe overall response rates and duration of response following treatment completion. Genetic and biomarker analyses are performed on collected samples, and safety is monitored throughout participation, which may last several treatment cycles plus follow-up.

Researchers are evaluating whether the drugs mosunetuzumab and polatuzumab vedotin can provide benefits for patients with diffuse large B-cell lymphoma or grade 3b follicular lymphoma that has returned or not responded to treatment. This study focuses on patients who have already received chemotherapy with fludarabine and cyclophosphamide, followed by CAR T-cell therapy. The goal is to determine if adding these drugs after previous treatments may better control or shrink the cancer. Participants first receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by one of three CAR T-cell therapies given by infusion tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel. After this, participants are randomly assigned to one of four groups receiving mosunetuzumab alone, polatuzumab vedotin alone, both drugs together, or observation without further drug treatment. Those in the observation group who experience disease progression within 12 months may switch to receive both drugs. Throughout the study, patients undergo PET-CT or CT scans and provide blood and tissue samples for research. Participants will be monitored regularly with imaging scans and laboratory tests to assess disease status and treatment effects. Researchers will measure progression-free survival, overall survival, remission rates, and treatment side effects up to two years. The study also includes collecting and banking tissue samples and PET-CT images for future research. The total length of involvement depends on individual timelines but includes treatment and follow-up periods extending up to two years or more.

Researchers are studying very low-risk and low-risk fusion negative rhabdomyosarcoma, a type of soft tissue cancer, to maintain excellent treatment outcomes while reducing therapy burdens. This phase III trial also evaluates how well patients with certain DNA mutations respond to different chemotherapy regimens and examines the use of centralized molecular risk stratification in treatment planning. The study aims to improve outcomes by adjusting therapy intensity based on molecular features. Patients are assigned to one of three treatment regimens based on their risk level and mutation status. Very low-risk patients receive vincristine and dactinomycin over 24 weeks in 8 cycles. Low-risk patients receive 12 weeks of vincristine, dactinomycin, and cyclophosphamide followed by 12 weeks of vincristine and dactinomycin, totaling 8 cycles. Patients with MYOD1 or TP53 mutations switch to an intensified 12-13 cycle regimen including vincristine, dactinomycin, and cyclophosphamide. Radiation therapy may be given at cycle 5 for some patients. Treatments are administered intravenously every 21 days. Throughout the study, participants undergo CT scans, MRI, bone scans, PET scans, and tumor biopsies to monitor disease status. Blood and tissue samples are collected at various times for research purposes. Researchers measure failure-free survival and overall survival over several years to assess treatment success. The trial lasts up to five years with ongoing assessments to track patient outcomes and safety.