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Набира участници

Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation

Liver Dysfunction

INTERLIVER is a prospective observational study of the relationship of the molecular phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical features and outcomes. A segment of a biopsy performed as standard-of-care for indications, or by center protocol, will be used for gene expression study.

Начало: 19.12.2017 Край: 01.12.2027 Възраст: от 18 г.

Australia, Canada, Poland +2 University of Alberta NCT03193151

Набира участници Фаза 2/3

Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

Systemic Inflammation Cardiopulmonary-bypass

Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.

Начало: 01.11.2017 Край: 31.03.2026 Възраст: от 21 г. Превенция

Australia, Belgium, Germany +7 Alloksys Life Sciences B.V. NCT03050476

Набира участници Фаза 2

A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL)

This is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a B-receptor signaling pathway inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status (Cohort 2).

Начало: 12.10.2017 Край: 01.05.2029 Възраст: от 18 г. Лечение

Australia, China, New Zealand +1 AbbVie NCT02966756

Набира участници

Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis

Familial Adenomatous Polyposis

The purpose of this study is to collect prospective observational data regarding patients with diagnosed Familial Adenomatous Polyposis (FAP) undergoing cold snare polypectomy for duodenal adenomas

Начало: 10.10.2017 Край: 10.10.2028 Възраст: 18–99 г.

Australia Western Sydney Local Health District NCT03471403

Набира участници Фаза 2

APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

Solid Tumors Advanced Cancer Renal Cancer Gastric Cancer +14

To assess: * efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations, NSCLC harboring MET amplification, solid tumors harboring MET amplification, solid tumors harboring MET fusion, primary CNS tumors harboring MET alterations, solid tumors harboring wild-type MET with overexpression of HGF and MET * efficacy of APL-101 as an add-on therapy to EGFR inhibitor for the treatment of NSCLC harboring EGFR activating mutations and developed acquired resistance with MET amplification and disease progression after documented CR or PR with 1st line EGFR inhibitors (EGFR-I)

Начало: 27.09.2017 Край: 30.11.2026 Възраст: от 18 г. Лечение

Australia, Canada, France +8 Apollomics Inc. NCT03175224

Набира участници Фаза 2

International Study for Treatment of High Risk Childhood Relapsed ALL 2010

Acute Lymphoblastic Leukemia (ALL)

The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.

Начало: 01.09.2017 Край: 31.12.2027 Възраст: до 17 г. Лечение

Australia, Belgium, Czechia +10 Charite University, Berlin, Germany NCT03590171

Набира участници

ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study

Colorectal Neoplasm Endoscopic Mucosal Resection

Colonic Laterally spreading lesions (LSL) =\> 20mm are at high risk to progress to cancer. Overt stigmata of submucosal invasive cancer (SMIC) has been well characterized and includes ulceration and surface pit pattern changes as per the Kudo classification of type V. In a recent report, risk factors for LSL with SMIC and no overt stigmata (i.e. covert SMIC) were described. Resection of these lesions 'en-bloc' can allow for better histological staging and potentially reduce the need for surgical resection.

Начало: 14.08.2017 Край: 01.02.2028 Възраст: от 18 г. Лечение

Australia Western Sydney Local Health District NCT04008407

Набира участници

Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma

Submucosal Esophageal Adenocarcinoma Barrett Esophagus High-risk Mucosal Esophageal Adenocarcinoma

Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection (ER) for submucosal or high-risk mucosal esophageal adenocarcinoma (T1bN0M0 or HR T1aN0M0 EAC).

Начало: 25.07.2017 Край: 25.07.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Germany +3 Amsterdam UMC NCT03222635

Набира участници

International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Prostate Cancer

Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.

Начало: 21.07.2017 Край: 01.01.2032 Възраст: от 21 г.

Australia, Barbados, Brazil +11 Prostate Cancer Clinical Trials Consortium NCT03151629

Набира участници Фаза 3

A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Primary Myelofibrosis Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis

This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count \

Начало: 26.06.2017 Край: 30.07.2027 Възраст: от 18 г. Лечение

Australia, Belarus, Bosnia and Herzegovina +21 Swedish Orphan Biovitrum NCT03165734

Набира участници Фаза 3

Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

Childhood Extracranial Germ Cell Tumor Extragonadal Embryonal Carcinoma Germ Cell Tumor Malignant Germ Cell Tumor +26

This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.

Начало: 25.05.2017 Край: 30.06.2027 Лечение

Australia, Canada, India +6 Children's Oncology Group NCT03067181

Набира участници

Focal Radiotherapy for Previously Treated Prostate Cancer Patients

Locally Recurrent Prostate Cancer

To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment (SBRT) for locally recurrent prostate cancer.

Начало: 24.04.2017 Край: 31.03.2027 Възраст: от 18 г. Лечение

Australia Royal North Shore Hospital NCT03073278

Набира участници Фаза 1/2

A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Locally Advanced Solid Tumors Metastatic Solid Tumors

Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Начало: 07.03.2017 Край: 29.02.2028 Възраст: от 12 г. Лечение

Australia, Belgium, Canada +15 Turning Point Therapeutics, Inc. NCT03093116

Набира участници

The Australian Colonic Large Sessile Lesion Endoscopic Resection Study

Colon Adenoma Colon Polyp

A prospective, multicentre, observational study of all patients referred for endoscopic resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat analysis

Начало: 24.02.2017 Край: 01.02.2037 Възраст: 18–99 г.

Australia Western Sydney Local Health District NCT03471793

Набира участници Фаза 1/2

A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma

Non-Hodgkin's Lymphoma

This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-into-human (EIH) study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.

Начало: 21.02.2017 Край: 31.12.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +10 Hoffmann-La Roche NCT03075696

Набира участници

The RESPOND Outcomes Study

HIV

The RESPOND Outcomes study is a research study around use of antiretroviral and other relevant drugs and long-term clinical outcomes in patients living with HIV. Data collected in this study will be used to answer key unanswered questions regarding treatment of people living with HIV.

Начало: 01.01.2017 Край: 01.12.2025 Възраст: от 18 г.

Australia, Belgium, Denmark +7 Rigshospitalet, Denmark NCT04090151

Набира участници

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

Huntington's Disease

HDClarity will seek at least 2500 research participants at different stages of Huntington's disease (HD). The primary objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD. The secondary objective is to generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development.

Начало: 01.01.2017 Възраст: 11–75 г.

Canada, France, Germany +6 University College, London NCT02855476

Набира участници Фаза 2

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer

The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.

Начало: 22.12.2016 Край: 31.07.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +33 Astellas Pharma Global Development, Inc. NCT02960022

Набира участници Фаза 1/2

Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)

Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in participants with metastatic castration resistant prostate cancer (mCRPC). There will be ten cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A), Cohort H will receive pembrolizumab/vibostolimab coformulation, Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2 and Cohort J will receive belzutifan in Arm1 and Pembrolizumab+belzutifan in Arm 2. Outcome measures will be assessed individually for each cohort.

Начало: 17.11.2016 Край: 24.07.2028 Възраст: от 18 г. Лечение

Australia, Canada, Denmark +12 Merck Sharp & Dohme LLC NCT02861573

Набира участници Фаза 2

Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection

Chronic Hepatitis B

The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in children.

Начало: 01.11.2016 Край: 01.10.2029 Възраст: 2–17 г. Лечение

Belgium, Canada, Hong Kong +8 Gilead Sciences NCT02932150

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