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Набира участници Фаза 2

NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer

Adenocarcinoma of the Colon

Colorectal cancer (CRC) is the 2nd to 3rd most common malignant disease in developed countries, with over 1 million new cases and 500,000 deaths worldwide each year. The primary treatment for early stage CRC is surgery to remove the tumour, which is possible in 80% of patients. Even after surgery up to half of patients will develop recurrence or spread of the disease (metastases) which is incurable. Survival after 5 years is approximately 14% for patients with metastatic disease. Clinical trials using immunotherapy drugs called 'immune checkpoint inhibitors' have shown excellent results in advanced colorectal cancer patients who have certain genetic characteristics called 'mismatch repair deficiency (MMR-d)' and 'high microsatellite instability (MSI-h)'. The benefits of immunotherapy as a treatment prior to surgery to remove the tumour (neoadjuvant treatment) has been observed in both melanoma and in glioblastoma with enhanced local and systemic anti-tumour responses. Pembrolizumab is an immunotherapy drug and works by helping the body's own immune system to fight the cancer cells. The NEOPRISM-CRC trial will investigate whether giving pembrolizumab before surgery is safe, whether it improves the chances of the tumour being removed completely and whether it delays or prevents the cancer from coming back. Pembrolizumab treatment lasts for a maximum of 9 weeks (maximum of 3 cycles of treatment, each cycle consisting of 3 weeks) and is given prior to surgery. Following surgery patients will be followed up for at least 3 years after their surgery and to a maximum of 5 years. Target recruitment is 88 patients and recruitment is expected to take place over a 48 month period. Blood, tissue, mouth swabs and stool samples will be collected from patients throughout the trial to better understand the biology of immunotherapy as a treatment for CRC prior to surgery.

Начало: 20.07.2022 Край: 31.07.2029 Възраст: от 18 г.

United Kingdom University College, London NCT05197322

Набира участници

Baseline ACL Injury Risk Screening and Normative Data

ACL Injury Anterior Cruciate Ligament Injuries Musculoskeletal Injury

This is a prospective, observational cohort study aimed at establishing a database of normative biomechanics for healthy athletes and surveying these athletes for 12 months following baseline testing for the occurrence of new musculoskeletal injuries, with a particular emphasis on ACL injuries.

Начало: 19.07.2022 Край: 01.07.2033 Възраст: 10–65 г.

United States Sanford Health NCT06635668

Набира участници

Otoferlin Gene-mediated Hearing Loss Natural History Study

Sensorineural Hearing Loss, Bilateral

This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.

Начало: 14.07.2022 Край: 01.02.2029 Възраст: до 44 г.

Australia, Germany, Spain +4 Akouos, Inc. NCT05572073

Набира участници Фаза 1/2

A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas

LGLL - Large Granular Lymphocytic Leukemia Primary Cutaneous Gamma-Delta T-Cell Lymphoma Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma Hepatosplenic T-cell Lymphoma +9

This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas

Начало: 13.07.2022 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, France, Germany +6 Dren Bio NCT05475925

Набира участници

Collection of Blood Samples for New Diagnostic Devices 2

Embolism and Thrombosis Cardiovascular Renal Inflammation +1

To research and develop new state of the art diagnostic biomarkers on the LumiraDx Platform that are comparable to the approved gold standard reference methods and will radically enhance clinicians and patients ability to monitor health conditions and improve outcomes by delivering the results near patient at the point of care.

Начало: 11.07.2022 Край: 20.08.2026 Възраст: от 18 г.

United Kingdom LumiraDx UK Limited NCT05568966

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Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)

Erectile Dysfunction

This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction. This study follows patients implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for up to 3 years after implantation. This study will take approximately 6 months to enroll all subjects. (14 days, 6 weeks, 6 months, 12 months,18 months, 24 months, and 36 months, post-procedure. ) Subjects will be followed per protocol and institutional standard of care for ED and comorbidities.

Начало: 11.07.2022 Край: 21.05.2026 Възраст: от 22 г. Лечение

Australia Rigicon, Inc. NCT05574868

Набира участници Фаза 2/3

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

Stage III Colon Cancer

This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Начало: 08.07.2022 Край: 10.03.2030 Възраст: от 18 г.

