Wilmington

Researchers are evaluating a culturally-tailored, home-based physical activity program designed to improve physical fitness in Hispanic or Latino/Latina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects such as weight gain, fatigue, and reduced fitness after cancer treatment, with Hispanic or Latino/Latina individuals potentially at higher risk. The study aims to increase moderate to vigorous physical activity (MVPA) through a mobile health and social media intervention. The study has two stages. Stage 1 involves developing the intervention using feedback from 20 Latinx survivors who speak either English or Spanish. Stage 2 is a randomized controlled trial comparing the intervention group with a control group that only uses a Fitbit tracker. The intervention group receives Fitbit trackers, weekly reminders, goal-setting sessions, social media peer support 2-3 times a week, badges, monthly Zoom meetings, and may choose a physical activity partner who also receives support. After 12 weeks, a 4-week maintenance phase continues these supports with less structure. The control group wears a Fitbit daily for 12 weeks without additional support. Participants wear Fitbit trackers daily, attend weekly sessions, post on social media, and complete interviews and questionnaires. Researchers measure changes in physical activity levels, sedentary time, quality of life, and cardiometabolic health indicators. Data is collected using Fitbit devices, interviews, and surveys, with follow-up over 12 weeks plus maintenance. Safety and acceptability of the intervention are also assessed throughout the study.

This research involves both pediatric and adult patients with various blood-related cancers and other disorders affecting the blood and immune system. It focuses on using unlicensed cryopreserved cord blood units (CBUs) for transplantation, aiming to study how well these unlicensed CBUs support recovery after transplant. The study also looks at important outcomes such as infection transmission, infusion reactions, survival rates, and graft-versus-host disease. Participants will receive transplants using these unlicensed cord blood units as part of a multicenter access and distribution protocol. The study is conducted at multiple U.S. transplant centers under the care of transplant physicians. The transplantation process involves administering these CBUs to patients with hematologic malignancies and other relevant conditions. Patients will be monitored for neutrophil recovery at 60 and 100 days post-transplant to assess engraftment success. Researchers will also evaluate infection rates, serious infusion reactions, survival one year after transplant, and incidences of acute and chronic graft-versus-host disease. Platelet recovery will be tracked as well. The study involves regular assessments to follow patients’ health and transplant outcomes over time.

Researchers are studying children with Hypochondroplasia, a genetic condition affecting growth, to observe how their growth changes over time and to understand the clinical course of this condition. The study gathers detailed growth measurements and other important health variables to track development. This is an observational study conducted across multiple centers and countries, focusing on children up to 15 years old with confirmed genetic diagnosis of Hypochondroplasia. The study does not involve active treatments but monitors participants regularly over a long period, up to 15 years. Every six months, various growth measurements are taken, including annualized growth velocity, height, body mass index (BMI), and ratios of different body segments such as upper to lower body, leg length ratios, and arm span to height. These detailed assessments help track changes in physical growth and body proportions over time. Participants will attend scheduled visits every six months for up to 15 years, during which researchers will measure and record growth parameters and body ratios. The study aims to capture changes in growth patterns and body measurements continuously throughout the study period. No specific interventions are given, but the study carefully monitors participant growth and development to better understand Hypochondroplasia and its effects on children.

Researchers are evaluating the effectiveness of pemigatinib in adults with advanced or metastatic pancreatic cancer that has spread to nearby tissues, lymph nodes, or distant body parts, and that have specific genetic changes in the FGFR gene. The study focuses on patients whose cancer has FGFR2 gene fusions or other FGFR alterations, aiming to see if pemigatinib can block these abnormal gene functions to stop tumor growth and possibly improve quality of life. This is a phase II trial conducted nationwide using a fully decentralized telemedicine approach to reach participants. Participants receive pemigatinib as an oral medication once daily for 14 days within each 21-day cycle. Treatment continues unless the disease progresses or unacceptable side effects occur. Alongside the drug treatment, patients undergo various imaging tests including CT scans, MRI, optical coherence tomography (OCT), and when needed, whole body bone scans and dilated eye exams (ophthalmoscopy). After finishing treatment, patients are followed up at 30 days and then every four months for one year to monitor their condition. Throughout the study, patients provide blood samples and undergo scans to evaluate treatment response and detect resistance mutations. Researchers track the overall response rate for up to 24 months and assess safety and tolerability. Patients must comply with scheduled visits, tests, and oral medication intake. The total study participation includes treatment cycles and a follow-up period lasting up to approximately 16 months after treatment completion.

