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International Consortium for Multimodality Phenotyping in Adults With Non-compaction

Non-Compaction Cardiomyopathy

Non-compaction cardiomyopathy (NCCM) is a heterogeneous, poorly understood disorder characterized by a prominent inner layer of loose myocardial tissue, and associated with heart failure, stroke, severe rhythm irregularities and death. For a growing population diagnosed with NCCM there is a need for better risk stratification to appropriately allocate (or safely withhold) these impactful preventive measures. The goal of this international consortium is to improve care of patients with non-compaction cardiomyopathy. We hypothesize that comprehensive analysis of clinical, genetic, structural and functional information will improve risk stratification. In addition, we hypothesize that detailed structural analysis will allow for differentiation of pathological and benign patterns of non-compaction. In a large cohort of adult patients with suspected NCCM we will perform in-depth phenotyping, including clinical information, pedigree data, genetics, echocardiography and MRI, and follow patients for up to 3 years. We will apply machine-learning based analytics to develop predictive models and compare their performance to currently used models and treatment criteria. Secondly, in a subset of patients we will perform high-resolution cardiac CT for detailed structural characterization of the myocardial wall. We will investigate associations between myocardial structure and regional contractile function, as assessed by echo and MRI. The aim of this proposal is to identify a structural signature associated with pathological non-compaction and improve developed risk prediction models. Discovery of pathological structural signatures through innovative imaging techniques, in relation to myocardial contractility, will advance our understanding of NCCM.

Начало: 01.01.2021 Край: 01.04.2030 Възраст: от 18 г.

Netherlands, South Korea, United States Stanford University NCT04424030

Активно (без набиране) Фаза 2

Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer

Breast Cancer Breast Neoplasms

This is a Phase II, randomized, open-label trial to evaluate the clinical and immunologic activity of pembrolizumab plus chemotherapy when combined with various immunotherapy induction regimens as neoadjuvant therapy for triple negative breast cancer (TNBC).

Начало: 30.12.2020 Край: 01.12.2026 Възраст: от 18 г.

United States Providence Health & Services NCT04373031

Активно (без набиране) Фаза 2

A Study to Assess Safety and Efficacy of PRL3-Zumab in Patients With Solid Tumors

Solid Tumor

This is a multi-center, Phase 2, open-label, single dose level study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumor.

Начало: 12.12.2020 Край: 01.12.2026 Възраст: от 18 г.

United States Intra-IMMUSG Pte Ltd NCT04452955

Активно (без набиране) Фаза 1/2

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat

Sickle Cell Disease Hemolytic Anemia

Background: Sickle cell disease (SCD) is a disorder that causes episodes of acute pain and progressive organ damage. Ways to manage SCD have evolved slowly. Treatments do not always work. Researchers want to see if a drug called mitapivat can help people with SCD. Objective: To test the long-term tolerability and safety of mitapivat (or AG-348) in people with SCD. Eligibility: Adults age 18-70 with SCD who took part in and benefited from NIH study #19H0097. Design: Participants will be screened with a medical history and physical exam. They will give a blood sample. They will have an electrocardiogram to test heart function. Participants will repeat some of the screening tests during the study. Participants will complete 6-minute walk tests to measure mobility and function. They will have transthoracic echocardiograms to measure heart and lung function. They will have dual-energy X-ray absorptiometry scans to measure bone health. They will complete online questionnaires that measure their overall health and well-being. Participants will take the study drug in the form of a tablet twice a day. Participants will keep a study diary. They will record any symptoms they may have. Participation will last for about 54 weeks. After 48 weeks, participants can either keep taking the study drug for 48 more weeks or be tapered off of the study drug to complete the study. Those who are on the study for 1 year will have 10 study visits. Those who are on the study for 2 years will have 14 study visits.

Начало: 09.12.2020 Край: 28.02.2028 Възраст: 18–70 г.

United States National Heart, Lung, and Blood Institute (NHLBI) NCT04610866

Активно (без набиране) Фаза 1

Testing a New Imaging Agent to Identify Cancer

HER-2 Positive Malignant Carcinoma of Breast HER-2 Protein Overexpression HER2-positive Metastatic Breast Cancer

The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.

Начало: 30.11.2020 Край: 30.11.2026 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT04692831

Активно (без набиране)

Non-ischemic Preservation of the Donor Heart in Heart Transplantation

Heart Transplantation

The study intends to compare standard ischemic cold static storage (ICSS) of retrieved hearts intended to be transplanted, to non-ischemic heart preservation (NIHP) in a randomized clinical multicentre trial. The primary hypothesis is that the non-ischemic hypothermic cardioplegic preservation (NIHP) is safe and superior to ischemic cold static storage (ICSS) of donor hearts. The study will investigate the safety and superiority of the new methodology in terms of improved immediate and prolonged organ function in adult heart transplanted patients.

Начало: 25.11.2020 Край: 31.12.2028 Възраст: 18–70 г.

