Manchester

Researchers are conducting a multi-center, open-label, randomized clinical trial to compare survival outcomes between robotic-assisted laparoscopy and open surgery for patients with early stage cervical cancer. The study tests whether robotically assisted hysterectomy with tumor containment before colpotomy is not worse than abdominal hysterectomy regarding disease-free survival. Patients must have specific cancer types and stages without evidence of metastases to participate. Participants will be randomly assigned to either the robotic surgery group or the open surgery group. In the robotic arm, hysterectomy is performed using a minimally invasive robotic device with specific surgical protocols to close the vagina prior to colpotomy. In the standard arm, an open radical or simple hysterectomy is performed with vaginal closure over the tumor before colpotomy. Both groups may have ovary removal or preservation, and detailed surgical records are maintained. During the study, patients undergo preoperative assessments including imaging and lab tests, and pregnancy tests for pre-menopausal women. Surgeons document operative details and complications. The primary outcome is survival measured over 36 months. Follow-up includes monitoring for disease-free survival and safety. Participants must be able to attend follow-up visits and provide consent to share health information.

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 two treatment strategies for neovascular age-related macular degeneration (nAMD), a condition that affects vision in people aged 50 and older. This Phase 3 trial compares a standard "Treat and Extend" (T&E) dosing schedule of anti-vascular endothelial growth factor therapy with a newer approach guided by home optical coherence tomography (OCT) imaging. The study aims to find out if daily home OCT monitoring can improve visual acuity outcomes and reduce the number of injections needed over a period of 104 weeks compared to the standard T&E approach. Participants receive intravitreal injections of 6 mg faricimab, either on a Treat and Extend schedule or guided by daily home OCT scans. At baseline, participants undergo vision tests, ocular exams, and imaging, followed by a faricimab injection. Those eligible for randomization are assigned to one of the two treatment groups. The T&E group returns for office visits every 4 to 18 weeks, while the home OCT group performs daily self-scans and only visits the clinic if fluid above a certain threshold is detected. The study follows participants for 104 weeks, with key visits at 52 and 104 weeks. Participants are involved in daily home OCT scanning if assigned to that group, attend scheduled visits for vision and imaging assessments, and undergo monitoring for treatment response and safety. Researchers measure changes in visual acuity using the E-ETDRS letter score and count the number of faricimab injections over the two-year period. The study also assesses adherence to daily scanning and evaluates treatment burden and outcomes for each approach to managing nAMD.

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 durvalumab, an immunotherapy drug, compared to the usual approach of patient observation after surgery in people with early-stage non-small cell lung cancer (NSCLC) who have no remaining cancer cells following standard treatment. This phase III trial aims to determine if durvalumab can improve disease-free survival and overall survival, as well as assess its safety and impact on quality of life. The study focuses on participants with stage II to IIIB NSCLC who achieved a complete response after neoadjuvant chemo-immunotherapy and surgery. Participants are randomly assigned to one of two groups: one group receives durvalumab intravenously every 28 days for up to 12 cycles if there is no disease progression or unacceptable side effects, while the other group undergoes active surveillance without additional treatment for 12 months. Both groups have regular computed tomography (CT) scans and blood sample collections during the study. After treatment or surveillance, participants are followed annually for up to 10 years. Throughout the study, participants complete questionnaires about their quality of life and report symptoms such as rash or numbness. Researchers monitor disease recurrence, new lung cancers, or death, as well as treatment side effects. Specimens and images are collected for future research. The total participation time includes treatment or observation plus long-term follow-up visits to assess the effects and safety of durvalumab compared to observation alone.

