Minot

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

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 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.

Researchers are establishing the Integrated Cancer Repository for Cancer Research iCaRe2 as a multi-institutional resource to collect and manage standardized, multi-dimensional, and longitudinal data and biospecimens from adult cancer patients, individuals at high risk, and normal controls. This resource covers a wide geographical area including small and rural hospitals and cancer centers. The goal is to advance comprehensive studies on cancer risk factors and enable development of new strategies for cancer prevention, screening, early detection, and personalized treatment. The iCaRe2 resource collects data and biospecimens such as tumor samples, germline DNA, serum, urine, and plasma from participants across multiple cancer registries covering various cancer types. It operates as a web-based, HIPAA-compliant platform allowing centers with different expertise to contribute and collaborate. This repository supports cohort and population studies by providing a secure, standardized, and interoperable system for cancer-related data collection and sharing. Participants include adult patients with cancer, individuals at risk, and normal controls who can provide informed consent. Data collected includes clinical information, biospecimens, and longitudinal follow-up. The study measures include the development and implementation of the web-based registry and banking of biological materials for future research. Participation involves consent and data contribution, with monitoring and data validation ensuring quality. The repository enables ongoing research collaborations to study cancer biology, genetics, epidemiology, and patient care.

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.

Radon is the second-leading cause of lung cancer after smoking and may also contribute to other cancer deaths. Children are particularly vulnerable due to their larger lung surface area and higher breathing rates. This research evaluates the feasibility of using a smartphone radon app to encourage radon testing among mothers of children aged 4 years or younger. The study aims to improve radon knowledge, self-confidence in testing, and promote radon test kit use and sharing of radon information. Participants will receive a free short-term radon test kit and access to a radon app designed to provide targeted education, step-by-step testing guidance, reminders, and prompts for sharing information socially. They are encouraged to download and use the app over a four-month period, engaging with mobile-friendly educational content based on EPA brochures. The study includes a baseline survey before app exposure, a follow-up survey at two months, and tracking of kit completion and return at four months. During the study, participants complete brief surveys at baseline and two months, while app usage is monitored through analytics like time spent and modules completed. The return of test kits is confirmed by laboratory analysis. Researchers measure recruitment and retention rates, app engagement, cognitive outcomes like knowledge and beliefs about radon testing, and behavioral outcomes such as test completion and sharing of radon information. Participation lasts about four months from enrollment to the end of kit tracking.