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Набира участници Фаза 2

Individualizing Approaches to Surveillance Mammography in Older Breast Cancer Survivors - The I-MAMMO Study

Breast Cancer

This study evaluates the effectiveness of a Shared Decision-Making (SDM) toolkit designed to support older breast cancer survivors aged 80 and above in making informed decisions about continuing surveillance mammography.

Начало: 11.09.2025 Край: 11.09.2029 Възраст: от 80 г.

United States Dana-Farber Cancer Institute NCT07123649

Набира участници

IMmune checkPoint Inhibitor Related gonAdal toxiCiTy in Premenopausal Women and Men With Melanoma

Melanoma (Skin Cancer)

This study aims to capture information regarding the effect of immune checkpoint inhibitor (ICI) treatment for melanoma on reproductive organ function and sex hormone levels. You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with melanoma (Stage II, III or IV) and you are planning to receive ICI treatment. Additional criteria will apply dependent upon your biological sex characteristics. All participants who choose to enroll in this study will be asked to complete a series of questionnaires and provide blood at 4 of their scheduled treatment visits. These visits are anticipated to add 30 minutes to the scheduled visit time. Male participants will also be asked to provide semen samples at 2 of their scheduled treatment visits. These visits are anticipated to add an additional 30 minutes to the scheduled visit time. No additional or novel treatments will be offered to participants who choose to enroll in this study, this is an observational study only. It is hoped this research will contribute important information regarding the potential toxic effects of ICI treatment on sexual and reproductive function in patients with melanoma who are receiving ICI treatment.

Начало: 11.09.2025 Край: 01.12.2027 Възраст: 18–60 г.

Australia Peter MacCallum Cancer Centre, Australia NCT07138222

Набира участници Фаза 2/3

A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)

Breast Neoplasms

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

Начало: 11.09.2025 Край: 15.05.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +22 Bristol-Myers Squibb NCT06926868

Набира участници Фаза 3

Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC

Esophageal Cancer Chemoradiotherapy

Definitive chemoradiotherapy (CRT) is the standard treatment for locally advanced unresectable esophageal cancer, but its efficacy remains unsatisfactory. More importantly, there is a lack of effective consolidation treatment after CRT, resulting in a high recurrence rate. Our previous prospective phase II trial (EC-CRT-001) demonstrated that the addition of toripalimab to definitive CRT improved the complete response rate in patients with locally advanced esophageal squamous cell carcinoma (ESCC), showing potential for enhanced long-term survival with a manageable safety profile. Nevertheless, the risk of recurrence requires further reduction. Metronomic capecitabine chemotherapy can modulate the tumor immune microenvironment and may synergize with PD-1 antibodies to enhance antitumor efficacy, potentially further prolonging survival in ESCC. Based on current research advances and our preliminary findings, this randomized, controlled, multicenter, phase III clinical trial aims to evaluate the efficacy and safety of toripalimab combined with capecitabine as maintenance therapy for patients with locally advanced ESCC who have not progressed after definitive CRT.

Начало: 10.09.2025 Край: 31.05.2030 Възраст: 18–75 г.

China Sun Yat-sen University NCT07177794

Набира участници

STATIC - Statin Termination in Cancer

Cancer

There are many guidelines on when to start drug treatment, but surprisingly few guidelines on how and when to stop drugs. For example, there are currently no clear guidelines on when to stop preventive medications such as statins in patients in palliative cancer care. According to previous studies, these drugs are often deprescribed far too late in the process, often close to death. This can lead to unwanted side effects, such as muscle weakness, increased fatigue, and also contribute to unnecessary drug costs and unnecessary environmental impact. In the STATIC I study the safety and effects of early deprescribing of statins in palliative cancer care is explored. The primary aim of the STATIC study is to study the change in LDL-levels (mmol/L) after statin termination. The secondary outcomes includes change in levels of other steroids (cholesterol, HDL, Q10, 25-hydroxyvitamin D, lanosterol), change in muscle strength, cardiovascular events, fatigue and quality of life after statin deprescribing. STATIC I is a pilot study to optimize the design for the randomized study STATIC II. The study aim at including 40 patients with advanced cancer within specialized palliative care with an expected survival time \>1 month to \

Начало: 10.09.2025 Край: 31.12.2027 Възраст: от 18 г.

Sweden Stiftelsen Stockholms Sjukhem NCT07543432

Набира участници Фаза 2

Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia

Myelodysplastic Syndromes Acute Myeloid Leukemia Myelodysplastic/Myeloproliferative Neoplasm

Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are serious, life changing blood cancers. Patients with MDS and AML commonly experience complications related to bleeding, which affect patient quality-of-life and can sometimes lead to hospitalization or death. The investigators will conduct a randomized controlled trial to evaluate the effectiveness and safety of tranexamic acid (TXA; a medication that prevents clots from dissolving) to prevent bleeding. In this study, 50% of patients will be randomized (like the flip of a coin) to receive TXA; the other 50% of patients will receive placebo. The investigators will monitor both groups of patients to see if the medication improves the risk and/or severity of bleeding. If tranexamic acid were to safely reduced the frequency of bleeding, this would broadly influence how doctors provide care for patients with MDS and AML around the world.

