Fort Thomas

Researchers are evaluating the reliability and validity of two new assessments for post-traumatic stress disorder (PTSD) called the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5). They are comparing these new tools to the previous standard, the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV), in a study involving 950 active duty military personnel and veterans who have experienced traumatic events. The study also explores potential PTSD-related biomarkers, including biofluid, cognitive, physiological markers, and neural activity measured by EEG, to better understand and target treatments for PTSD. Participants will be randomly assigned to one of four study groups to test different aspects of the assessments. Groups 1 and 2 focus on test-retest reliability and response consistency over 12 weeks for CAPS-5 and PSSI-5. Group 3 tests the convergent validity of CAPS-5 against PSSI-5, and Group 4 compares CAPS-5 with CAPS-IV. The study uses these diagnostic interviews conducted at various times over up to 12 weeks to measure reliability and validity. During the study, participants will undergo interviews using the CAPS-5, PSSI-5, and CAPS-IV tools, with repeated assessments to check consistency and reliability. Researchers will collect data on PTSD symptoms and related biomarkers, and participants will complete screening for traumatic event exposure and PTSD symptoms. Outcomes measured include test-retest reliability scores, correlation of assessment results, and stability of symptom scores over time. The study aims to improve PTSD diagnosis and support future treatment development for military and veteran populations.

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.

Researchers are conducting a Phase 2 randomized, double-blinded, placebo-controlled adaptive platform trial to study treatments for Post Traumatic Stress Disorder (PTSD) in active-duty service members and veterans. This trial focuses on evaluating the safety, tolerability, and effectiveness of multiple potential drug treatments using a shared control group to compare interventions. One group in this trial is studying fluoxetine, a medication used to treat PTSD symptoms. Participants in the fluoxetine group will be randomly assigned to receive either fluoxetine or a placebo in a 5:3 ratio during a 12-week treatment period. Fluoxetine dosing starts at 10 mg daily for one week, then increases to 20 mg daily for two weeks, followed by 40 mg daily for two weeks, and then 60 mg daily for the remainder of the trial. Dose reductions are allowed once if needed for tolerability, but doses will not be increased after a reduction. The study includes a 30-day screening period before treatment and a 4-week safety follow-up after treatment. Participants will undergo evaluations including the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) to measure PTSD symptoms and the Columbia Suicide Severity Rating Scale (C-SSRS) to monitor suicidal thoughts or behaviors. These measures will be assessed at the end of the 12-week treatment or at early termination. Safety and tolerability will be closely monitored throughout the study. Total participation involves screening, treatment, and follow-up lasting approximately 16 weeks.

Researchers are conducting a Phase 2 adaptive platform trial to evaluate several potential drug treatments for Post Traumatic Stress Disorder (PTSD) in active-duty service members and veterans. This part of the trial focuses on studying daridorexant, assessing its safety and effectiveness compared to a placebo. The study design allows participants to be randomly assigned to different treatment groups, sharing a common placebo control for comparison. Participants who qualify under the Master Protocol undergo a 30-day screening period before being randomized into the daridorexant group or placebo group in a 5:3 ratio. Those receiving daridorexant take a 50 mg dose once daily, at least two hours after their last meal and within 30 minutes of going to bed. The treatment phase lasts 12 weeks, followed by a 4-week safety follow-up to monitor participants after treatment. Throughout the study, researchers measure changes in PTSD symptoms using the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) over 12 weeks. They also track any new or worsening suicidal thoughts or behaviors via the Columbia Suicide Severity Rating Scale (C-SSRS). The total study participation spans about 16 weeks, including screening, treatment, and safety monitoring periods.

Researchers are conducting a Phase 2 randomized, double-blinded, placebo-controlled trial to evaluate multiple potential drug treatments for Post Traumatic Stress Disorder (PTSD) in active-duty service members and veterans. This adaptive platform trial allows multiple treatment groups to be compared to a shared placebo control group, enabling efficient assessment of safety, tolerability, and effectiveness. The study also incorporates biomarker assessments to help define future participant groups based on biological markers, allowing a multi-stage testing approach including both non-biomarker and biomarker-defined cohorts. Participants will undergo a 30-day screening period, followed by a 12-week treatment period, and then a 4-week safety follow-up. The study includes up to five treatment arms, each testing a different drug or its matching placebo. Treatments include Fluoxetine hydrochloride, Vilazodone hydrochloride, Daridorexant, and SLS-002 administered according to specific dosing schedules ranging from daily oral doses to twice-weekly intranasal sprays. Dose adjustments for tolerability are permitted within predefined limits. New treatment cohorts can be added during the trial, and safety monitoring is overseen by an independent board. Throughout the study, participants will be assessed for changes in PTSD symptoms using standardized clinical scales and monitored for any new or worsening suicidal thoughts or behaviors. Procedures include blood draws, MRI scans, and various clinical evaluations. Data will be reviewed regularly to decide on continuing or stopping treatment arms. The total participant involvement spans approximately 16 weeks, including screening, treatment, and follow-up, with ongoing safety and biomarker analyses to guide future research directions.

