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Набира участници Фаза 2

Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma

Pheochromocytoma Paraganglioma Neuroendocrine Tumors Neuroendocrine Neoplasms

Background: Pheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and there are no good treatments if the disease has spread. Researchers think a new drug may be able to help. Objective: To learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the length of time it takes for the cancer to return. Eligibility: Adults who have an inoperable tumor of the study cancer that can be detected with Ga-68-DOTATATE PET/CT imaging Design: Participants will be screened with a medical history, physical exam, and blood tests. Eligible participants will be admitted to the NIH Clinical Center. Participants will get the study drug in an intravenous infusion. They will get 4 doses, given about 8 weeks apart. Between 4 and 24 hours after each study drug dose, participants will have scans taken. They will lie on their back on a scanner table. Participants will have vital signs taken. They will give blood and urine samples. During the study, participants will have other scans taken. Some scans will use a radioactive tracer. Participants will complete quality of life questionnaires. Participants will be contacted by phone 1-3 days after they leave the Clinical Center. They will then be followed every 3 to 6 months for 3 years or until their disease gets worse.

Начало: 10.10.2017 Край: 01.01.2033 Възраст: 18–100 г.

United States National Cancer Institute (NCI) NCT03206060

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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

Molecular Epidemiology of Biliary Tree Cancers

Cholangiocarcinoma Malignant Digestive System Neoplasm

This study is to learn if certain risk factors (environmental, viral, behavioral, medical, and dietary), tumor markers, and genetic changes can predict the development and outcome of biliary tree cancers. Establishing biomarkers models from patients may help doctors to further understand how biliary tree cancer is affected by different treatments, and why some people's cancer responds differently than others.

Начало: 25.09.2017 Край: 02.02.2027

United States M.D. Anderson Cancer Center NCT05179486

Набира участници Фаза 1/2

Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients

Pancreatic Cancer Gastric Cancer Gastrointestinal Cancer Colon Cancer +1

Background: A new cancer therapy involves taking white blood cells from a person, growing them in the lab, genetically modifying them, then giving them back to the person. This therapy is called gene transfer using anti-KRAS G12V mTCR cells. Objective: To see if anti-KRAS G12 V mTCR cells are safe and can shrink tumors. Eligibility: Adults at least 18 years old with cancer that has the KRAS G12V molecule on the surface of tumors. Design: In another protocol, participants will: Be screened Have cells harvested and grown Have leukapheresis In this protocol, participants will have the procedures below. Participants will be admitted to the hospital. Over 5 days, participants will get 2 chemotherapy medicines as an infusion via catheter in the upper chest. A few days later, participants will get the anti-KRAS G12V mTCR cells via catheter. For up to 3 days, participants will get a drug to make the cells active. A day after getting the cells, participants will get a drug to increase their white blood cell count. This will be a shot or injection under the skin. Participants will recover in the hospital for 1-2 weeks. They will have lab and blood tests. Participants will take an antibiotic for at least 6 months. Participants will have visits every few months for 2 years, and then as determined by their doctor. Visits will be 1-2 days. They will include lab tests, imaging studies, and physical exam. Some visits may include leukapheresis or blood drawn. Participants will have blood collected over several years.

Начало: 21.09.2017 Край: 29.06.2028 Възраст: 18–72 г.

United States National Cancer Institute (NCI) NCT03190941

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Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research

Endothelial Dysfunction Inflammation in Cardiopulmonary and Vascular Disease States Healthy Volunteers

Background: This study is designed to provide samples to help us study the genes your blood cells are making as well as the proteins, sugars, fats, vitamins and other metabolites found in your blood or urine. Blood samples may also be collected to make special cells. These are called induced pluripotent stem cells or iPSCs. Pluripotent stem cells are cells that can be converted into any type of cell. Researchers want to study in the lab iPSCs that are derived from blood samples. Objective: To collect samples to help study genes, proteins, sugars, fats, vitamins, and other metabolites found in blood or urine. Eligibility: Healthy volunteers and patients ages 18 and older Design: First-time research study participants at NIH will have an initial visit for this study that should last no more than 1 hour. All other visits should last 20 30 minutes. Participants will undergo a limited history and physical exam. Participants may have routine blood and urine tests. If participants are giving a blood sample, they must have a hemoglobin level checked in the past 12 months to make sure it is safe for them to give a blood sample for research. Participants may have a venous blood collection. They may do this at several visits. They will lie on a recliner or couch or sit in a chair. A needle will be placed into a vein in the hand or arm, using sterile techniques. Blood will be withdrawn into multiple syringes or tubes. Participants may be asked to provide urine in an appropriate container...