Начало: 10.09.2025 Край: 01.04.2027 Възраст: от 18 г.

Canada University of Manitoba NCT06599762

Набира участници Фаза 2

A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)

Carcinoma, Non-Small-Cell Lung

The purpose of this study is to evaluate the safety and efficacy of BMS-986504 monotherapy in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion after progression on prior therapies.

Начало: 09.09.2025 Край: 30.12.2031 Възраст: от 18 г. Лечение

Australia, China, France +9 Bristol-Myers Squibb NCT06855771

Набира участници

Fatigue and Mental Well-Being in MS Patients(Multiple Sclerosis)

Multiple Sclerosis

This study will be conducted to evaluate the effects of Quran recital on fatigue and mental well-being in patients with multiple sclerosis. Hypotheses: 1. Quran recital reduces fatigue in MS patients. 2. Quran recital increases mental well-being in MS patients. The patients will be called by the researcher to ask whether they continue this practice. The control group will continue their routine treatment and care and no additional intervention will be applied. The final test measurements will be made by meeting with the patients in the hospital at the end of the 4th week.

Начало: 09.09.2025 Край: 15.05.2026 Възраст: 18–80 г.

Turkey (Türkiye) Artvin Coruh University NCT07544303

Набира участници

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

Aortic Stenosis Treated With TAVI Aortic Diseases

The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)

Начало: 09.09.2025 Край: 01.01.2027 Възраст: от 50 г. Лечение

Australia, United States EnCompass Technologies, Inc. NCT06689839

Набира участници

Digital Telecytology for Triage of HPV-Positive Women in Cameroon

Human Papillomavirus Infection Cervical Intraepithelial Neoplasia Grade 2 (CIN2) Cervical Cancer Screening Methods

This study evaluates the diagnostic accuracy and feasibility of a same-day cervical cancer screening strategy using HPV self-sampling followed by digital telecytology triage among HPV-positive women in Cameroon. Women aged 30-49 years (or 25-49 years if HIV-positive) will undergo primary HPV testing using the GeneXpert system. HPV-positive women will be managed according to an extended HPV genotyping-based algorithm, including immediate treatment, telecytology triage, or follow-up. Histological assessment serves as the reference standard for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Secondary objectives include evaluation of AI-assisted telecytology and visual inspection with acetic acid (VIA), as well as the acceptability of screening and treatment strategies among women and healthcare providers. The study aims to generate evidence to support scalable, WHO-recommended test-triage-treat approaches in low-resource settings

Начало: 08.09.2025 Край: 08.09.2027 Възраст: 25–50 г.

Cameroon University Hospital, Geneva NCT07550010

Набира участници

Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Cancer: A Randomized Clinical Trial

Childhood Cancer Survivor Chronic Pain

The purpose of the study is to determine if an adapted mobile cognitive behavioral therapy (CBT) app (WebMAP Onc) is more effective than standard pain education in reducing chronic pain and improving daily functioning in adolescent survivors of pediatric cancer. This randomized study led by St. Jude Children's Research Hospital will involve 228 participants (114 adolescent survivors and 114 caregivers) across four U.S. hospitals. Outcomes include pain reduction, improved function, and the role of social determinants of health. Assessments occur at baseline, post-treatment, and 3-month follow-up.

Начало: 05.09.2025 Край: 01.02.2029 Възраст: 10–17 г.

United States St. Jude Children's Research Hospital NCT07160621

Набира участници Фаза 3

A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

Начало: 04.09.2025 Край: 17.04.2028 Възраст: от 18 г. Лечение

Australia, Austria, Belgium +18 BeOne Medicines NCT06973187

Набира участници Фаза 1

A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases

Refractory Autoimmune Diseases

The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory autoimmune diseases.

Начало: 04.09.2025 Край: 16.08.2030 Възраст: от 18 г. Лечение

Australia, Brazil, Czechia +7 Juno Therapeutics, Inc., a Bristol-Myers Squibb Company NCT07115745

Набира участници Фаза 4

Intraosseous vs. Intravenous Vancomycin Prophylaxis for Diabetic Foot Amputations: A Randomized Trial

Diabetic Foot Disease Diabetic Foot Infection Diabetic Amputation Foot Wound

he purpose of this study is to compare the effects of two different ways of giving the antibiotic vancomycin to prevent infections in patients undergoing amputation due to diabetic foot infection. Patients with diabetes often have poor blood circulation in their legs, which may prevent standard intravenous (IV) antibiotics from reaching the surgical site in high enough concentrations. This study compares: Intraosseous (IO) Administration: Giving the antibiotic directly into the bone at the amputation site during surgery. Intravenous (IV) Administration: Giving the antibiotic through a standard vein infusion before surgery. The researchers want to find out if the intraosseous method: Reduces the rate of surgical site infections compared to the standard IV method. Causes fewer changes in kidney function (measured by serum creatinine levels). Decreases the need for additional surgeries (reoperations) within 90 days. Patients will be randomly assigned to either the IO or IV group and will be followed for up to 90 days to evaluate their recovery and clinical outcomes

Начало: 03.09.2025 Край: 19.06.2026 Възраст: от 18 г.

