Manhattan

Researchers are collecting and storing tissue and blood samples from patients with various types of cancer to create models that help study cancer and test new treatments. This observational study focuses on patients with confirmed or suspected cancer diagnoses, including solid tumors and hematologic malignancies, to improve laboratory research and drug development. The study involves obtaining tumor tissue and blood samples during medically necessary procedures related to the patient's cancer treatment. These samples will be preserved using xenograft models (transplantation into another species) or cell cultures for future analysis. Sample collection is timed carefully around treatment cycles to ensure tissue viability. Participants will undergo tissue and blood collection as part of their clinical care, with no additional procedures solely for the study. Researchers will review pathology and flow cytometry reports to confirm viable cancer cells in the samples. The main outcome is the successful procurement and storage of these biological materials for research over a follow-up period of up to five years.

Researchers are evaluating a data coaching process called Out of School Time Coach (OST-Coach) to see if it can improve children's physical activity, their confidence in motor skills, and the physical activity practices of staff in after-school programs. The study aims to measure whether this targeted coaching system increases the amount of physical activity children engage in and enhances their perceived motor competence compared to usual practices. Additionally, the study will assess if staff at intervention sites adopt more physical activity-promoting behaviors during after-school programming. The OST-Coach intervention consists of four data coaching sessions conducted over an academic year. Each session includes a customized data report for the site, goal setting, and strategies focused on increasing child physical activity, motor competence, and staff physical activity-promoting behaviors. This behavioral intervention is delivered at the staff level with feedback provided four times throughout the school year. Participants will be involved throughout the academic year while attending elementary-level after-school programs. Child physical activity will be measured using systematic observation and surveys assessing perceived motor competence. Staff behaviors promoting physical activity will also be observed and evaluated through surveys. The study measures child physical activity through to its completion at one year, monitoring changes in both child behavior and staff practices to understand the impact of the coaching process.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are investigating whether nature-based physical activity can help improve symptoms of depression and anxiety in adults. This phase 2 pilot study involves therapists and their clients, focusing on how outdoor walk-and-talk therapy combined with goal-setting for outdoor activity might affect mental health. The study prioritizes enrolling clients from underrepresented minority groups and aims to measure changes in depression, anxiety, and physical activity in natural settings. The study includes ten licensed therapists in northeast Kansas who will receive a 3-hour training on the intervention and study procedures. Each therapist will recruit six clients aged 18 to 65 with diagnosed depressive or anxiety disorders who can safely engage in moderate physical activity. Clients will be randomly assigned to either the intervention group, participating in weekly outdoor walk-and-talk therapy with weekly goal-setting and progress check-ins, or to an active waitlist control group receiving usual care and information on nature-based physical activity. Both groups will use a Fitbit and the NatureDose app to track physical activity and time spent in nature during the 10-week study. Participants will complete surveys on depression and anxiety at the start and end of the 10-week intervention. Therapists will log the frequency and duration of therapy sessions weekly, while clients will track their outdoor activity and use the app daily. At the end, clients will complete a satisfaction survey, and therapists will be interviewed. The primary outcomes include participation in therapy sessions, perceived therapist support for nature-based activity, and acceptability of the intervention over the 10 weeks.

Researchers are evaluating a phase III trial comparing shorter chemo-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer (TNBC). This study focuses on whether the anthracycline-free treatment combined with pembrolizumab is at least as effective as the standard anthracycline-containing regimen in preventing breast cancer events. The trial also examines various secondary outcomes including pathological response, survival rates, safety, tolerability, patient-reported quality of life measures, and translational objectives related to tumor immune markers. Participants are randomly assigned to one of two treatment groups. The first group receives paclitaxel, carboplatin, and pembrolizumab intravenously followed by doxorubicin, cyclophosphamide, and pembrolizumab before surgery. The second group receives docetaxel, carboplatin, and pembrolizumab intravenously before surgery. After surgery, patients in both groups may continue pembrolizumab treatment. Blood samples may be collected throughout the trial for additional analyses. During the study, participants undergo multiple assessments including imaging, blood tests, and physical exams before starting treatment. Patient-reported outcomes such as fatigue and physical function are collected through questionnaires. Follow-up visits occur every six months for two years, then annually up to five years to monitor breast cancer event-free survival and overall health. Safety and quality of life are continuously evaluated, and banking of physical specimens is performed for future research.

This research aims to understand how a science-based mobile app called Flourish affects the well-being of students. It focuses on whether access to the app can improve feelings such as positive mood, loneliness, and belonging, and whether using the app together with a human buddy leads to better outcomes compared to using the app alone. The study is a multi-institutional, randomized controlled trial involving healthy students. Participants will be randomly assigned to one of three groups: a waitlist control group that continues with existing school resources, a group using the Flourish app twice per week, or a group using the Flourish app twice per week alongside a "Flourish Buddy." The app offers a digital toolkit and an AI chatbot designed to support mental well-being. During the 6-week study period, participants will complete four online surveys assessing various aspects of well-being, including mood, loneliness, social support, mindfulness, resilience, and flourishing. Researchers will measure these outcomes at the start, during, and at the end of the study to evaluate the app's impact and participant retention. The total participation lasts six weeks with assessments occurring throughout.