Austria, Belgium, France +5 XVIVO Perfusion NCT03991923

Активно (без набиране) Фаза 2

A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma

Melanoma Stage III

In many cancers, early stage diagnosis and early treatment offers the best chance of a prolonged recurrence free- and overall survival. In stage III/IV resectable melanoma, an opportunity exists to improve outcomes with the addition of neoadjuvant and adjuvant systemic therapy as an adjunct to surgery. Neoadjuvant clinical trials for resectable but bulky stage III/IV melanoma allows for the efficient and rapid evaluation of drug activity in humans utilising multiple clinical endpoints of metabolic, radiological and pathological response; relapse-free survival; overall survival.

Начало: 11.11.2020 Край: 01.01.2033 Възраст: 18–115 г. Лечение

Australia Melanoma Institute Australia NCT04207086

Активно (без набиране) Фаза 3

Sacituzumab Govitecan in Primary HER2-negative Breast Cancer

HER2-negative Breast Cancer Triple Negative Breast Cancer

Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to: * Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles); * Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation. Treatment in either arm will be given for eight cycles. In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents. Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting.

Начало: 28.10.2020 Край: 30.03.2029 Възраст: 18–99 г.

Austria, Belgium, France +4 GBG Forschungs GmbH NCT04595565

Активно (без набиране) Фаза 2

A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type

Extranodal NK/T-cell Lymphoma, Nasal Type Extranodal NK/T-cell Lymphoma

This is a phase 2, Open-label, to investigate the efficacy and safety of IMC-001 in patients with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type

Начало: 27.10.2020 Край: 28.02.2027 Възраст: от 18 г.

South Korea ImmuneOncia Therapeutics Inc. NCT04414163

Активно (без набиране)

Radiosurgery With or Without Whole Brain Radiation for Multiple Metastases

Brain Metastases

This clinical study is a parallel, prospective observational single-centre trial in patients presenting with 5 to 30 brain metastases. Patients to receive either stereotactic radiosurgery (SRS) alone or SRS plus whole brain radiation (WBRT) will be enrolled.

Начало: 20.10.2020 Край: 01.12.2027 Възраст: от 18 г.

Canada Sunnybrook Health Sciences Centre NCT03775330

Активно (без набиране)

Assessment of Safety and Performances of HYPE SCS Stem Associated to NOVAE Sunfit TH Acetabular Cup in Hip Arthroplasty

Hip Arthropathy

Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures. HYPE SCS stems are intended to be used for primary total hip arthroplasties to reduce pain and restore joint mobility of the hip. Clinical data for HYPE SCS available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product. Thus, in order to maintain compliance with the EU regulation (2017/745) relating to medical devices and following MEDDEV 2.7.1.guidelines, SERF has set up post-market clinical follow-ups (PMCF). This PMCF study aims to generate clinical data in order to confirm these performance of HYPE SCS Stem associated to NOVAE Sunfit TH acetabular cup. In the meantime, through complications faced over the entire period of the study, risks related to the implantation of HYPE SCS stems will be assessed at medium term (5 years). It should be noted that this patient cohort reflects the usual medical care of Hospital Center "J. Monod" of Flers.

Начало: 13.10.2020 Край: 01.03.2027 Възраст: от 18 г.

France Societe dEtude, de Recherche et de Fabrication NCT05524363

Активно (без набиране)

Social Experiences of Adolescents and Young Adults With Cancer

Childhood Cancer Social Behavior Social Competence

Participants are being asked to take part in this clinical trial, a type of research study, because investigators want to learn more about the social experiences adolescents and young adults who are being treated or have been treated for cancer. Primary Objectives * Describe differences in social experience variables (peer connectedness, perceived social competence, parent versus peer attachment) based on treatment status: on versus off therapy. * In on-therapy patients, describe differences in social experience variables (peer connectedness, perceived social competence, parent versus peer attachment) based on developmental stage: high school versus post-high school. Secondary Objectives * Assess the social support and peer interaction needs of AYA with cancer as a means of determining stakeholder interest and need for psychosocial interventions targeting social experiences. * Using qualitative interviews, explore patient perceptions of the impact of cancer on social experiences among AYA, particularly with regards to changes in friendships as a result of the cancer diagnosis and the role of the hospital in helping or hindering friendship maintenance/development. Exploratory Objectives * Explore differences in social experience by demographic, disease and treatment factors, including: gender, diagnostic category (brain tumor, leukemia/lymphoma, solid tumor), late effects/symptom burden, and treatment (e.g., treatment intensity, serious medical events). * Explore associations between perceived impact of cancer and social experience in AYA. * Explore associations between use of social media and social experience. * Explore associations between social experiences and overall functioning (quality of life, distress, coping). * Explore the possibility of subclasses of AYA by using person-centered analyses to empirically derive profiles of social experience.

Начало: 12.10.2020 Край: 01.12.2026 Възраст: 15–22 г.

