Fishersville

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

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 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 evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are investigating neoadjuvant darovasertib in adults with primary non-metastatic uveal melanoma in a Phase 3, randomized, open-label, multi-center trial. The study aims to compare treatment outcomes between darovasertib combined with local therapies and standard immediate local therapies. Two patient groups are studied: one requiring plaque brachytherapy and another requiring either plaque brachytherapy, proton beam radiation, or enucleation. In the first group, participants in the treatment arm receive oral darovasertib twice daily in 28-day cycles before plaque brachytherapy, while the control group undergoes immediate plaque brachytherapy. In the second group, the treatment arm receives darovasertib followed by definitive local therapy, whereas the control arm proceeds directly to enucleation. All patients then receive their assigned primary local therapy. Participants will be followed for up to three years to monitor longer-term outcomes including vision loss, tumor recurrence, and eye preservation. The main outcomes measured are the proportion of subjects with vision loss in the first group and the ability to save the eye and avoid enucleation in the second group. Safety and effectiveness of treatments will be assessed throughout the study period.

Researchers are investigating whether observation is as effective as continuing pembrolizumab treatment in patients with early-stage triple-negative breast cancer who achieved a complete response after preoperative chemotherapy combined with pembrolizumab. This phase III trial aims to evaluate recurrence-free survival and quality of life, as well as the value of reducing immunotherapy treatment after surgery in these patients. The study also examines differences in adverse events, overall survival, and financial impacts between treatment approaches. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group receives pembrolizumab intravenously as adjuvant therapy, while the other group undergoes observation without further treatment. Both groups have tumor biopsies and blood samples collected on study and during follow-up. Additional assessments include questionnaires and quality-of-life evaluations. During the study, researchers monitor participants for up to 10 years to measure recurrence-free survival. They assess quality of life using validated tools, track adverse events, and evaluate financial toxicity and work productivity. The study includes tumor tissue analysis, blood sample collection, and patient-reported outcomes to understand the long-term effects and value of treatment de-escalation in breast cancer care.

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 studying patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based treatments to understand the risk of heart problems related to their cancer therapy. The study includes two groups: one large observational group of patients already taking beta blockers, ACE inhibitors, or ARBs alongside their cancer treatment, and a smaller randomized group comparing patients who receive carvedilol, a heart medication, to those who do not. The trial aims to assess how often heart issues occur and whether carvedilol can help prevent heart damage from chemotherapy. It also investigates biomarkers and heart function measures as predictors of cardiac risk. In the randomized part, patients not already on beta blockers, ACE inhibitors, or ARBs are assigned to receive carvedilol twice daily or no additional treatment for up to 108 weeks, with treatment cycles repeated every 12 weeks if there is no disease progression or unacceptable side effects. Patients already taking these heart medications join the observational cohort and are monitored for up to 108 weeks without any change in their therapy. The study collects blood samples and performs regular heart imaging to evaluate heart function and strain. Participants will have regular echocardiograms every 12 weeks to monitor heart function, with both local and central readings compared. Blood samples are collected for biomarker analysis, and patient health status is assessed throughout the study. The main outcome measured is the time until any heart dysfunction is first detected, followed for up to 108 weeks. The study also tracks interruptions in cancer therapy due to heart problems and explores genetic and plasma markers that might predict heart risk. Participants are followed closely for safety and treatment effects during the entire study period.

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.