Canada, Puerto Rico, United States NRG Oncology NCT05174169

Набира участници

The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD

Crohn Disease

The purpose of this study is to evaluate the safety of vagal nerve neuromodulation in a cohort of patients operated on for Crohn's disease, in a prospective, single centre, cohort study.

Начало: 08.07.2022 Край: 01.07.2028 Възраст: 18–80 г. Превенция

Australia Austin Health NCT05469607

Набира участници

INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)

Kidney Failure

The INCH-HD trial will test if incremental HD preserves the quality of life of patients and families and is a safe, practical, cost effective treatment option.

Начало: 06.07.2022 Край: 01.08.2026 Възраст: от 18 г. Лечение

Australia, Canada The University of Queensland NCT04932148

Набира участници Фаза 1

A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.

Melanoma Non-Small-Cell Lung Cancer Thyroid Cancer Glioma +1

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines in people with solid tumors. This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called "BRAF" and available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine: * People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day. * People with colorectal cancer may also receive cetuximab or cetuximab and mFOLFOX6 (Chemotherapy regimen). Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV). Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Начало: 05.07.2022 Край: 06.08.2030 Възраст: от 16 г.

Canada, Israel, United States Pfizer NCT05355701

Набира участници Фаза 4

The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials

Solid Tumors

The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib. All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib. Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years.

Начало: 05.07.2022 Край: 31.07.2029 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +14 Pfizer NCT05203172

Набира участници

Muscle Blood Flow Regulation in HFpEF

HFpEF

Heart failure with preserved ejection (HFpEF) disproportionately affects Veterans and is the number one reason for hospital discharge in the VA Health Care System. Exercise intolerance is a common complication experienced by patients with HFpEF, perpetuating physical inactivity and accelerating disease progression. This research proposal aims to elucidate mechanisms responsible for inadequate skeletal muscle blood flow and exercise intolerance in patients with HFpEF compared with healthy controls as well as following 8 weeks of exercise training in patients with HFpEF only.

Начало: 01.07.2022 Край: 29.02.2028 Възраст: от 18 г.

United States VA Office of Research and Development NCT05115890

Набира участници Фаза 3

Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour

Medulloblastoma, Childhood Cognitive Impairment

The efficacy of treatment with metformin for promoting cognitive recovery and brain growth in children/adolescents treated for a brain tumour will be investigated in a multi-site Phase III randomized double-blind placebo-controlled parallel arm superiority trial. Specifically, in children/adolescents aged 7 years to 21 years and 11 months who have completed treatment for a brain tumour, is oral administration of metformin for 16 weeks associated with greater improvement of cognitive function and brain growth compared to placebo administered for 16 weeks?

Начало: 01.07.2022 Край: 30.11.2027 Възраст: 7–21 г. Поддържаща грижа

Australia, Canada Donald Mabbott NCT05230758

Набира участници Фаза 3

A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C

Niemann-Pick Disease, Type C

A pivotal, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 4 and older with a confirmed diagnosis of Niemann Pick disease type C (NPC). The objective of this study is to evaluate the safety, tolerability and efficacy of N-acetyl-L-leucine (IB1001) compared to standard of care. Following this randomized, double-blind, placebo-controlled "Parent Study", an extension phase is conducted for (1) patients who completed the "Parent Study" and (2) patients who are enrolled directly into the Extension Phase. Currently, the Extension Phase provides patients with 3 years of open-label treatment.

Начало: 30.06.2022 Край: 01.12.2030 Възраст: от 4 г. Лечение

Australia, Czechia, Germany +5 IntraBio Inc NCT05163288

Набира участници Фаза 2/3

Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung

Advanced Extrapulmonary Neuroendocrine Carcinoma Metastatic Extrapulmonary Neuroendocrine Carcinoma Recurrent Extrapulmonary Neuroendocrine Carcinoma Unresectable Extrapulmonary Neuroendocrine Carcinoma

This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone.

