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Long-Term Follow-up of People Undergoing Hematopoietic Stem Cell Transplantation

Hematopoietic Stem Cell Transplantation Tissue Donors

Background: People who have had an allogeneic hematopoietic stem cell transplant (HCT) have bone marrow or an immune system that is damaged. They get stem cells from a donor who is a relative. Researchers want to study stem cell donors and recipients to learn about the long-term effects of HCT. They want to learn how the stem cells change and how to improve their ability to fight cancer. Objective: To provide long-term follow-up care for people who underwent or will undergo HCT. To collect data, blood, and tissue samples to learn about late complications after HCT. Eligibility: Adults age 18 and older who will undergo HCT or underwent HCT and are surviving one year or more from the date of HCT. The stem cell donors for these recipients are also needed. Design: Recipients will have 1 visit each year. They will have a physical exam. They will answer questions about their medical history and health. They will receive screening and surveillance testing. They will complete brief questionnaires. Recipients will have blood tests. They may have tissue biopsies or specimens (such as tissue in their cheek or skin or bone marrow biopsy). Recipients will give their current address and phone number, and the same data for one or two other people, who can get in contact with them. After the first visit at the clinic, some recipients may see a doctor close to home to get the necessary information and send it to NIH. Donors will come to the clinic for 1 visit. They will answer questions about their medical history. Blood samples will be taken.

Начало: 26.04.2017 Край: 12.08.2050 Възраст: от 4 г.

United States National Cancer Institute (NCI) NCT03000244

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

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Familial Investigations of Childhood Cancer Predisposition

Acute Leukemia Adenomatous Polyposis Adrenocortical Carcinoma AML +42

NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown in the Eligibility Section, you may enroll regardless of the results of your clinical genetic testing. While it is well recognized that hereditary factors contribute to the development of a subset of human cancers, the cause for many cancers remains unknown. The application of next generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary cancer predisposition. Currently, more than 100 cancer predisposing genes have been identified, and it is now estimated that approximately 10% of all cancer patients have an underlying genetic predisposition. The purpose of this protocol is to identify novel cancer predisposing genes and/or genetic variants. For this study, the investigators will establish a Data Registry linked to a Repository of biological samples. Health information, blood samples and occasionally leftover tumor samples will be collected from individuals with familial cancer. The investigators will use NGS approaches to find changes in genes that may be important in the development of familial cancer. The information gained from this study may provide new and better ways to diagnose and care for people with hereditary cancer. PRIMARY OBJECTIVE: * Establish a registry of families with clustering of cancer in which clinical data are linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues from the proband and other family members. SECONDARY OBJECTIVE: * Identify novel cancer predisposing genes and/or genetic variants in families with clustering of cancer for which the underlying genetic basis is unknown.

Начало: 06.04.2017 Край: 31.03.2037

United States St. Jude Children's Research Hospital NCT03050268

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Scoliosis Shared Decision Making

Scoliosis

Analysis of video encounters between providers, patients, and families will be used to develop a shared decision making tool for patients deciding between surgery and observation for scoliosis treatment.

Начало: 30.03.2017 Край: 01.03.2027 Възраст: от 13 г.

United States Mayo Clinic NCT03107533

Набира участници Фаза 1

The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists

Polycystic Ovary Syndrome

Background: Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy. Objective: To learn more about how BAT works to burn energy. Eligibility: People ages 18-40 with a body mass index between 18 and 40 Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Dietitian interview Participants will have an overnight baseline visit. This includes: Repeats of screening tests Exercise test Scans. For one scan, a radioactive substance is injected into the arm. FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other. Metabolic suite: Participants stay 18-19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature. Optional fat biopsy: A small piece of tissue is removed with a needle. Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo. All participants will have a visit after 2 weeks of the pills. They will repeat the screening tests. Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests. Participants will keep food and medication diaries. Participants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests.

Начало: 13.03.2017 Край: 30.09.2026 Възраст: 18–40 г.

United States National Institute of Diabetes and Digestive and Kidney NCT03049462

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

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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

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Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI

Cancer Related Cognitive Difficulties Breast Cancer Female

Study is enrolling newly diagnosed breast cancer patients about to start chemotherapy and age-matched control participants. The investigator is trying to better understand the prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared to the general population as well as what biological mechanisms may play a role in the development of these difficulties. Patients will be asked to complete six assessments over the course of approximately 5 months. Assessments 1,3, 4.5 and 5 include computerized and paper and pencil cognitive testing as well as blood draws. Assessments 2 and 4 only involve the collection of a blood sample. An optional sub study is offered after Assessment 1. It involves a research brain MRI at Assessment 4.5 and cognitive testing and another research brain MRI at Assessment 6.

Начало: 20.02.2017 Край: 31.07.2027 Възраст: от 21 г.