United States St. Jude Children's Research Hospital NCT04328350

Активно (без набиране)

Enhancing Frontal Lobes Plasticity in Mild Cognitive Impairment

Mild Cognitive Impairment Memory Impairment

More than 5 million people live with Alzheimer's dementia (AD) in North America. No effective treatment exists yet probably because by the time AD has developed it is too late to intervene. Mild Cognitive Impairment (MCI) is a clinical state that typically precedes AD. In MCI, the prefrontal cortex supports compensatory mechanisms that depend on robust synaptic plasticity and that delay progression to AD. Using a neurostimulation approach that enhances prefrontal cortical plasticity in vivo, this project aims to enhance prefrontal cortical plasticity and function in patients with MCI. If successful, this project would discover a treatment modality that enhances compensation in MCI and ultimately, prevents progression to AD.

Начало: 12.10.2020 Край: 01.12.2026 Възраст: от 60 г.

Canada Centre for Addiction and Mental Health NCT04583215

Активно (без набиране) Фаза 1

Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

Cholangiocarcinoma Chondrosarcoma Glioma Any Solid Tumor

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 132 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangiocarcinoma.

Начало: 01.10.2020 Край: 01.05.2026 Възраст: от 18 г. Лечение

Australia, France, Hong Kong +6 Eli Lilly and Company NCT04521686

Активно (без набиране)

The TriggerHappy Trial

Trigger Finger Trigger Thumb Minimally Invasive Surgery

This is a prospective randomized multicenterstudy focusing on PROMs after primary corticoid injection for triggerfinger with a comparison of two different injection techniques.

Начало: 01.10.2020 Край: 01.07.2028 Възраст: от 18 г.

Sweden Sahlgrenska University Hospital NCT04568993

Активно (без набиране) Фаза 3

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung

The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

Начало: 30.09.2020 Край: 30.11.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +25 Janssen Research & Development, LLC NCT04487080

Активно (без набиране)

Supportive Oncology Care At Home RCT

Pancreatic Cancer GastroEsophageal Cancer Rectal Cancer Head and Neck Cancer +1

This research study is evaluating a program that entails remote monitoring and home-based care for people with cancer who are receiving chemotherapy, radiotherapy, or chemoradiotherapy.

Начало: 16.09.2020 Край: 31.12.2026 Възраст: от 18 г.

United States Massachusetts General Hospital NCT04544046

Активно (без набиране)

The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology

Healthy Adults

The proposed research is an intervention and feasibility pilot trial designed to determine if short-term consumption of healthy cookies made with an oil rich in linoleic acid can influence mitochondria biology in white blood cells and muscle. The hypothesis of the study is that consuming 1 healthy cookie rich in linoleic acid each day for two weeks will improve mitochondrial biology in white blood cells and muscle.

Начало: 07.09.2020 Край: 01.12.2026 Възраст: от 18 г.

United States Ohio State University NCT04677920

Активно (без набиране)

Integrated Genomic Prostate Score With MRI Targeted Prostate Biopsies

Prostate Cancer

Background: Prostate cancer is one of the most common cancers in men. For some men, their cancer is monitored. Others have surgery to remove the prostate. Focal therapy is another treatment option. It treats the areas of cancer selectively, which leaves the rest of the prostate intact. This can help lessen side effects. Men who get focal therapy must be chosen carefully. The Oncotype DX Genomic Prostate Score (GPS) assay tests biopsy samples for certain cancer-related genes. It then then gives a score from 1 to 100 to predict the likelihood of poor outcomes. The GPS is used to choose men for focal therapy. Researchers want to test the GPS further. Objective: To assess how GPS may be useful when used with MRI to improve how men are chosen for focal therapy of prostate cancer. Eligibility: Men age 18 and older who had NCCN low or intermediate risk prostate cancer and had MRI and radical prostatectomy at the Urologic Oncology Branch, National Cancer Institute and collaborating centers. Design: This is a multisite study. It will review data and samples that were collected in the past. Samples and images from up to 277 participants will be used. Tumor tissue will be tested with the GPS. Data such as age at diagnosis, race, biopsy results, and pathology results will be merged with the GPS results. Data will be entered into an in-house electronic system. It will be password protected. All data will be kept in secure sites that comply with NIH security standards.

Начало: 02.09.2020 Край: 01.07.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT04541030

Активно (без набиране)

Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient

Cognitive Decline Cognitive Change Cognitive Impairment Postoperative Delirium +2

The research team is creating a foundational infrastructure in order to develop a precision medicine approach for geriatric patients who require surgery with anesthesia. The team plans to build the first of its kind comprehensive database of demographic and risk factor questionnaire responses, biobanked blood specimens, intraoperative electroencephalography (EEG), and inclusive cognitive testing throughout patient interaction starting at the preop appointment until a year later. This will be used to create a predictive model of periooperative neurocognitive disorders.

Начало: 01.09.2020 Край: 30.08.2030 Възраст: от 65 г.

United States Stanford University NCT03839784

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