Researchers are evaluating whether adding pembrolizumab, a type of immunotherapy, to usual chemotherapy improves outcomes in patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been removed by surgery. Pembrolizumab may help the immune system attack cancer cells and prevent tumor growth. Chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel work by stopping tumor cells from growing and spreading. This phase III trial compares disease-free survival between different treatment approaches involving pembrolizumab and chemotherapy. Participants are randomly assigned to one of two treatment groups. In Arm B, patients receive four cycles of chemotherapy followed by pembrolizumab given intravenously every 21 days for up to 17 cycles or every 6 weeks for 16 cycles. In Arm C, patients receive chemotherapy combined with pembrolizumab during the initial four cycles, followed by pembrolizumab alone for up to 13 cycles every 21 days or 12 cycles every 6 weeks. Chemotherapy regimens include various platinum doublets chosen by the treating physician. Arm A was closed as of February 2022. Patients may also undergo tests such as echocardiograms, MRIs, CT scans, and blood sample collections during the trial. Throughout the study, participants are monitored with regular assessments including imaging and blood tests. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years after randomization. Researchers measure disease-free survival, overall survival, adverse events, drug discontinuation rates, and patient quality of life using questionnaires. The study also explores outcomes based on tumor markers like PD-L1 expression and tumor mutational burden.

Researchers are evaluating the combination of cabozantinib, nivolumab, and ipilimumab to treat patients with rare genitourinary tumors that have spread from their original location to other parts of the body. This phase II trial aims to measure how effective this combination is by looking at tumor response rates and survival outcomes. The study also assesses safety and supports tissue banking and clinical follow-up to better understand these rare cancers, including specific evaluation for patients with bone-only disease. Participants receive cabozantinib orally once daily during the first four cycles on a 21-day schedule and then continuously on a 28-day schedule for subsequent cycles. Nivolumab and ipilimumab are given intravenously on day 1 of cycles 1 to 4, followed by nivolumab alone on day 1 of later cycles. Treatment continues for up to 2 years unless the disease progresses or side effects become unacceptable. Patients may undergo several imaging tests such as CT, MRI, bone scans, PET/CT, and echocardiography throughout the study. During the trial, patients provide blood and urine samples regularly and undergo imaging to monitor disease status and treatment effects. Researchers track tumor response, progression-free survival, overall survival, and clinical benefit rates. After finishing treatment, participants are followed every two months for up to five years to observe long-term outcomes and safety.

Researchers are evaluating a combination therapy for adults with newly diagnosed multiple myeloma, a type of plasma cell cancer. This phase III trial compares a four-drug combination including daratumumab, bortezomib, lenalidomide, and dexamethasone to a three-drug combination without bortezomib. The study aims to determine if adding bortezomib improves overall survival, especially in patients with minimal residual disease (MRD), while also assessing side effects, progression-free survival, and patient-reported outcomes related to quality of life and neuropathy. Treatment begins with a standard induction phase where all patients receive daratumumab subcutaneously, lenalidomide orally, and dexamethasone orally over nine 28-day cycles. After induction, patients are randomized to receive consolidation therapy either with the four-drug combination including bortezomib or the three-drug combination without bortezomib for nine additional 28-day cycles. Following consolidation, maintenance therapy with daratumumab and lenalidomide is given in repeated 28-day cycles until disease progression or unacceptable side effects occur. The study also incorporates imaging and biomarker assessments to evaluate treatment response and risk. Participants undergo regular evaluations including blood tests, bone marrow biopsies, and imaging scans to monitor disease status and treatment effects. Patient-reported questionnaires assess quality of life and symptoms such as neuropathy. After treatment, follow-up visits occur every three months for up to two years, then every six months for three years, and annually thereafter for up to 15 years. The primary outcome measured is overall survival from the time of randomization to the date of death or last known alive status.

Researchers are studying if repeated transcranial magnetic stimulation (rTMS) can help treat stuttering in adults aged 18 to 65 years. The study aims to see if the treatment causes changes in brain activity and whether these changes reduce stuttering. It focuses on people who stutter and examines brain function and speech behavior before and after treatment. Participants receive structural and resting-state functional MRI scans to guide the placement of the TMS coil. The rTMS treatment is delivered at 10 Hz for 10 minutes at 120% of the resting motor threshold, targeting the left inferior frontal gyrus. The study includes 10 sessions of rTMS administered using neuronavigation to ensure precise stimulation. Before treatment, participants attend three lab visits for baseline testing, and after treatment, they attend two visits for follow-up assessments. During each lab visit, brain activity is recorded using resting-state EEG for 5 minutes while the participant's eyes are open. Eye-tracking measures are taken as participants complete phonological memory tasks, and spontaneous speech samples are collected to measure the percentage of stuttered syllables. Researchers monitor changes immediately after treatment and one week later, focusing on brain connectivity and stuttering behavior. Participation involves multiple tests to assess both brain function and speech outcomes throughout the study period.