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.

This research aims to compare the effects of usual care including regional radiation therapy with no regional radiation therapy in women with low-risk breast cancer. It focuses on patients with node positive breast cancer or T3N0 disease who typically receive endocrine therapy and possibly chemotherapy to prevent cancer recurrence. The study examines whether skipping regional radiotherapy still effectively prevents breast cancer from returning, potentially reducing unnecessary treatment and side effects. Participants will be divided into two groups: one receiving radiotherapy to the breast/chest area and surrounding lymph nodes, and the other receiving no regional radiotherapy. The study evaluates standard treatments, ensuring radiation therapy starts within specific time frames after surgery or chemotherapy. Treatments include breast-conserving surgery or mastectomy, along with endocrine therapy planned for at least five years. During the study, researchers will monitor breast cancer recurrence-free intervals over approximately 9.5 years. Participants will undergo regular assessments to track cancer status, side effects, and overall health. The study includes quality of life questionnaires for some patients and requires ongoing follow-up to document treatment effects, adverse events, and long-term outcomes.

Researchers are evaluating the effectiveness of using brain magnetic resonance imaging (MRI) scans alone compared to combining MRI scans with prophylactic cranial irradiation (PCI) in treating patients with small cell lung cancer (SCLC). This phase III trial aims to determine if MRI surveillance alone is not worse than adding PCI in terms of overall survival. The study also looks at cognitive function, brain metastasis-free survival, and treatment side effects among patients with limited or extensive-stage SCLC. Participants are randomly assigned to one of two groups. One group receives PCI, which is radiation therapy focused on the brain, given over two weeks for 20 minutes per day, five days a week, along with scheduled MRI scans at 3, 6, 9, 12, 18, and 24 months. The other group undergoes MRI scans at the same intervals without receiving PCI. Both groups are monitored closely through these MRI scans to track any spread of cancer to the brain. During the study, patients will have regular MRI scans, cognitive assessments, and evaluations of side effects and survival outcomes up to two years after randomization. Blood samples will be collected for future research. Researchers will monitor overall survival, cognitive failure rates, and brain metastasis occurrence, aiming to understand if avoiding PCI might reduce side effects without compromising survival. Participant involvement includes multiple scheduled scans and tests over a two-year follow-up period.

Researchers are evaluating targeted treatments for men with metastatic castration-resistant prostate cancer (mCRPC) to see if genetic testing can help assign the most appropriate therapy. This phase II trial focuses on analyzing cancer tissue samples for DNA and RNA abnormalities to guide treatment decisions. The study aims to measure how well patients respond to treatments based on genetic profiles and to assess safety, progression-free survival, and overall survival outcomes. Participants are assigned to one of three treatment arms determined by genetic testing results and a molecular tumor board decision. Arm A receives valemetostat tosylate orally daily in 28-day cycles. Arm B receives carboplatin and cabazitaxel intravenously every 21 days. Arm C receives one of several regimens including cabazitaxel IV, abiraterone acetate with prednisone orally, enzalutamide orally, or lutetium Lu 177 vipivotide tetraxetan IV with varying cycle lengths and durations. All patients undergo imaging scans such as MRI, CT, and bone scans, with optional PET scans and blood collections throughout the trial. During the study, patients are closely monitored through imaging and lab tests to assess tumor response and adverse effects. After treatment ends, those without disease progression are followed every 2 months for 6 months, then every 3 months up to 5 years; patients with progression have follow-up every 6 months for 5 years. The primary outcome is objective tumor response within 6 months, while secondary outcomes include safety, progression-free survival, PSA response, time to progression, overall survival, and patient-reported outcomes.

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.