Fairbanks

Researchers are evaluating treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous IV infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

Researchers are evaluating the addition of olaparib, a targeted therapy that blocks the PARP enzyme involved in DNA repair, in patients with pancreatic cancer who have had surgery to remove their tumor and carry a mutation in BRCA1, BRCA2, or PALB2. This phase II trial aims to determine if olaparib can improve relapse-free survival compared to placebo after chemotherapy completion. The study also explores overall survival and differences based on mutation type and chemotherapy received. Participants are randomly assigned to one of two groups. One group receives oral olaparib twice daily for 28-day cycles, up to 12 cycles, while the other group receives a placebo on the same schedule. Throughout treatment, patients undergo CT or MRI scans and blood collection. After treatment, patients are followed for up to 10 years with regular visits to monitor health and disease status. During the study, participants complete imaging scans and blood tests to assess disease progression and treatment effects. Researchers track relapse-free survival from the time of randomization until disease recurrence or death, with assessments extending up to 44 months. Safety and survival outcomes are monitored for up to 10 years. Follow-up visits occur 30 days after treatment and then every 4 months in the first year, followed by every 6 months for years 2 through 10.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are evaluating the effectiveness of computerized cognitive training methods to help breast cancer survivors who experience cognitive difficulties related to cancer and its treatments. This trial focuses on breast cancer survivors with non-metastatic disease who report cognitive problems after their cancer therapy, aiming to address the long-lasting challenges that affect their work and health. The study is a Phase III, double-blind, randomized controlled trial comparing two types of cognitive training methods. Participants will be assigned to one of two groups. The first group will use global stimulation games featuring non-speeded, strategy-based exercises like solitaire, sudoku, and word search that do not adapt to the players skill. The second group will use neuroplasticity games designed to improve cognitive functions such as attention, working memory, processing speed, and executive function, with exercises that adapt to the users performance. The training involves eight exercises tailored to address cognitive concerns common among breast cancer survivors. During the study, participants will be monitored over 12 weeks post-randomization for self-reported cognitive impairment, with further assessments extending to 36 weeks. Researchers will collect data through cognitive tests, questionnaires, and behavioral tracking within the programs to measure changes in cognitive performance. The trial will also evaluate the safety and adherence to the training programs, with the total participation period lasting up to 36 weeks from randomization.

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.

This research aims to collect data and samples from patients who experience side effects from immunotherapy used in cancer treatment. The goal is to better understand, predict, prevent, and treat these immune-related side effects, including serious adverse events, rare infections, or accelerated tumor growth. This observational study is led by the Alliance for Clinical Trials in Oncology and focuses on patients treated with immuno-oncology therapies who have experienced significant immune-related adverse events. Participants provide tissue and blood samples, with optional stool samples for those experiencing colitis, within 72 hours of confirming a serious immune-related adverse event and again one month later. The study also includes a review of patients medical records for up to one year. This approach helps establish a national biorepository of biospecimens and clinical data for future research. During the study, participants will undergo sample collection at two time points and have their medical history reviewed over a year. Researchers will monitor the establishment of the biorepository and collect clinical data to support future studies. This process aims to improve knowledge about immune-related side effects from immunotherapy and contribute to better patient care over time.

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 the impact of Promoting Community Conversations About Research to End Suicide PC CARES in rural Alaska Native communities to understand how this approach affects suicide prevention efforts. The study evaluates participant outcomes in learning circles, community-wide effects on youth, and how to sustainably expand PC CARES to other Alaska Native communities. It focuses on building personal and collective skills and tracking behaviors that support suicide prevention over time. The PC CARES intervention involves training local community health workers to lead up to five 3-hour Learning Circles over about six months. These sessions aim to create a community of practice among trusted adults to learn about, adapt, and apply suicide prevention best practices tailored to their culture and community. Participants attend sessions either virtually or in person, while a comparison group does not participate in the sessions but provides data at similar time points. Participants are involved in multiple assessments throughout the study, including surveys at baseline, after each Learning Circle session, and follow-ups at one and six months after the last session. These assessments measure changes in suicide prevention knowledge, self-efficacy, community collaboration, youth connectedness, social support, protective factors, and prevention behaviors. The study also gathers detailed feedback from student facilitators and community members to understand barriers and enablers to implementing PC CARES in remote communities. The total duration for participant involvement spans several months with multiple data collection points.

Researchers are studying the effects of social and genetic factors on the health outcomes of adolescent and young adult AYA cancer survivors who had Hodgkin or non-Hodgkin lymphoma. This observational study aims to understand how these factors influence disease-free survival, overall survival, and quality of life in this group, which faces unique risks compared to older or childhood cancer patients. The study also explores how gene expression changes might mediate these effects and considers the impact of race, gender identity, and location. Participants will complete questionnaires about their health-related quality of life and provide blood samples at the start of the study and then at 6, 12, 18, and 24 months. These activities will help researchers gather information on social-environmental risk factors, individual resilience, and biological changes. The study does not involve any treatment but focuses on monitoring and collecting data over two years. During the study, participants will be asked to complete quality of life questionnaires and give blood samples multiple times. Researchers will track disease-free survival, overall survival, and any other health complications up to two years. The study includes careful monitoring of participants health status and aims to provide insights that could help improve care for young cancer survivors. Participation requires internet access and the ability to complete forms in English, with informed consent obtained from each participant or their representative.

This research aims to assess colorectal cancer rates in participants aged 45 to 70 who have 1 to 2 non-advanced adenomatous polyps. The study compares the outcomes of surveillance colonoscopy performed once at 10 years versus twice at 5 and 10 years after the initial colonoscopy. Colorectal cancer is a common and serious disease, and while colonoscopy screening reduces its incidence, the best timing for follow-up exams after finding small non-advanced adenomas is unclear. Participants are randomly assigned to one of two groups one group receives surveillance colonoscopies at both 5 and 10 years after the qualifying colonoscopy, and the other group receives a single surveillance colonoscopy at 10 years. Colonoscopies follow standard quality guidelines and preparation instructions. All polyps found during the initial colonoscopy must have been completely removed for participants to be eligible. Throughout the study, participants will undergo colonoscopies according to their group assignment and will be monitored for the development of colorectal cancer over 10 years. Researchers will evaluate the incidence of colorectal cancer as the primary outcome. Participants adherence to scheduled colonoscopies and any additional procedures will be tracked. This study is designed to provide clear evidence on the optimal timing of surveillance colonoscopy after detection of small adenomas, informing future guidelines and clinical practice.