Cancer Prevention

Colorectal cancer is a common and serious disease that often develops from precursor growths called adenomatous polyps. This study evaluates the long-term effects of berberine hydrochloride, a drug previously shown to reduce recurrence of these polyps after removal. Researchers aim to see if the protective effects of berberine continue for up to six years after patients stop taking the medication. The study observes patients who were part of an earlier trial where they received either berberine or a placebo. It compares the recurrence rates of colorectal adenomas and other types of polyps at multiple intervals: within the first year, between one and three years, and between three and six years after stopping the drug. This retrospective follow-up helps assess berberine's long-term preventive effects. Participants will be monitored through medical records to track the recurrence of colorectal adenomas and other polyps over six years. Researchers will analyze outcomes such as the rate of traditional adenoma recurrence and the incidence of hyperplastic and serrated polyps. This study provides important information about the lasting impact of berberine on colorectal polyp recurrence after endoscopic removal.

Researchers are studying whether treatment decision-making can be improved for smokers who have difficulty quitting with medications. This trial focuses on smokers seeking to quit and evaluates adaptive treatment strategies using FDA-approved options. The goal is to find the best approach for each person by adjusting the treatment based on early response to medications. The study is sponsored by the Medical University of South Carolina and is designed as a randomized clinical trial without masking. Participants will receive a free 12-week course of nicotine replacement therapies (patches and lozenges), varenicline, or e-cigarettes as harm reduction products. Initially, smokers are randomized to either varenicline or combination NRT for four weeks. Those showing early success continue the same medication, while non-responders may switch to the other medication or continue the same one, with further adjustments made at weeks 4 and 8. After 12 weeks, no more products are provided. All study visits and assessments are conducted remotely through phone calls and surveys. Participants will complete eight surveys over six months, including a follow-up survey six months after the initial call. Researchers will measure smoking cessation success and dependence outcomes, with primary outcomes assessed at 8 weeks and final outcomes at 24 weeks. The study allows for safety monitoring throughout and involves no in-person visits.

Researchers are addressing racial disparities in colorectal cancer (CRC) by focusing on African Americans aged 45 to 75, who face higher CRC incidence and mortality and lower screening rates. The study aims to improve CRC screening by partnering with the Department of Motor Vehicles (DMV) to recruit 1,200 African American participants during their DMV visits. The research compares two approaches to increase screening: on-site distribution of Fecal Immunochemical Test (FIT) kits and on-site distribution combined with targeted social media advertising. Participants will receive a free FIT kit with a prepaid return envelope, a culturally tailored educational brochure, reminder text messages, and phone calls. The social media group will see targeted ads on Facebook, Instagram, and YouTube from August to October 2024. Participants return kits to a Nebraska Medicine lab, and results are mailed within 14 to 21 days. For those with positive results or lacking insurance or a primary care provider, a health navigator provides help with scheduling follow-up colonoscopies and accessing financial support. Throughout the study, participants provide demographic and screening information via surveys. Researchers measure FIT kit return rates, positive test rates, and follow-up colonoscopy completion rates, comparing the two groups while considering factors like age, gender, income, and health beliefs. Participants' perceptions about screening are also gathered through an online survey. The study runs until October 2026, with ongoing monitoring of screening completion and follow-up outcomes.

Researchers are studying patients who have cancer or may be at risk of developing cancer to improve the standard of care. This observational study collects blood, tissue, and other biological samples along with associated data such as surveys, medical records, and cancer registry information. The goal is to enable new clinical trials, technology advancements, and personalized medicine for cancer patients over time. Participants provide consent to allow collection and storage of their biological samples and data. This includes blood and tissue samples as well as survey assessments and medical chart reviews. The study does not involve treatment but focuses on gathering information to support cancer research and care improvements. During the study, patients' biological samples and data are collected and stored long-term. Researchers analyze survey responses, medical records, and biological specimens to measure outcomes related to improving cancer care standards. The study follows participants for up to 20 years, aiming for a lifetime partnership to support ongoing cancer research and care advancements.

Childhood obesity is a growing global health concern linked to serious health problems such as type 2 diabetes, high blood pressure, certain cancers, and mental health challenges. Researchers are evaluating a digital support system called Evira to help improve treatment outcomes for children with obesity. This randomized controlled study aims to assess the effects of adding Evira to the usual lifestyle treatment for childhood obesity in children aged 4 to 17 years. The study compares two groups: one receiving Evira Care combined with standard lifestyle treatment, and the other receiving standard lifestyle care alone. Evira Care involves daily weight monitoring at home using a special scale connected to a mobile app and website, allowing parents and clinicians to track weight changes and communicate easily. The intervention group will receive guidance on how to use the system and make feasible lifestyle changes, with weight targets set for the first three months. The control group continues with standard care without restrictions on visits or clinical support. Participants will be involved for 12 months, undergoing clinical exams including puberty assessment, cardio-respiratory, thyroid, skin, and abdominal checks, along with measurements of weight, height, and blood pressure. Blood tests may be done as needed. All participants will complete questionnaires about quality of life, eating disorders, and treatment satisfaction. Researchers will monitor weight change as the primary outcome, along with treatment compliance and psychosocial health measures, while collecting information on any side effects.