Начало: 14.09.2017 Край: 01.08.2027 Възраст: 18–100 г.

United States National Institutes of Health Clinical Center (CC) NCT03253705

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

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Sample Collection and Tracking for the Developmental Therapeutics Clinic

Neoplasms Lymphoma

Background: People who join a study in the Developmental Therapeutics Clinic (DTC) have tests. These include blood draws and biopsies. Researchers collect data from these samples. Some people take part in more than one study at the DTC. At this time, data are connected only with one single study. Researchers want to access people s medical records. This will allow them to link the research data from all their studies they have or will take part in. Researchers also want to collect medical data about their diagnosis and treatment history. This will allow them to see how their cancer reacted to different drugs over time. Objective: To enter people into a master protocol to connect research sample and treatment data across DTC studies. Eligibility: People ages 18 and older who are being evaluated or treated for cancer in the DTC Design: Participants will allow researchers to look at all the data from their research samples. This includes those from their current, past, and any future NIH studies. Participants will allow researchers to access some of their medical data. This includes age, diagnosis, treatment history, and response to treatment. Participants will provide no new samples. ...

Начало: 28.08.2017 Край: 30.05.2027 Възраст: 18–120 г.

United States National Cancer Institute (NCI) NCT03269578

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Cognitive Training Intervention and Attitudes Towards Genetics

Cognitive Impairment Hematologic Neoplasms Hematopoietic Cell Transplant

A pilot study to evaluate feasibility of enrollment of patients in an intervention to improve neurocognitive function in hematopoietic cell transplantation (HCT) survivors using the cognitive training Lumosity program. In addition, patients' interest in receiving information regarding genetic risk of cognitive impairment post-HCT will be measured.

Начало: 21.08.2017 Край: 01.07.2027 Възраст: от 21 г.

United States University of Alabama at Birmingham NCT03094026

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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

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NIAID Centralized Sequencing Protocol

Atopy Primary Immunodeficiency Autoimmunity Autoinflammation

Background: Genetic testing called "sequencing" helps researchers look at DNA. Genes are made of DNA and are the instructions for our bodies to function. We all have thousands of genes. DNA variants are differences in genes between two people. We all have lots of variants. Most are harmless and some cause differences like blue or brown eyes. A few variants can cause health problems. Objective: To understand the genetics of immune disorders various health conditions, as well as outcomes of clinical genomics and genetic counseling services performed under this protocol. Eligibility: Participants in other NIH human subjects research protocols - either at the NIH Clinical Center (CC) or at Children s National Health System (CNHS) - (aged 0-99 years), and, in select cases, their biological relatives Design: Researchers will study participant s DNA extracted from blood, saliva, or another tissue sample, including previously collected samples we may have stored at the NIH. Researchers will look at participant s DNA in great detail. We are looking for differences in the DNA sequence or structure between participants and other people. Participants will receive results that: * Are important to their health * Have been confirmed in a clinical lab * Suggest that they could be at risk for serious disease that may affect your current or future medical management. Some genetic information we return to participants may be of uncertain importance. If genetic test results are unrelated to the participant s NIH evaluations, then we will not typically report: * Normal variants * Information about progressive, fatal conditions that have no effective treatment * Carrier status (conditions you don t have but could pass on) The samples and data will be saved for future research. Personal data will be kept as private as possible. If future studies need new information, participants may be contacted.

Начало: 31.07.2017 Край: 31.12.2029 Възраст: 1–100 г.

