Valdosta

Researchers are collecting real-world data on the use of commercially available Boston Scientific drug-eluting devices for treating lesions in the peripheral blood vessels. This study aims to include patient populations not previously well represented in peripheral vascular disease trials and to gather health economic information to support the safe use of these devices. Participants will be treated with any eligible Boston Scientific drug-eluting device, such as the Ranger Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter or the ELUVIA Drug-Eluting Vascular Stent System. These devices are used to treat lesions located in the peripheral vasculature. The study is global, prospective, open-label, non-randomized, and involves multiple centers. During the study, researchers will monitor major adverse events and lesion patency over 12 months. Participants will be followed to assess the safety and effectiveness of the devices in real-world settings. Health economic data will also be collected to better understand the broader impact of these treatments.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma in this phase III trial. The study compares the effects of lenalidomide and dexamethasone given with or without daratumumab. These drugs work in different ways to stop tumor growth, and the combination with daratumumab, an immunotherapy, may better interfere with tumor cell growth and spread. The trial aims to assess overall survival, progression-free survival, treatment safety, and quality of life among participants. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on specific days across up to 24 cycles, combined with daily oral lenalidomide for 21 days and oral dexamethasone on days 1, 8, 15, and 22 for 12 cycles. The other group receives only lenalidomide and dexamethasone on the same schedule for up to 24 cycles. Treatment continues every 28 days until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans, and patient questionnaires to monitor treatment effects and quality of life. Researchers track overall survival for up to 15 years, evaluate minimal residual disease, and monitor medication adherence and adverse events. Follow-up visits occur every 3, 6, or 12 months after treatment ends to continue monitoring health outcomes.

Researchers are studying cancer cachexia (CC), a syndrome involving weight, muscle, and fat loss in patients with advanced colorectal, lung, or pancreatic cancer that cannot be removed by surgery or is at stage IV. This study aims to identify different diagnostic subtypes of CC based on host characteristics such as symptoms, physical activity, blood biomarkers, and body composition. The goal is to better understand the varied causes of CC to improve diagnosis and develop more effective treatments tailored to individual patients. Participants will complete surveys and physical function tests that each take about 30 minutes. They will provide blood and archived tumor samples and wear a device called an actigraph for 7 days to monitor sleep and activity. Standard care scans like CT or PET/CT will be done during the study. Data will be collected at the start and again at 3 months, with continued review of medical records up to 1 year. These procedures help researchers study changes in CC characteristics over time and explore tumor factors linked to this condition. During the study, patients will undergo assessments of weight, muscle loss, symptoms, physical activity, and function. Researchers will analyze blood samples, tumor tissue, and medical images while reviewing health records. The main outcome is identifying distinct CC subtypes and their association with survival. Follow-ups occur at 3 months and 1 year to track changes and outcomes. The study involves no treatment but focuses on observation and data collection to support future CC diagnosis and therapy improvements.

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 evaluating a connected customized treatment platform called CONCURxP to help patients with metastatic breast cancer adhere to their CDK4/6 inhibitor medication schedules. The study compares CONCURxP, which combines a WiseBag medication monitoring device with personalized text message reminders and healthcare provider follow-ups, to enhanced usual care where patients only use the WiseBag and receive educational materials. This research aims to improve medication adherence, symptom management, quality of life, and communication between patients and providers over a 12-month period. Participants are randomly assigned to one of two groups: Arm A uses the WiseBag and receives educational materials every four weeks for 12 months, while Arm B uses the WiseBag along with personalized text message reminders and healthcare provider follow-ups as part of the CONCURxP program. Patients in Arm B may also complete an interview within six months after study completion. A separate group, Arm C, includes non-patient participants who complete an interview 15 to 39 months after the first patient enrollment. After the intervention period, patients may be monitored for an additional six months. During the study, participants' medication adherence is tracked electronically using the WiseBag at 12 months after starting medication. Researchers also assess self-reported adherence, symptom burden, quality of life, patient-provider communication, self-efficacy for symptom management, financial worry, healthcare use, and survival outcomes. Patient interviews and electronic health record reviews support the collection of these data. The study involves surveys, text messaging, medication tracking, and follow-ups to understand and improve adherence and overall patient experience.

This research aims to evaluate whether people with mild Alzheimer's disease can learn and retain skills to resist falls through a special training method. It focuses on how these individuals adapt to unexpected balance disturbances and whether they can apply these skills in different situations to reduce their risk of falling. Participants will be assigned to one of two groups: one will receive perturbation training involving repeated balance disturbances on a treadmill while secured by a harness, and the other will not receive this training. Both groups will then be exposed to balance challenges on the ground immediately after training and again at three and six months later. Researchers will track falls occurring during daily life over six months following the training. During the study, participants’ ability to resist falls will be tested in the lab and monitored in real life. Assessments include exposure to induced balance disturbances and tracking all falls over six months. The study will measure fall rates caused by laboratory challenges and daily living and compare the results between trained and untrained groups to see if the training leads to lasting and transferable fall resistance skills.

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.

Researchers are evaluating the effectiveness and safety of sacituzumab govitecan-hziy (SG) combined with pembrolizumab compared to the treatment chosen by a doctor, which may be pembrolizumab alone or pembrolizumab with capecitabine. This study focuses on patients with triple negative breast cancer who still have invasive cancer remaining after surgery and pre-surgical treatment. The study is a phase 3, randomized, open-label trial designed to assess outcomes in this patient group. Participants receive sacituzumab govitecan-hziy and pembrolizumab through intravenous infusion as the experimental treatment. The comparison group receives the physician's choice of treatment, which involves either pembrolizumab alone intravenously or pembrolizumab combined with oral capecitabine tablets. Both treatment options follow surgery and prior therapy, targeting residual invasive disease. Throughout the study, participants are monitored up to 60 months to measure invasive disease-free survival, which indicates the time without cancer recurrence or progression. Researchers will track treatment safety and effectiveness through regular assessments. The study involves tissue sample submissions from before and after neoadjuvant therapy and surgery, performance status evaluations, organ function tests, and recovery status from surgery and radiotherapy.