Researchers are studying adolescents and young adults aged 13 to 21 with sickle cell disease (SCD) to evaluate the effects of SCThrive, a behavioral self-management program, on patient activation, self-management behaviors, daily functioning, and emergency room visits. The study compares SCThrive to a standard care program called SCHealthED, which includes educational text messages. The goal is to see if SCThrive improves these outcomes and if improvements last three months after treatment ends. Participants are assigned to either SCThrive, an 8-week virtual group program with a companion mobile app encouraging daily use, or SCHealthED, which provides standard care plus seven educational text messages about SCD. SCThrive includes added app engagement strategies and addresses social and health barriers. Both groups receive care at one of four pediatric sickle cell clinics. During the study, participants complete surveys on self-management before treatment, immediately after the 8-week program, and three to four months later. Researchers measure patient activation, self-management behaviors, daily functioning, and emergency room visits. The study tracks these outcomes to assess the effectiveness of SCThrive and monitors participant progress through regular assessments over several months.

Researchers are investigating how patterns of blood cell growth called therapy-related clonal hematopoiesis (t-CH), which involve mutations linked to cardiovascular disease (CVD), relate to heart health in patients treated for classical Hodgkin Lymphoma during childhood or adolescence. The study aims to assess how common these blood cell mutations are in patients exposed to anthracycline chemotherapy and how these mutations associate with signs of heart disease detected by cardiac MRI. The research also explores whether factors such as radiation treatment, patient characteristics, and clinical risk factors influence the presence of t-CH and its impact on heart health over time. Participants undergo several procedures including blood sample collection, retrieval of archived blood samples if available, medical record review, completion of surveys, and cardiac magnetic resonance imaging (MRI) without sedation. The study compares rates of t-CH mutations and cardiovascular findings between groups with and without clinical risk factors or radiation exposure. This is an observational study where all treatment has been completed at least two years prior to enrollment. Throughout the study, researchers collect data from blood tests, MRI scans, surveys, and medical records to monitor the presence of t-CH mutations and objective signs of cardiovascular disease. The primary outcome focuses on the detection of therapy-related clonal hematopoiesis with mutations linked to heart disease over one year. Participants must be able to undergo cardiac MRI without sedation and have access to the imaging at the enrolling institution. The goal is to better understand heart health risks in Hodgkin Lymphoma survivors to enable closer monitoring and early intervention if needed.

Researchers are evaluating two forms of buprenorphine treatment for Veterans with moderate to severe opioid use disorder (OUD). This Phase 4, open-label, randomized controlled trial aims to compare a 28-day injectable subcutaneous buprenorphine formulation at a target dose of 300 mg with the standard daily sublingual buprenorphine dose ranging from 4 to 32 mg. The study will recruit 952 Veterans over seven years and follow them actively for 52 weeks, with additional passive follow-up via medical records for up to 10 years. The study also explores secondary outcomes including other substance use, overdose incidents, infections like HIV and hepatitis, incarceration, quality of life, mental health symptoms, housing, dental health, and cost-effectiveness. Participants will begin induction on daily sublingual buprenorphine using standard guidelines to reach a target dose between 4 and 32 mg within 45 days. After reaching this dose, participants are randomly assigned to either continue daily sublingual buprenorphine with naloxone, prescribed in 28-day take-home supplies, or receive monthly injectable buprenorphine administered in the clinic. Both treatment groups have visits at weeks 1, 2, 3, and 4 post-randomization, then every two weeks until week 52, with medication management provided at each visit. During the study, participants will provide self-reports of opioid abstinence and undergo urine drug screenings every two weeks. Medication adherence and retention in treatment are tracked approximately every four weeks. After the active 52-week period, participants will be followed passively through electronic medical records for up to 10 years to monitor long-term outcomes. This comprehensive approach aims to assess the effectiveness and safety of these treatments for opioid use disorder in Veterans.

