Clyde

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

Researchers are evaluating the impact of the Cost Communication and Financial Navigation (CostCOM) program on how well cancer patients stick to their treatment plans and manage financial stress. Many people with cancer face financial difficulties due to high out-of-pocket costs and changes in employment or insurance, which can cause delays or interruptions in care and lower quality of life. This study compares CostCOM with enhanced usual care to see if it helps reduce financial hardship and improve care adherence and patient satisfaction. Participants are randomly assigned to one of two groups. One group receives a brochure about financial navigation services from the Patient Advocate Foundation. The other group receives standard financial care plus CostCOM financial counseling sessions lasting about an hour, given within 30 days of enrollment and again at 3, 6, and 12 months. Non-patient participants, such as providers or coordinators, may take part in surveys and interviews to share their experiences with the CostCOM program. Patients will be followed for 12 months after completing the intervention. During this time, they will complete surveys about their adherence to cancer care, financial hardship, worry, quality of life, and satisfaction with care at several points. Researchers will also assess the accuracy of cost estimates given to patients and explore neighborhood characteristics. The study includes interviews and surveys with non-patient participants conducted 15 to 39 months after the first patient enrollment.

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 evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase II/III 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 phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer (TNBC). This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.

Researchers are evaluating the addition of tivozanib to the immunotherapy drug pembrolizumab compared to pembrolizumab alone for patients with high-risk renal cell carcinoma (RCC). This phase III trial aims to assess whether combining these treatments improves disease-free survival and overall survival in patients who have undergone surgery to remove all known kidney cancer sites. The study also looks at side effects, quality of life, fatigue, and collects specimens for future research. Participants are randomly assigned to one of two groups. One group receives pembrolizumab intravenously on specific days within a 12-week cycle, repeated up to four cycles if no disease progression or unacceptable side effects occur. The other group receives the same pembrolizumab schedule plus oral tivozanib taken daily on specified days within the cycle for up to six months. Both groups have blood samples taken and undergo MRI or CT scans during the trial. Tissue biopsies may also be performed. After the treatment phase, participants are followed with check-ups every four months for two years, then every six months for three years, and then yearly for five more years. Researchers monitor disease recurrence, survival, side effects, treatment tolerance, and patient-reported quality of life and fatigue through questionnaires. This long-term follow-up helps evaluate the lasting effects and safety of the treatments.