Turkey (Türkiye) Başakşehir Çam & Sakura City Hospital NCT07338773

Набира участници

Clinical Outcomes After Non-curative Endoscopic Resection in Early Colorectal Cancer: A Multicenter Study

Early Colorectal Cancer Non-curative Endoscopic Resection

This multicenter study aims to evaluate clinical outcomes and optimize management strategies in patients with early colorectal cancer who undergo non-curative endoscopic resection. Patients with non-curative resection following endoscopic treatment will be enrolled across multiple centers and managed according to real-world clinical decisions, including additional surgery or surveillance. Baseline demographic, endoscopic, and pathological characteristics will be systematically collected. The primary objective is to compare recurrence and survival outcomes between different management strategies. Secondary objectives include identifying prognostic factors associated with recurrence and developing a risk stratification model to guide individualized treatment decisions. All participants will undergo standardized follow-up according to clinical guidelines. This study is expected to provide real-world evidence to refine risk assessment, reduce unnecessary surgery, and improve personalized management for patients with early colorectal cancer after non-curative endoscopic resection.

Начало: 03.09.2025 Край: 01.12.2028 Възраст: 18–75 г.

China Nanfang Hospital, Southern Medical University NCT07542171

Набира участници Фаза 2

Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)

Non-cystic Fibrosis Bronchiectasis

This study is a phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose range finding study designed to explore the efficacy, safety, and tolerability of 2 active treatment regimens of CSL787 (immunoglobulin G \[IgG\] inhalation solution) compared with placebo over a period of 6 to 12 months independent of the occurrence of pulmonary exacerbations. The primary aim of the study is to characterize the overall effect of CSL787 as well as the dose response of 2 active treatment regimens of inhaled CSL787 administered to participants with NCFB toward prolonging the TTF exacerbation.

Начало: 03.09.2025 Край: 28.03.2028 Възраст: 18–85 г. Лечение

Australia, Japan CSL Behring NCT07048262

Набира участници

Treatable Traits in Interstitial Lung Disease

Interstitial Lung Diseases (ILD)

The goal of this clinical trial is to learn if a personalised treatment model of care "treatable traits" can improve quality of life and disease progression in patients with interstitial lung disease. The main question it aims to answer is, will providing a treatable traits model of care improve health-related quality of life (HRQoL) (primary outcome), symptoms, anxiety, physical activity, and body composition (secondary outcomes). Researchers will compare the treatable traits model to standard of care. Participants in both arms will complete surveys, a Dual-Energy X-Ray Absorptiometry (DEXA) and whole-body composition scan, lung function and blood tests. Those in the intervention (TT) arm will be seen in a multidisciplinary clinic where they are seen by an ILD doctor, physiotherapist, psychologist, and dietitian.

Начало: 03.09.2025 Край: 01.07.2027 Възраст: от 18 г. Лечение

Australia The University of Western Australia NCT06626438

Набира участници Фаза 1

Phase 1 Single and Multiple Ascending Dose of LTG-321 in Healthy Participants

Healthy Participants

This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered LTG-321 in healthy male and female participants 18 to 55 years of age. The study will be conducted in New Zealand. The study also includes a randomized, double-blind, placebo-controlled, within-participant crossover evaluation of pain tolerance using a cold pressor test in healthy male participants 18 to 55 years of age. In addition, a randomized, open-label, crossover Food Effect cohort will evaluate the impact of a high-fat meal on the pharmacokinetics of LTG-321 following single oral doses in the fed and fasted state.

Начало: 03.09.2025 Край: 01.07.2026 Възраст: 18–55 г. Лечение

New Zealand Latigo Biotherapeutics NCT07110610

Набира участници Фаза 3

Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a)

Elevated Lp(a) Atherosclerotic Cardiovascular Disease (ASCVD)

The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.

Начало: 02.09.2025 Край: 01.03.2031 Възраст: от 18 г. Лечение

Argentina, Australia, Austria +24 Eli Lilly and Company NCT07157774

Набира участници Фаза 3

Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue

Brain Tumor, Pediatric Cancer-related Fatigue Methylphenidate

Cancer-related fatigue is a common and debilitating late effect in pediatric brain tumor survivors. Currently, evidence-based recommendations to ameliorate this condition are lacking. The researchers will investigate the ability of methylphenidate to improve fatigue and cognition in pediatric brain tumor survivors suffering from cancer-related fatigue. Methylphenidate is a drug (central nervous stimulant) most commonly used in the treatment of hyperkinetic disorders such as attention-deficit/hyperactivity disorder (ADHD). If methylphenidate shows an effect, the prospects are important for this patient group, since methylphenidate may then be included as part of the treatment of brain tumor-related fatigue.

Начало: 02.09.2025 Край: 01.12.2029 Възраст: 6–27 г.

Denmark Odense University Hospital NCT06905587

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