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Found 6 Actively Recruiting clinical trials

A

Actively Recruiting

Researchers are evaluating how well elritercept (TAK-226, KER-050) works in reducing the need for red blood cell (RBC) transfusions in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require regular blood transfusions. The study is a Phase 3, double-blind, randomized, placebo-controlled trial that also aims to assess the safety and tolerability of elritercept over both short and longer periods, including in adults with high transfusion needs. Participants will be randomly assigned in a 2:1 ratio to receive either elritercept or a matching placebo by subcutaneous injection every 4 weeks. The study includes a Primary Phase lasting 24 weeks and a Secondary Phase lasting an additional 24 weeks, during which participants continue the same treatment. Following these phases, an Extension Phase allows eligible participants to continue treatment until discontinuation or study unblinding. Study visits occur every 2 weeks during the first 6 cycles and every 4 weeks thereafter. Treatment continuation depends on meeting disease assessment criteria every 24 weeks. Participants will undergo various assessments including bone marrow aspirates, transfusion evaluations, and disease status checks throughout the study. Safety follow-up lasts for 8 weeks after the last dose, with visits every 4 weeks during this time. Afterward, long-term follow-up occurs quarterly for up to 5 years or until withdrawal, death, loss to follow-up, or study closure. The main outcome measured is the percentage of participants achieving transfusion independence for at least 8 weeks during the first 24 weeks of treatment.

Age: 18Years +All GendersPhase 3
179 locations
H

Actively Recruiting

Researchers are evaluating two surgical approaches for patients with low risk differentiated thyroid cancer in this multi-center, randomized, phase III study. The study aims to determine if hemithyroidectomy, which removes part of the thyroid, is an acceptable and cost-effective alternative to total thyroidectomy, which removes the entire thyroid. Patients are identified through oncology multidisciplinary team meetings and divided into two groups based on their treatment history and diagnosis method. Patients in Group 1 have already had a hemithyroidectomy for thyroid problems and are then diagnosed with low risk differentiated thyroid cancer. They will be randomized to either surveillance only or a second surgery to remove the rest of the thyroid gland (two-stage total thyroidectomy). Group 2 patients are diagnosed by cytology with low risk cancer and have not yet had surgery; they will be randomized to either hemithyroidectomy or a single-stage total thyroidectomy. The study plans to recruit 456 patients who will be followed after surgery and then every 12 months for 6 years. During the study, participants will undergo regular assessments to monitor for any signs or symptoms of cancer recurrence, with a primary outcome measure of the 3-year recurrence rate after surgery. Follow-up visits will include clinical evaluations to check for cancer return or progression. Researchers will also observe overall patient outcomes and safety throughout the 6-year follow-up period.

Age: 16Years +All GendersPhase Not Applicable
33 locations
I

Actively Recruiting

Researchers are evaluating whether regular MRI scans can better detect cancer progression in patients on active surveillance for low to medium risk prostate cancer compared to the current standard care recommended by NICE. This study focuses on patients who have chosen active surveillance, as immediate treatment may not improve survival but can cause significant side effects. The trial aims to improve detection of progression over 5 years with fewer biopsies, PSA tests, and clinic visits, potentially reducing anxiety and healthcare costs. Participants will be randomly assigned to either regular MRI scans or the current standard of care. Those in the MRI group will have PSA tests every 6 months and MRI scans annually if they have visible lesions or medium risk cancer. Other patients will have PSA every 6 months and MRI scans in years 1, 3, and 5. Targeted biopsies will be done if MRI shows signs of progression. The standard care group will follow NICE guidelines with regular PSA tests, rectal exams, and biopsies as indicated. During the study, patients will undergo diagnostic MRI scans and biopsies as needed, with monitoring including PSA testing and clinical examinations. The main outcomes measured are biopsy results and cancer staging over 5 years. The study is not blinded and stratifies patients by MRI lesion visibility, cancer grade, and time since diagnosis to ensure balanced groups. The total duration of follow-up is 5 years to assess progression detection and resource use.