Researchers are evaluating the Integrated Cancer Repository for Cancer Research (iCaRe2), a comprehensive multi-institutional resource developed by the Fred & Pamela Buffett Cancer Center. This resource collects and manages standardized, multi-dimensional, and longitudinal data and biospecimens from adult cancer patients, those at high risk, and normal controls. iCaRe2 includes data from a wide geographic area covering many small and rural hospitals and cancer centers, supporting studies on cancer risk factors, development, progression, and strategies for prevention, screening, early detection, and personalized treatment. iCaRe2 is a web-based, secure, HIPAA-compliant registry that integrates multiple specialized cancer collaborative registries covering a broad range of cancers such as pancreatic, breast, thyroid, thoracic, genitourinary, gastrointestinal, central nervous system, leukemia, gynecological, sarcoma, melanoma, and more. The system allows participating centers to contribute data and biospecimens like tumor samples, germ line DNA, serum, urine, and plasma. This flexible "confederation model" enables centers with different expertise and resources to collaborate on diverse research projects through a common platform. Participants include adult individuals aged 19 and older who have a cancer diagnosis or history, are at risk for cancer, have suspicious clinical findings, or have no history of cancer (normal controls). Data collection includes demographic, clinical, and biospecimen information. The registry supports multi-dimensional data mining and sharing to advance cancer research. The primary outcome is the ongoing development and implementation of this web-based cancer collaborative registry, with long-term data collection and collaboration planned over many years.

Researchers are evaluating the effect of intravitreal faricimab injections or fluocinolone acetonide (0.19 mg) intravitreal implants compared with observation on long-term visual acuity in patients treated for choroidal melanoma with iodine-125 plaque brachytherapy. This phase 3 randomized controlled trial aims to compare the long-term vision outcomes among eyes receiving repeated treatments versus those initially observed and treated only if macular edema develops. The study also seeks to understand if these treatments can prevent or change the course of macular edema caused by radiation retinopathy and to document the natural progression of radiation retinopathy using multimodal imaging techniques.

Researchers are evaluating two chemotherapy treatments, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for advanced, unresectable, or metastatic HER2 negative adenocarcinoma of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine whether adding irinotecan to the usual FOLFOX regimen improves overall survival and other outcomes such as progression-free survival, response rates, and treatment tolerability. The study also explores biomarkers like PD-L1 combined positive score and cell free DNA to understand treatment effects better. Participants are randomly assigned to one of two treatment groups. One group receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with nivolumab as needed, while the other group receives fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with nivolumab as needed. All drugs are given intravenously. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional testing. During the study, participants are closely monitored for overall survival for up to two years after randomization. Researchers assess safety, side effects, and patient-reported outcomes to evaluate treatment tolerability. The trial also tracks progression of disease and response to therapy using imaging and other clinical evaluations. Participation includes regular imaging, blood collection, and completing questionnaires to help understand the impact of these treatments.

This research aims to evaluate the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent stimulation device and therapy in patients with intermediate to advanced nonexudative age-related macular degeneration (AMD). The trial focuses on patients with this eye condition to better understand how this device may affect their vision and disease progression over time. Participants will first undergo an initial loading treatment regimen with the i-Lumen AMD device, followed by seven maintenance treatments spread across 11 months. The device delivers microcurrent stimulation through the eyelid (transpalpebral). After completing the treatment phase, participants will return monthly for evaluations up to month 14, which is three months after the last treatment, to monitor safety and effectiveness. Throughout the study, participants will attend monthly visits for assessments including measuring changes in best corrected visual acuity (BCVA) from baseline to month 3 and beyond. Researchers will also monitor safety continuously. The total participation time covers the entire treatment and follow-up periods, allowing detailed observation of vision changes and device effects over more than a year.

Researchers are evaluating ABBV-RGX-314, a novel one-time gene therapy, for treating neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD causes vision loss due to abnormal blood vessel growth in the retina and affects millions in the United States, Europe, and Japan. Current treatments require frequent eye injections, which can be burdensome and may lead to reduced vision over time. This Phase 3 study aims to compare the effectiveness and safety of two doses of ABBV-RGX-314 against the standard anti-VEGF drug, aflibercept, in people with wet AMD. Participants will be randomly assigned to receive one of two doses of ABBV-RGX-314 gene therapy or aflibercept injections. The gene therapy involves a one-time subretinal injection delivering a gene that produces an anti-VEGF protein to help control abnormal blood vessels. In addition, a bilateral treatment substudy will examine safety and effectiveness when both eyes are treated in participants with wet AMD in both eyes. This substudy will enroll up to 15 participants for at least 50 weeks of follow-up. During the study, participants will have their vision measured regularly to assess changes in best-corrected visual acuity (BCVA). Safety will be monitored by recording any eye-related adverse events and serious side effects. Participants will be followed for up to 54 weeks or more to evaluate how well the gene therapy maintains or improves vision compared to aflibercept and to assess overall treatment safety and tolerability.