United States University of Rochester NCT03137095

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Retinoblastoma Patient Clinical Database and Tissue Repository

Retinoblastoma Retinoblastoma Bilateral Retinoblastoma Unilateral

Retinoblastoma (RB) is a primary eye cancer that forms in the back of the eye of infants and toddlers. Traditionally, RB is diagnosed without a biopsy; tumor can only be studied once an eye has been surgically removed. Given this limitation, we use aqueous humor (AH), the clear fluid in the front of the eye to detect specific markers, or information, that comes from the tumor itself.

Начало: 01.01.2017 Край: 31.12.2030 Възраст: до 18 г.

Canada, United States Children's Hospital Los Angeles NCT04959097

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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

Prospective Cohort for Adult Hemophagocytosis

Hemophagocytic Lymphohistiocytoses

This prospective study enrolls subjects who have clinical and laboratory manifestations related with hemophagocytic lymphohistiocytosis. The purpose of the study is to evaluate clinical and biological features of adult hemophagocytic lymphohistiocytosis. The enrolled subjects into this study will be evaluated according to the HLH (hemophagocytic lymphohistiocytosis)criteria and treated with systemic immunosuppressive therapy or chemotherapy. All subjects will be regularly monitored by physicians participating in this study.

Начало: 01.01.2017 Край: 31.12.2028 Възраст: 18–80 г.

South Korea Samsung Medical Center NCT03117010

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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

Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge

Malaria

Background: Malaria is a serious infection caused by a parasite. People get malaria when an infected mosquito bites them. Malaria can cause major health and social problems in places were malaria is common, such as Africa but can also affect travelers who have never been exposed to malaria. Researchers at the NIH want to find a safe and effective malaria vaccine, antimalarial drugs, or prevention regimen. To do this, healthy volunteers are recruited under a general screening study in order to see if are qualified to join a future malaria study. Objective: To screen healthy volunteers to see if they are eligible to join investigational malaria studies. The studies will be trials of investigational antimalarial drugs, malaria vaccines, or prevention regimens. They may also involve controlled human malaria infection trials. Eligibility: Healthy people ages 18 50 Design: Participants will first be prescreened by phone. Participants will be screened with: Medical history Physical exam Blood and urine tests Participants may go more than 1 year without joining a clinical trial. If this happens, they may be re-contacted to see if they still want to be part of this screening protocol. Those who still want to participate and have had relevant medical changes will be rescreened.

Начало: 08.12.2016 Край: 30.09.2030 Възраст: 18–50 г.

United States National Institute of Allergy and Infectious Diseases ( NCT02639299

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Neurovascular Product Surveillance Registry

Intracranial Aneurysm Stroke, Ischemic

Post market surveillance registry

Начало: 01.12.2016 Край: 01.08.2032 Възраст: от 18 г.

Argentina, Australia, Austria +21 Medtronic Neurovascular Clinical Affairs NCT02988128

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Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia

Metabolic Disease Propionic Acidemia Organic Acidemia

Background: People s bodies need to break down food into the chemicals. These chemicals are used for energy and growth. Some people cannot process all chemicals very well. Too much of some chemicals can cause diseases. One of these diseases is called propionic acidemia (PA). People with PA can have problems with growth, learning heart, abdomen, and other organs. Researchers want to better understand how these problems happen. Objective: To learn more about propionic acidemia and the genes that might contribute to it. Eligibility: People at least 2 years old with PA who can travel to the clinic Some unaffected family members Design: Participants will have a 3 to 5-day hospital visit every year or every few years. Family members may have just 1 visit. During the family member visit, they may have: Medical history Physical exam Samples of blood and urine Questions about diet and a food diary Doctors and nurses may do additional studies: Samples of saliva, skin and stool Fluid from a gastronomy tube, if participants have one Dental and eye evaluations A kidney test - a small amount of dye will be injected and blood will be collected. Consultations with specialists A test of calories needed at rest. A clear plastic tent is placed over the participant to measure breathing. Stable isotope study. Participants will take a nonradioactive substance then blow into a bag. Photos taken of the face and body with underwear on Ultrasound of the abdomen Heart tests Hand x-ray Brain scan Participants may have other tests if study doctors recommend them. They will get the results of standard medical tests and genetic tests.

Начало: 29.11.2016 Край: 31.08.2036 Възраст: 1–100 г.

United States National Human Genome Research Institute (NHGRI) NCT02890342

Набира участници

Impact of Complete Surgery of Colorectal Deep Infiltrating Endometriosis on Fertility

Endometriosis Infertility

The ENDOFERT Study is an open, multicenter, randomized, parallel-group, controlled trial. This study includes patients presenting colorectal DIE and infertility. Patients will be randomized in two parallel-groups; one group underwent complete surgery of colorectal DIE prior to ART and the other group underwent ART alone (ratio 1:1)

Начало: 17.11.2016 Край: 01.05.2026 Възраст: 18–38 г.

France University Hospital, Lille NCT02948972

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 Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma

Lymphoma

The purpose of this study is to test any good and bad effects of the study drug called ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with another protein called STAT and is important for survival of many T or NK-cell lymphomas. By blocking JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.

Начало: 01.11.2016 Край: 01.11.2027 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT02974647

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