Gastrointestinal (GI) cancers, including hepatocellular carcinoma, cholangiocarcinoma, pancreatic ductal adenocarcinoma, esophageal squamous cell carcinoma, gastric cancer, and colorectal cancer, continue to be a significant global health concern. This research aims to develop a noninvasive screening test using circulating microRNAs (miRNAs) to better detect these cancers early. Current methods like endoscopy and imaging are invasive or less sensitive, making early diagnosis difficult and limiting treatment options. The study seeks to create a cost-effective and practical miRNA signature to improve early detection and outcomes for patients. This study uses a retrospective international cohort of blood samples from patients with various GI cancers and non-cancer controls, including healthy volunteers and those with benign conditions. Small RNA sequencing will identify miRNA profiles, and advanced machine learning methods will be applied to develop a miRNA panel that can distinguish cancer from non-cancer cases and differentiate among cancer types. The study includes discovery, modeling, and validation phases across multiple centers and diverse populations to ensure the panel's accuracy and reliability. Participants contribute by providing blood samples collected before treatment, and researchers will analyze these samples along with clinical and demographic data. The study will assess the diagnostic accuracy of the miRNA panel at baseline, focusing on its ability to detect early-stage cancers and distinguish cancer subtypes. This observational study involves no treatment interventions, and participation mainly consists of data and sample analysis. The study is expected to continue until June 2026, with ongoing monitoring of the miRNA panel's performance.

Researchers are studying the effects of a low-protein diet on cancer patients receiving immunotherapy treatments. The study aims to see if reducing protein intake can change the tumor environment and boost the body's immune response, potentially enhancing the effects of immune checkpoint inhibitors. This is a randomized, open-label study conducted at a single center to explore the feasibility of this dietary approach. Participants will be randomly assigned to one of two groups: one receiving immunotherapy plus a control diet containing about 20% protein, and the other receiving immunotherapy combined with a low-protein diet containing 10% protein. The study intervention lasts for 4 months, during which the dietary impact on immune response and treatment effects will be evaluated. Throughout the 4-month study period, participants will be monitored for their ability to follow the dietary plan and for any changes in immune response to immunotherapy. Researchers will assess safety, tolerability, clinical efficacy using RECIST v1.1 criteria, and enrollment and drop-out rates. Laboratory tests and imaging scans will also be conducted to evaluate disease progression and treatment impact.

Researchers are studying the effects of intermittent caloric restriction combined with a plant-based diet in cancer patients receiving chemotherapy. This pilot trial aims to assess whether this dietary approach is feasible and safe alongside standard chemotherapy, and whether it may reduce side effects while potentially enhancing the chemotherapy's antitumor effects. Participants will follow a protocol involving alternate-day intermittent caloric restriction along with a plant-based protein diet during their chemotherapy treatment. The study evaluates how this combined dietary intervention interacts with standard chemotherapy regimens over the course of treatment. During the study, participants will be monitored for adherence to the dietary plan and chemotherapy treatment. Researchers will assess feasibility over 12 months, including safety and preliminary evidence of clinical efficacy. Evaluations may include health assessments, laboratory tests, and monitoring of side effects throughout the study period.

Researchers are conducting a phase I clinical trial to explore a new type of cancer vaccine called the polyphenol whole tumor cell vaccine for patients with advanced malignant solid tumors. These tumors include cancers originating in epithelial, mesenchymal, or nervous tissues. The study aims to find the effective dose, assess safety and tolerability, and ultimately provide new treatment options to help control the disease long-term. This vaccine is based on previous promising research that showed enhanced immune responses and tumor suppression in animal models. The trial involves administering the polyphenol whole tumor cell vaccine at different dose levels to small groups of patients using a "3+3" dose escalation design. Patients receive five doses of basal immunization on days 0, 14, 28, 42, and 56, followed by individualized treatments of one dose per month for four months, depending on tumor assessment. The vaccine includes tumor cells coated with plant polyphenols and uses bacterial lipopolysaccharide as an adjuvant to stimulate the immune system against multiple tumor antigens. Participants will be closely monitored throughout the study for safety and side effects from the first dose until 14 days after the last vaccination. Researchers will also evaluate tumor response, progression-free survival, and overall survival over about one year. The study includes thorough assessments of organ function, blood tests, and tumor measurements. The trial is expected to last until the end of 2026 and aims to provide important information on the vaccine's safety and preliminary anti-tumor activity in patients with advanced solid tumors.

Researchers are evaluating whether an online mindfulness program can reduce and prevent mood and anxiety symptoms in adolescents who are at risk due to high levels of trait negative affect, a tendency to experience frequent and intense negative emotions. This randomized clinical trial compares the mindfulness program to a supportive comparison group and a no-intervention control group. The study focuses on reducing momentary negative emotions and internalizing problems in youth aged 12 to 17 years old. Participants are randomly assigned to one of three groups: the Mindfulness Program, the Supportive Active Comparison, or a Control group. The Mindfulness Program involves nine weekly 30-minute online sessions with a coach teaching mindfulness skills like calm breathing and gratitude. The Supportive Active group also meets weekly online with a coach to discuss personal thoughts and feelings, using active listening and expressive writing. The Control group completes assessments only at the same time points as the other groups. Participants will be assessed before the intervention, after the 9-week program, and again at a six-month follow-up. Assessments include measures of momentary negative affect and internalizing symptoms using ecological momentary assessment and diagnostic evaluations. The study aims to understand how mindfulness training affects emotional regulation and the development of anxiety and depression symptoms in vulnerable youth over time.