Fort Thomas

Researchers are evaluating the reliability and validity of two new PTSD assessment tools, the Clinician Administered PTSD Scale for DSM-5 CAPS-5 and the PTSD Symptom Scale Interview for DSM-5 PSSI-5, in active duty military personnel and veterans aged 18 or older who have experienced traumatic events. The study also compares these new tools to the previous standard, the CAPS-IV, while exploring biomarkers related to PTSD such as biofluid markers, cognitive and physiological indicators, and brain activity measured by EEG. This research aims to improve diagnosis and treatment approaches for PTSD in this population. Participants are randomly assigned to one of four cohorts. Cohorts 1 and 2 focus on test-retest reliability of CAPS-5 and PSSI-5 respectively, with participants completing between two and seven visits some continue with additional visits including cognitive, behavioral assessments, and biofluid sample collection. Cohort 3 compares CAPS-5 and PSSI-5 through three visits, while Cohort 4 compares CAPS-IV and CAPS-5 over three visits, including similar assessments and sample collections. The study uses multiple visits and assessments to thoroughly evaluate the consistency and validity of these diagnostic tools. During the study, participants undergo multiple office visits where they complete PTSD assessments, cognitive and behavioral tests, and provide biofluid samples. Researchers measure test-retest reliability over intervals of about one week and six weeks, and correlations among the different PTSD assessments. Safety and mental health status are monitored throughout. The total involvement may range from two to seven visits depending on cohort and group assignment. The study collects detailed data to better understand PTSD diagnosis and related biomarkers in veterans and active duty military members.

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

Researchers are studying colorectal cancer CRC in participants aged 45 to 70 who have 1 to 2 non-advanced adenomas, which are small colon polyps without high-risk features. The trial compares two surveillance colonoscopy schedules one group receives colonoscopy at 5 and 10 years after polyp detection, while the other group has colonoscopy only at 10 years. This study aims to provide randomized data to guide optimal timing for follow-up colonoscopies to help reduce CRC incidence and improve clinical practices. Participants are randomly assigned to one of two groups the first group undergoes surveillance colonoscopy at both 5 and 10 years following their qualifying colonoscopy, and the second group undergoes colonoscopy at 10 years only. All colonoscopies, including any unscheduled ones, follow current quality guidelines and institutional preparation standards. The qualifying colonoscopy must have been complete and performed within 4 years before randomization, with all polyps fully removed. During the study, participants will undergo colonoscopies according to their assigned schedules. Researchers will monitor the incidence of colorectal cancer over 10 years as the primary outcome. Participants must be able to understand English or Spanish to complete required procedures. The study may last up to several decades, with ongoing monitoring to assess long-term cancer incidence and the effectiveness of different surveillance intervals.

Researchers are evaluating targeted treatments for metastatic prostate cancer by using genetic testing to guide therapy choices. This phase II trial studies whether identifying DNA and RNA abnormalities in cancer tissue can help assign patients to specific treatments including valemetostat tosylate, carboplatin with cabazitaxel, or physician-chosen therapies such as cabazitaxel, abiraterone acetate with prednisone, enzalutamide, or lutetium Lu 177 vipivotide tetraxetan. The study aims to assess tumor response, safety, progression-free survival, overall survival, and patient-reported outcomes. Patients undergo genetic testing on previously collected tissue samples to determine their treatment group. In Arm A, patients receive valemetostat tosylate orally once daily in 28-day cycles. Arm B patients receive carboplatin and cabazitaxel intravenously every 21 days. Arm C patients receive one of several treatments chosen by their physician, including intravenous cabazitaxel every 21 days, oral abiraterone acetate with prednisone daily in 28-day cycles, oral enzalutamide daily in 28-day cycles, or lutetium Lu 177 vipivotide tetraxetan intravenously every 42 days for up to six cycles. Throughout treatment, patients have MRI, CT, and bone scans, with optional PET scans and blood collections. After treatment, patients without disease progression are followed every two months for six months, then every three months for up to five years those with progression are followed every six months for five years. Assessments include imaging, laboratory tests, and patient questionnaires to measure tumor response, progression, survival, symptomatic events, treatment tolerability, and quality of life. The trial monitors outcomes such as objective response within six months and longer-term survival up to five years.

Researchers are evaluating the addition of pembrolizumab immunotherapy to standard chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer NSCLC that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival among different treatment approaches, including chemotherapy alone, chemotherapy followed by pembrolizumab, and chemotherapy combined with pembrolizumab. The study also assesses quality of life and adverse event rates in these patient groups. Participants are randomly assigned to one of three groups. One group receives only chemotherapy with observation afterward. The other two groups receive chemotherapy followed by pembrolizumab or chemotherapy combined with pembrolizumab. Chemotherapy involves one of four platinum doublet regimens administered every 21 days for four cycles, depending on the physicians choice. Pembrolizumab is given intravenously over 25-40 minutes, either after chemotherapy or alongside it, repeated every 21 days or every 6 weeks for multiple cycles. Patients also undergo heart ultrasound, MRI, CT scans, and blood sample collections as part of the study. During the trial, participants have regular medical assessments including imaging and blood tests to monitor their health. 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 from randomization. Researchers measure disease-free survival as the main outcome, tracking the time until cancer recurrence or death. They also evaluate overall survival, side effects, drug tolerability, and patient-reported quality of life over time.