This research aims to understand the safety, effectiveness, and overall treatment experience of participants prescribed BRIUMVI4 (ublituximab-xiiy) in a real-world setting. The study focuses on people living with relapsing multiple sclerosis (RMS), a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms. It is designed to gather detailed insights from actual use outside of controlled clinical trials. Participants in this study are those who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. There is no intervention assigned by the study itself; instead, it observes the outcomes and experiences of patients treated with BRIUMVI4 as part of their routine care over time. Throughout the study, researchers will track the annualized relapse rate (ARR) up to week 96 to measure disease activity. Participants' safety, treatment adherence, and experiences will be evaluated through regular monitoring, including any adverse events. The total duration of participation covers up to 96 weeks, allowing for a comprehensive understanding of long-term treatment effects and patient-reported outcomes.

Researchers are investigating the best way to combine chemotherapy and radiation therapy based on how patients with localized non-germinomatous germ cell tumors (NGGCT) in the brain respond to initial chemotherapy. This phase II study aims to optimize radiation treatment for those who respond well to induction chemotherapy to reduce spinal cord relapses, and to use higher dose chemotherapy followed by conventional radiation for patients who do not respond as well. The study evaluates various chemotherapy drugs that work to stop tumor growth in different ways and uses radiation therapy with high-energy x-rays or protons to kill tumor cells and shrink tumors. Participants receive induction chemotherapy with drugs including carboplatin, etoposide, ifosfamide, and thiotepa over multiple cycles. Based on their response, patients are assigned to one of two treatment plans: those with a good response receive whole ventricular plus spinal canal irradiation (WVSCI) radiation therapy, while those with less favorable responses may receive high-dose chemotherapy with peripheral blood stem cell transplantation followed by radiation therapy. Some patients may also undergo second-look surgery depending on their tumor response. Treatments are carefully scheduled and monitored for up to six weeks for radiation and multiple cycles for chemotherapy. During the study, participants undergo regular assessments including MRI scans, cerebrospinal fluid and blood sample collections, and neurocognitive and quality of life evaluations. Researchers monitor tumor response, progression-free survival, overall survival, and treatment side effects for up to 10 years after treatment. Additional evaluations compare outcomes based on radiation type and assess growth and blood counts in younger patients. Patient safety and treatment effectiveness are closely followed throughout the study period.

Researchers are evaluating combination chemotherapy treatments for patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) and relapsed favorable histology Wilms tumors (FHWT). This phase II trial aims to assess how adding vincristine and irinotecan to standard chemotherapy regimens affects event-free survival and overall survival compared to historical data. The study also explores kidney toxicity, tumor genetics, and radiation therapy techniques to reduce side effects in children with lung and liver metastases. Two chemotherapy regimens are studied. Arm I (Regimen UH-3) involves cycles of vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan given intravenously on specific days every 21 days. Radiation therapy is given around week 7 of cycle 3 if needed. Arm II (Regimen ICE/Cyclo/Topo) includes cycles of ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan given intravenously every 21 days, with surgery and/or radiation during certain cycles. Both arms include multiple cycles in absence of disease progression or unacceptable side effects. Participants undergo various scans like CT, PET, MRI, chest x-rays, ultrasounds, and bone scans throughout the trial. Blood samples and biopsies may be collected periodically. After treatment, patients are followed up every 3 months for the first 2 years, every 6 months for years 3-4, and once at year 5. The main outcomes measured are event-free survival and overall survival up to 5 years, along with monitoring kidney health and treatment effects.