Age: 18Years +MALEPhase Not Applicable
12 locations
R

Actively Recruiting

Researchers are investigating treatments for patients with localized renal cell carcinoma (RCC) who have undergone nephrectomy, focusing on those at high or intermediate risk of the cancer returning. The study evaluates whether durvalumab alone or combined with tremelimumab can improve disease-free survival or overall survival compared to the current standard of care, which is active monitoring. This phase III multi-arm, multi-stage randomized controlled trial includes patients with specific risk scores, and recruitment of intermediate risk patients will be limited based on time and accrual targets. Participants will be randomly assigned to receive either durvalumab alone, the combination of durvalumab and tremelimumab, or active monitoring. The drugs are given via controlled infusion through a pump into a vein. The trial includes a screening phase and treatment period, with careful monitoring of patients' disease status and side effects throughout the study. During the study, participants will undergo clinical and radiological assessments, including post-operative scans and laboratory tests like blood counts and ECGs. Researchers will track disease-free survival and overall survival over several years, including specific time points up to 20.5 years for some comparisons. Participants will also provide tissue and blood samples for future research. Safety and treatment effects will be closely monitored to understand how the therapies impact long-term outcomes.

Age: 18Years +All GendersPhase 3
35 locations
R

Actively Recruiting

Researchers are evaluating a new treatment for patients with triple-negative breast cancer that is locally recurrent, inoperable, or metastatic, who are not eligible for PD(L)1 immunotherapy based on their PD-L1 status. This Phase III trial compares the investigational drug pumitamig combined with chemotherapy to a placebo combined with chemotherapy. The study aims to measure how long participants live without their disease worsening and overall survival, with monitoring periods up to approximately 32 and 49 months respectively. Participants will be randomly assigned to one of two groups: one receiving pumitamig plus chemotherapy chosen by their physician, and the other receiving a matching placebo plus chemotherapy. Chemotherapy options include paclitaxel or nab-paclitaxel, gemcitabine plus carboplatin, or eribulin, all given as intravenous infusions. The treatment period continues until disease progression, unacceptable side effects, withdrawal, death, or trial end. The study includes a screening phase of up to 28 days, a treatment phase, a safety follow-up up to 90 days after the last dose, and a long-term survival follow-up. During the trial, participants will undergo assessments including tumor measurements based on RECIST criteria and tissue sample collection before starting treatment. The trial is double-blinded, so neither participants nor doctors know which treatment is given. Safety and efficacy are carefully monitored through regular evaluations. Participants remain in the study for as long as they continue treatment and follow-up, which may last several years depending on survival and consent.

Age: 18Years +All GendersPhase 3
83 locations
U

Actively Recruiting

Heart failure occurs when the heart cannot pump blood properly, causing symptoms like breathlessness, swelling, and tiredness. About half of heart failure patients have a normal ejection fraction, known as heart failure with preserved ejection fraction (HFpEF). HFpEF is complex and varies between patients, with unclear causes, severity factors, and limited treatment options. This research aims to better understand HFpEF by studying many patients over time to discover why it develops, improve diagnosis, and find new treatments. The study will create a UK-wide registry collecting detailed information from patients diagnosed with HFpEF by heart failure experts. This registry will include clinical data and outcomes from many centers, enabling advanced analysis to identify different HFpEF subgroups. The platform will support the development of personalized diagnostics and targeted treatment trials, improving how HFpEF is managed. It also facilitates collaboration with industry and enhances patient recruitment for future studies. Participants will provide consent and be diagnosed with HFpEF confirmed by a specialist. Their health data will be collected and linked to long-term outcomes, including measurement of natriuretic peptides. Researchers will monitor and analyze patient information over many years to identify distinct HFpEF groups, understand causes, and improve risk prediction. The study excludes patients with certain heart conditions or very reduced heart function. This long-term approach aims to improve personalized care for people living with HFpEF.

Age: 18Years +All Genders
26 locations
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