Huntingdon

Researchers are evaluating patients with early-stage estrogen receptor positive (ER+) and HER2 negative breast cancer who are receiving adjuvant endocrine therapy and have high-risk clinical features for relapse. The study aims to detect molecular relapse early using circulating tumor DNA (ctDNA) analysis and to compare whether adding palbociclib and fulvestrant can delay or prevent relapse compared to standard endocrine therapy. This is a phase 2, multi-center, randomized, open-label trial focusing on patients with no visible disease on imaging but positive ctDNA results indicating molecular relapse. The trial has two phases. The first is a surveillance phase where patients undergo ctDNA testing every three months for up to three years to monitor for molecular relapse. If ctDNA is detected without visible disease on imaging, patients enter the second, treatment phase where they are randomly assigned to receive either standard endocrine therapy or a combination of palbociclib (125 mg daily for 21 days in each 28-day cycle) and fulvestrant injections (500 mg intramuscularly on specified days). Treatment lasts up to 24 months, with imaging every six months to check for visible disease. Participants will have regular blood tests and imaging scans to monitor disease status and treatment effects. Researchers will measure the incidence of positive ctDNA results over up to 36 months and relapse-free survival over 60 months from randomization. Safety and treatment adherence will be closely tracked, and patients discontinuing due to visible disease will receive standard care outside the trial. The total follow-up includes the surveillance and treatment phases with ongoing monitoring.

Severe diabetic macular oedema (DMO) is a condition where fluid builds up in the macula, the central part of the retina responsible for detailed vision, leading to sight loss. This trial studies people over 18 years old with type 1 or type 2 diabetes who have severe DMO, defined by a thickened macula (400 microns or more). Researchers are comparing the current standard treatment of anti-VEGF eye injections alone to a new approach where patients start with anti-VEGF injections and switch to subthreshold micropulse laser (SML) treatment once the macula thickness decreases below 400 microns. Participants will be randomly assigned to receive either ongoing anti-VEGF injections or to switch to SML treatment after initial anti-VEGF therapy. Anti-VEGFs such as ranibizumab, aflibercept, faricimab, and brolucizumab are given as monthly injections at first, then every 1-3 months. The SML procedure, which does not damage the macula, will be applied based on the trial guidelines once the macula is less than 400 microns thick. This study aims to see if the combined treatment is as effective and more cost-efficient than anti-VEGF injections alone. Participants will attend regular clinic visits for eye exams including optical coherence tomography (OCT) scans to measure macula thickness and assessments of visual acuity over 104 weeks after randomization. Researchers will monitor best-corrected visual acuity, side effects, participant experience, and cost-effectiveness. The trial includes follow-up for two years with safety monitoring and evaluation of how this approach might be adopted in routine care. The study is conducted at multiple hospital eye services across the UK.

This research aims to assess whether adding MRI imaging to the standard CT imaging for patients with suspected or confirmed sigmoid colon adenocarcinoma influences treatment decisions. The study compares standard preoperative CT and multidisciplinary team discussions against adding MRI scans to see if MRI identifies more high-risk tumors, potentially changing treatment plans and prognosis information. Participants are randomly assigned to either the control group receiving standard care with CT imaging or the intervention group receiving an additional MRI scan before surgery. Both groups undergo multidisciplinary team reviews based on their imaging results. The intervention involves extra radiological and pathological assessments and reporting that might affect treatment choices following local protocols. Participants are followed up at 1 and 3 years after recruitment, including quality of life questionnaires. The study measures differences in cancer staging on CT versus MRI and how these differences impact treatment strategies. The total follow-up duration extends up to three years after the last participant is recruited, ensuring long-term observation of outcomes and treatment effects.

Researchers are investigating the safety and effectiveness of adding olaparib, a PARP enzyme inhibitor, to platinum-based chemotherapy given before surgery in patients with triple-negative breast cancer (TNBC) and/or those with germline BRCA (gBRCA) mutations. This randomized phase II/III trial aims to see if this combined treatment improves the rate of pathological complete response (pCR) at surgery while monitoring safety outcomes. The study plans to enroll at least 780 patients, including a minimum of 220 with gBRCA mutations. Participants will receive a minimum of 21 weeks of chemotherapy followed by surgery. The treatment includes oral olaparib tablets taken twice daily about 12 hours apart, alongside intravenous paclitaxel and carboplatin given in cycles every three weeks. During the trial, standard supportive care like granulocyte-colony stimulating factor and anthracyclines may also be administered. For those with residual disease after initial treatment, there is an option to join a sub-study involving additional chemotherapy drugs. Throughout the study, patients will undergo screenings including BRCA mutation testing and various tumor marker assessments. Safety will be closely monitored by the trial team and an independent committee. The main outcomes measured are treatment-related side effects, pCR rates after surgery, and long-term efficacy assessed over approximately 5.5 years, with follow-up planned for up to 10 years after surgery.

Researchers are evaluating the safety and performance of the Prevision hip stem in patients undergoing revision total hip arthroplasty or treatment for periprosthetic fracture of the hip. This observational post-market clinical follow-up study aims to demonstrate that the functional outcome of the Prevision hip stem after two years is not worse than that of the previous generation implant and comparable revision hip stems. Different implant variants will be descriptively compared to understand outcomes across patient subgroups. The study involves implanting the Prevision hip endoprosthetic stem, which comes in both cementless and cemented versions. The implant system includes modular components with a short proximal and longer distal part, or monobloc stems, all using similar instrumentation to simplify variant switching during surgery. Modular components connect via a specific conical connection secured with a torque wrench and tension nut, and may include locking screws for extra bone fixation. The hip stem pairs with either a cementless or cemented acetabular cup. Participants will be followed up for assessments including functional evaluations of the hip after surgery, with a primary focus on the functional outcome two years post-implantation. The study sites choose the stem variant according to their routine and indications, and patient follow-up visits will monitor the implant's performance and safety. Functional outcomes, including the Oxford Hip Score, will be collected to assess success over time.