United States National Institute of Allergy and Infectious Diseases ( NCT03206099

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Clonal Evolution in Follicular Lymphoma

Follicular Lymphoma

Background: Follicular lymphoma is a type of cancer of the lymph nodes. Lab studies are important for cancer research. They help scientists better understand differences in the cancer biology of different patients. Researchers want to collect serial samples over time from people with follicular lymphoma to help them design future treatments. Objective: To collect a variety of samples from people with follicular lymphoma to study how these diseases progress and respond to treatment. Eligibility: Adults at least 18 years old who have been diagnosed with, but have not yet had any treatment for, follicular lymphoma. Design: Participants will be screened with medical history and physical exam. They will answer questions about daily functioning. They will have blood and urine tests. They may have scans and have tissue samples taken. Participants will be monitored about every 4 months for up to 2 years. They will repeat screening tests. They will have a cheek swab. A small brush will be rubbed against the inside of the cheek to wipe off some cells. Participants will have imaging scans about every 8 months for up to 2 years. Participants may have a bone marrow aspiration and biopsy. The hipbone will be numbed with a small needle. A needle will be put into the hipbone, and about 2 tablespoons of bone marrow will be taken out through the needle. Participants will continue being monitored every 6 months for up to 5 years, then 1 time a year. ...

Начало: 27.07.2017 Край: 01.01.2029 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT03190928

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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

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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

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Swiss Paediatric Airway Cohort

Asthma Wheezing Cough Exercise Induced Bronchospasm +2

The Swiss Paediatric Airway Cohort (SPAC) is a national, prospective clinical cohort of children and adolescents who visit physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory problems. SPAC aims to answer important questions on clinical phenotypes, prognosis, diagnosis and treatment. SPAC is part of routine care, and only clinically indicated investigations are done. The comprehensive baseline assessment includes a detailed questionnaire to families, plus test results, diagnoses and treatments from hospital records. Follow-up is via monthly questionnaires the first 12 months and thereafter annual questionnaires to families, and data from follow-up visits. Currently, 4344 patients from 10 clinics and hospitals in Switzerland (Aarau, Basel, Bern, Chur, Horgen, Lausanne, Luzern, St. Gallen, Worb, Zurich) have been enrolled. SPAC provides real-life data on children visiting the Swiss health care system for common respiratory problems. It will provide a research platform for health services research, and for nested clinical and transitional studies. Publications and plain language summaries are listed on the study website: https://www.spac-study.ch/publikationen/

Начало: 06.06.2017 Край: 01.06.2030 Възраст: до 16 г.

Austria, Switzerland University of Bern NCT03505216

Набира участници Фаза 4

Taper Or Abrupt Steroid Stop: TOASSTtrial

Inflammatory Disorder Autoimmune

This study is an Investigator-initiated, placebo-controlled, multicenter noninferiority trial, comparing rapid termination of systemic glucocorticoid treatment with a tapering regime over 4 weeks.

Начало: 31.05.2017 Край: 01.06.2027 Възраст: от 18 г.

Germany, Switzerland University Hospital, Basel, Switzerland NCT03153527

Набира участници Фаза 1

Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder

Healthy Volunteer Major Depressive Disorder Depression

Background: Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect. Objective: Main Study: To study the effects of ketamine in treating depression. Ketamine Metabolites Substudy: To study how ketamine effects brain chemistry. To study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down. Eligibility: Main Study: People ages 18-65 with major depressive disorder and healthy volunteers Ketamine Metabolites Substudy: Healthy volunteers ages 18-65 Design: Main Study: Participants will be screened in another study, with: * Medical and psychiatric history * Psychiatric and physical exam * Blood, urine, and heart tests Participants will be inpatients at NIH for 4 phases totaling 14-20 weeks. Phase I (2-7 weeks): * Gradually stop current medications * MRI: Participants lie and perform tasks in a machine that takes pictures of the body. * Mood and thinking tests * Blood and urine tests * Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep. * Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity. * Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks. Phase I tests are repeated in Phases II and III and in the final visit. Phase II (4-5 weeks): * 4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity. Phase III (optional): * 8 infusions of ketamine over 4 weeks Phase IV (optional): * Symptoms monitoring for 4 weeks * Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months. Ketamine Metabolites Substudy: Participants will be screened in another study, with: * Medical and psychiatric history * Psychiatric and physical exam * Blood, urine, and heart tests Participants will be inpatients at NIH for 4 days. Study Procedures: Mood and thinking tests Blood and urine tests 1 infusion of ketamine Spinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry

Начало: 25.05.2017 Край: 01.01.2028 Възраст: 18–65 г.

United States National Institute of Mental Health (NIMH) NCT03065335

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

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SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access

All Tumor Types

SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care.

Начало: 03.05.2017 Край: 01.10.2031 Възраст: от 12 г.

Austria, Belgium, Croatia +17 European Organisation for Research and Treatment of Can NCT02834884

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