Emeryville

Researchers are evaluating two treatment combinations for patients with melanoma that has spread to the brain and has a specific BRAF-V600 mutation. This phase II trial compares encorafenib, binimetinib, and nivolumab against ipilimumab and nivolumab to determine which approach better controls and shrinks brain metastases from melanoma. The study also aims to assess overall survival, response rates, treatment duration, and side effects of each regimen. Participants are randomly assigned to one of two groups. One group receives encorafenib orally once daily, binimetinib orally twice daily, and nivolumab intravenously every 28 days. The other group receives nivolumab intravenously and ipilimumab intravenously during the first four cycles, with cycles every 21 days initially, then every 28 days thereafter. Treatment continues unless the disease worsens or side effects become unacceptable. After treatment ends, participants have follow-up visits every six months for two years, then yearly until three years after starting the study. During the trial, participants undergo brain MRIs to monitor tumor response using standardized criteria. Imaging, tumor tissue, spinal fluid, stool, and blood samples are collected for research. Safety and effectiveness are carefully assessed through scans, physical exams, lab tests, and side effect monitoring. Progression-free survival up to three years after randomization is the main outcome. Participants remain in the study for about three years with periodic evaluations to track their health and disease status.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

This research collects data and biological samples from patients who have experienced side effects from immunotherapy treatments for cancer. The goal is to create a national collection of these samples and clinical information to help future studies understand, predict, prevent, and treat serious immune-related side effects, rare infections, or rapid tumor growth after immunotherapy. Participants provide tissue and blood samples when they join the study and again one month later. Some patients may also provide stool samples if they have certain side effects like colitis. Researchers also review participants' medical records for up to one year to gather detailed health information related to their treatment and side effects. During the study, patients undergo sample collections and have their health records examined. The main outcome measured is the establishment of a national biorepository containing these samples and data, which will be used in future research over the course of one year. This study aims to support better understanding and management of immunotherapy side effects in cancer treatment.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are studying how social and genetic factors affect outcomes for adolescent and young adult (AYA) survivors of Hodgkin and non-Hodgkin lymphoma. Compared to children and older adults, AYAs with these cancers face unique biological, clinical, psychological, and social challenges that influence their risk of illness and early death after treatment. By collecting blood samples and detailed health and treatment information, the study aims to better understand these risks and improve support for AYA cancer survivors. Participants in this observational study provide blood samples and complete health-related quality of life questionnaires at the start of the study and again at 6, 12, 18, and 24 months. The study examines how social-environmental risk factors and individual resilience relate to disease-free survival, overall survival, and quality of life. It also explores how gene expression changes may mediate these effects and whether factors like race, sex, gender identity, and geography influence outcomes. Throughout the two-year period, researchers monitor participants for disease-free survival, overall survival, and comorbidities including symptoms and late effects. The study collects repeated assessments through questionnaires and blood draws to track health status, quality of life, and biological markers. This comprehensive approach helps identify factors that impact long-term health for adolescent and young adult lymphoma survivors.

Researchers are evaluating the incidence of colorectal cancer in people aged 45 to 70 who have 1 to 2 non-advanced adenomas, which are small precancerous polyps without high-risk features. The study compares outcomes between those who have surveillance colonoscopies every 5 years versus every 10 years. This is important because current guidelines recommend follow-up colonoscopy but lack clear evidence on the best timing for patients with non-advanced adenomas. Participants will undergo colonoscopies at either 5 and 10 years or just at 10 years after their initial qualifying colonoscopy. All colonoscopies, including any unscheduled ones, will follow standard quality procedures and preparation instructions. The initial colonoscopy must have fully visualized the cecum and completely removed all polyps. Sessile serrated polyps without advanced features are also included as non-advanced adenomas. During the trial, researchers will monitor participants through colonoscopy exams and collect data on the incidence of colorectal cancer over a 10-year period. The main measurement is the rate of colorectal cancer occurrence. The study also includes assessments to ensure adherence to colonoscopy quality standards and will follow participants long term to observe safety and effectiveness of the surveillance intervals.

Researchers are evaluating the feasibility and acceptability of completing patient-reported outcomes (PROs) among adolescents and young adults (AYAs) aged 18 to 39 with various types of cancer. This pilot randomized controlled trial compares two approaches: allowing AYAs to choose five health-related quality of life (HRQOL) domains to report on (Choice PRO) versus assigning five fixed domains (Fixed PRO). The study aims to improve how PRO data is collected and used to better address patient needs in clinical and supportive care settings. Participants will be randomly assigned to either the Choice PRO group, where they select five of 15 PRO domains to complete at each assessment, or the Fixed PRO group, where they complete the same five predetermined domains at each time point. Assessments will be completed online using the EASEE-PRO platform at baseline and 1, 3, 6, and 12 months. Reminder calls and text messages will be used to encourage adherence and reduce missing data. The study will also explore how AYAs want their PRO data shared with themselves, their families, and healthcare providers. During the study, participants will complete questionnaires combining computerized adaptive tests and fixed short forms. Researchers will measure the completion rates and acceptability of the PROs at one month and baseline, respectively, and compare these between groups. The study requires participants to have internet access and the ability to provide informed consent and accurate self-reports. The total participation time includes follow-up over one year with multiple assessments to capture patient experiences and preferences.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma in this phase III trial. The study compares the effects of lenalidomide and dexamethasone given with or without daratumumab. These drugs work in different ways to stop tumor growth, and the combination with daratumumab, an immunotherapy, may better interfere with tumor cell growth and spread. The trial aims to assess overall survival, progression-free survival, treatment safety, and quality of life among participants. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on specific days across up to 24 cycles, combined with daily oral lenalidomide for 21 days and oral dexamethasone on days 1, 8, 15, and 22 for 12 cycles. The other group receives only lenalidomide and dexamethasone on the same schedule for up to 24 cycles. Treatment continues every 28 days until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans, and patient questionnaires to monitor treatment effects and quality of life. Researchers track overall survival for up to 15 years, evaluate minimal residual disease, and monitor medication adherence and adverse events. Follow-up visits occur every 3, 6, or 12 months after treatment ends to continue monitoring health outcomes.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.