Manchester

Researchers are studying the safety and effectiveness of intravitreal KSI-101 injections in adults with macular edema caused by inflammation, called Macular Edema Secondary to Inflammation MESI. This Phase 3 clinical trial aims to evaluate how well KSI-101 works compared to a sham injection in improving vision for people with this condition. Participants will receive one of three treatments KSI-101 at 5 mg or 10 mg doses injected into the eye every 4 weeks for six months, followed by dosing tailored to individual needs, or a sham injection following the same schedule. The study is randomized, double-masked, and controlled to ensure unbiased results. During the trial, participants will undergo vision tests to measure changes in best-corrected visual acuity BCVA over 24 weeks. Researchers will monitor safety and treatment effects throughout the study. The trial is expected to run until November 2027, with participants receiving regular assessments and follow-ups to track their eye health and response to treatment.

Researchers are conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of intravitreal KSI-101 in adults with macular edema caused by inflammation, known as Macular Edema Secondary to Inflammation MESI. The study aims to understand how well this treatment works compared to a sham injection in improving vision and reducing eye swelling related to this condition. Participants are randomly assigned to receive one of three treatments an intravitreal injection of KSI-101 at either 5 mg or 10 mg doses once every four weeks for six months, followed by personalized dosing schedules, or a sham injection on the same schedule. The injections are given directly into the eye, and the study is double-masked to ensure unbiased results. During the study, participants will undergo regular eye exams to measure visual acuity and eye thickness using specialized imaging. The main outcome is the change in best corrected visual acuity at 24 weeks. Researchers will also monitor the proportion of participants who show improvement in vision over this period. The trial includes safety assessments and will continue until August 2027, with detailed monitoring throughout the treatment and follow-up phases.

Researchers are evaluating survival outcomes for patients with early stage cervical cancer undergoing either robotic-assisted laparoscopy or open hysterectomy with lymph node assessment. This multi-center, randomized trial tests the hypothesis that robotic hysterectomy with tumor containment before colpotomy is not inferior to abdominal hysterectomy regarding disease-free survival. The study focuses on patients with specific cervical cancer stages and tumor sizes, aiming to compare surgical approaches. Participants are randomly assigned to one of two groups the standard open surgery group performing radical or simple hysterectomy using established techniques with vaginal closure over the tumor before colpotomy, and the robotic surgery group using minimally invasive robotic-assisted hysterectomy with vaginal closure prior to intracorporeal colpotomy. Surgeons perform thorough intraoperative assessments for metastatic disease, and certain patients with confirmed metastases are excluded from final analysis. Detailed surgical data and complications are recorded for all cases. During the study, participants will undergo preoperative assessments, surgery, and follow-up evaluations. Researchers will monitor survival over 36 months as the primary outcome, documenting operative time, findings, blood loss, and complications. Patients will be followed to assess disease-free survival, with attention to surgical outcomes and safety. The total duration of participation includes the surgery and long-term survival monitoring to compare the effectiveness of the two surgical methods.

Researchers are evaluating whether adding adjuvant chemotherapy ACT to ovarian function suppression OFS plus endocrine therapy ET improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigators discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients health and quality of life.

Researchers are evaluating two approaches for managing neovascular age-related macular degeneration nAMD to find out if home optical coherence tomography OCT-guided treatment improves visual outcomes or reduces the number of injections compared to the common Treat and Extend dosing method. The study addresses the current challenge of determining the optimal number of anti-vascular endothelial growth factor anti-VEGF injections needed for each patient, aiming to reduce treatment burden and costs by allowing more personalized care through daily monitoring with home OCT. Participants will receive intravitreal injections of 6 mg faricimab and be randomly assigned to either the Treat and Extend group or the Home OCT-guided treatment group. The Treat and Extend group will have office visits every 4 to 18 weeks for vision testing and imaging, while the Home OCT group will perform daily self-scans at home and only return for visits when disease activity is detected by the home device. The study includes a baseline phase with initial injection and imaging confirmation before randomization, followed by 104 weeks of treatment and monitoring. During the study, participants will undergo vision tests, eye exams, and various imaging procedures at scheduled visits or as triggered by home OCT scans. Researchers will track changes in visual acuity and count the number of injections over two years. Close monitoring ensures scan quality and disease status before randomization. The study measures include the change in visual acuity letter score and total injections received, aiming to compare the effectiveness and treatment burden between the two methods over 104 weeks.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