Начало: 28.06.2022 Край: 01.10.2028 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT05058651

Набира участници Фаза 2

Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma

Cutaneous Squamous Cell Carcinoma of the Head and Neck Head and Neck Cancer

Cutaneous Squamous Cell Carcinoma (cSCC) is typically associated with a high tumour mutation burden, with the majority caused by Ultraviolet (UV) exposure (Pickering et al., 2014). The use of this trial using neoadjuvant Pembrolizumab in patients with cSCC who will otherwise undergo highly morbid radical surgical resection has multiple potential advantages, including: 1. Reduction in surgical and radiotherapy morbidity by reducing tumour burden and allowing the appropriate selection of patients to undergo post-operative radiotherapy; 2. Provision of immediate information about pathological response and 3. Access to tissue to provide insight into resistance mechanisms and identification of biomarkers of response. The Investigators hypothesized that the use of neoadjuvant Pembrolizumab could reduce tumour burden allowing appropriate selection of patients undergoing radical surgical resection and adjuvant radiotherapy.

Начало: 28.06.2022 Край: 01.06.2027 Възраст: от 18 г. Лечение

Australia Queensland Health NCT05025813

Набира участници

Predicting the Efficacy of Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer Using an AI Platform Based on Multi-parametric MRI

Rectal Cancer

Establish a deep learning model based on multi-parameter magnetic resonance imaging to predict the efficacy of neoadjuvant therapy for locally advanced rectal cancer.This study intends to combine DCE with conventional MRI images for DL, establish a multi-parameter MRI model for predicting the efficacy of CRT, and compare it with the DL and non-artificial quantitative MRI diagnostic model constructed by conventional MRI to evaluate the role of DL in MRI predicting CRT. And this study also tries to build a DL platform to assess the efficacy of LARC neoadjuvant radiotherapy and chemotherapy, accurately assess patients' complete respose (pCR) after CRT, and provide an important basis for guiding clinical decision-making.

Начало: 24.06.2022 Край: 01.12.2027 Възраст: от 18 г.

China Sixth Affiliated Hospital, Sun Yat-sen University NCT05523245

Набира участници Фаза 1/2

Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

Advanced Solid Malignancies

This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in participants with advanced cancer that has recurred/progressed.

Начало: 24.06.2022 Край: 11.08.2027 Възраст: 18–130 г. Лечение

Australia, Germany, South Korea +4 AstraZeneca NCT05417594

Набира участници Ранна Фаза 1

Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma

Gallbladder Adenocarcinoma

Gallbladder adenocarcinoma is a devastating disease associated with a poor prognosis. Gallbladder and other biliary cancers will be responsible for an estimated 11,980 new cases, and 4,090 deaths in the US during 2020. The 5-year survival for all patients with gallbladder cancer is 18%, however this plummets to 2% for patients with metastatic disease. Patients with gallbladder cancer frequently develop peritoneal recurrence, particularly after intra-operative bile spillage during cholecystectomy for incidentally discovered gallbladder malignancy. Once developed, peritoneal metastases are difficult to treat and result in significant morbidity and mortality. As a result, novel approaches that target peritoneal metastases are needed for this disease. Prophylactic use of heated intraperitoneal chemotherapy (HIPEC) has been explored or is under active investigation for numerous gastrointestinal malignancies, including colon, gastric, and appendiceal cancers. HIPEC has efficacy in gallbladder cancer patients with macroscopic peritoneal disease undergoing cytoreductive surgery (CRS)/HIPEC and has been associated with a survival advantage in a multi-institutional retrospective case series. Incidentally discovered gallbladder cancer is treated with central hepatectomy and portal lymphadenectomy, therefore a prophylactic HIPEC can be easily incorporated into the second operation performed as part of the standard of care. In this early phase clinical trial, the investigators will explore the safety and feasibility of prophylactic HIPEC for gallbladder cancer in patients at high-risk of peritoneal recurrence. The primary endpoint is to assess feasibility of the prophylactic heated intraperitoneal chemotherapy (HIPEC) approach in gallbladder cancer. The primary endpoints include occurrence of intra-operative complications, technical challenges, 90-day postoperative morbidity and mortality, length of stay and readmission, which will be documented and compared with historical controls after follow-up.

Начало: 23.06.2022 Край: 01.07.2029 Възраст: от 18 г.

United States West Virginia University NCT05430035

Набира участници Фаза 3

Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age

Cystic Fibrosis

The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Начало: 21.06.2022 Край: 30.06.2030 Възраст: 1–11 г. Лечение

Australia, Canada, France +6 Vertex Pharmaceuticals Incorporated NCT05422222

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