Researchers are evaluating durvalumab, an immunotherapy drug, compared to standard patient observation after surgery in patients with early-stage non-small cell lung cancer who have no remaining cancer cells. The trial aims to determine if durvalumab can improve disease-free survival and overall outcomes compared to the usual approach of monitoring without additional treatment. This is a phase III randomized trial focusing on patients with stage II-IIIB non-small cell lung cancer who achieved a complete response after neoadjuvant chemo-immunotherapy. Participants are randomly assigned to one of two groups. One group receives durvalumab intravenously every 28 days for up to 12 cycles, pending no disease progression or unacceptable side effects. The other group undergoes active surveillance through regular follow-up without additional treatment for 12 months. Both groups have scheduled computed tomography scans and blood sample collections throughout the trial. Patients are followed annually for up to 10 years after treatment completion. During the study, participants undergo various assessments including CT scans, blood tests, and patient-reported quality of life questionnaires. Researchers monitor disease recurrence, new lung cancers, survival, and treatment side effects over a 10-year period. Quality of life and symptom evaluations related to skin and nerve sensations are also compared between the groups. This extensive follow-up helps evaluate the long-term effects and safety of durvalumab versus observation.

Researchers are creating and maintaining the Integrated Cancer Repository for Cancer Research iCaRe2, a multi-institutional resource gathering detailed, ongoing data and biospecimens from adult cancer patients, people at high risk, and healthy controls. This platform covers a wide geographic area, including many small and rural hospitals, to support comprehensive studies on cancer risks, development, progression, and to aid in designing new prevention, screening, early detection, and personalized treatment strategies. The iCaRe2 collects multi-dimensional cancer-related data and biospecimens such as tumor specimens, DNA, serum, urine, and plasma from various cancer registries covering numerous cancer types, including pancreatic, breast, thyroid, lung, gastrointestinal, genitourinary, central nervous system, blood cancers, skin cancers, and more. It uses a flexible confederation model allowing multiple centers to participate based on their expertise and resources. The platform is web-based, HIPAA compliant, and supports secure data collection, validation, standard vocabularies, and reporting. Participants provide informed consent and may include those diagnosed with cancer, at risk for cancer, or healthy controls. Data collection includes longitudinal monitoring and banking of biological materials for future study. Researchers measure the development and implementation of this web-based cancer registry and the procurement of biological materials over many years. Participants involvement includes data sharing and biospecimen donation, supporting studies in cancer biology, genetics, epidemiology, early detection, and patient care, with ongoing follow-up up to many years.

Researchers are evaluating the effects of two eye treatments, intravitreal faricimab injections and fluocinolone acetonide intravitreal implants, compared to observation alone, on long-term vision after treating choroidal melanoma with iodine-125 plaque brachytherapy. This trial aims to compare how well these treatments maintain visual acuity and prevent vision loss caused by radiation retinopathy. The study also seeks to understand the natural progression of radiation retinopathy using detailed imaging methods. Participants are divided into three groups one receiving 6.0 mg faricimab injections every three months, another receiving a 0.19 mg fluocinolone acetonide implant at the start and again at 24 months, and a third group observed without treatment unless macular edema develops. The fluocinolone implant is delivered with a specialized applicator, while faricimab is given via intravitreal injection. Treatment and observation continue with monitoring over time. During the study, participants will have their visual acuity measured at baseline and followed for three years to assess changes and the occurrence of significant vision loss. Researchers will use multimodal imaging techniques such as widefield color photos, fluorescein angiography, and OCT angiography to evaluate eye health and monitor radiation retinopathy progression. Safety and vision outcomes will be closely observed throughout the trial period, which lasts several years.

Researchers are evaluating the effects of two chemotherapy combinations, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for treating advanced, unresectable, or metastatic HER2 negative cancers of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine if overall survival improves with mFOLFIRINOX compared to mFOLFOX and to assess differences in progression-free survival, response rates, safety, and patient-reported outcomes. Participants are randomly assigned to one of two groups one receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan intravenously, with nivolumab given as needed the other group receives fluorouracil, leucovorin calcium, and oxaliplatin intravenously, also with nivolumab as indicated. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional research on markers like PD-L1 combined positive score and cell-free DNA. During the study, participants will have regular imaging scans and blood collections to monitor their cancer and treatment effects. Researchers will track overall survival for up to two years and monitor progression-free survival, tumor response, duration of response, and adverse events for up to three years. Patient-reported outcomes will be collected at baseline and throughout treatment cycles to assess tolerability and side effects.