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Patient-Reported Outcome Version of the Common Criteria for Adverse Events

Survivorship Cancer

Childhood cancer survivors are vulnerable to treatment-related late effects, including physical and psychosocial morbidities, subsequent malignancies, and premature death. Symptom assessment provides a unique insight into survivorship care since symptoms not only indicate the manifestation for the occurrence of chronic health conditions, but also impact quality of life and survival. The National Cancer Institute (NCI) has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to assess symptomatic adverse events (AEs) for adult-onset cancer patients who are receiving cancer therapies. However, content-appropriate and clinically validated symptom assessment tools for adult survivors of childhood cancer are not available. Primary Object 1: Establish content validity for the PRO-CTCAE-SCC Primary Objective 1A: Conduct a symptom selection process through qualitative research to identify symptomatic AEs for adult survivors of childhood cancer Primary Objective 1B: Create symptomatic AE items for adult survivors of childhood cancer based on the prevalence and clinical importance ratings on the items Primary Objective 2: Validate the PRO-CTCAE-SCC using psychometric methods and objective clinical parameters Primary Objective 2A: Test dimensionality for the PRO-CTCAE-SCC Primary Objective 2B: Test clinical validity for the PRO-CTCAE-SCC Primary Objective 2C: Test responsiveness to change for the PRO-CTCAE-SCC Secondary Objective 1: Increase clinical usefulness of the PRO-CTCAE-SCC Secondary Objective 2: Establish meaningful cut-points and minimally important differences (MIDs) on symptom burden scores for clinical decision-making

Начало: 16.12.2019 Край: 01.07.2027 Възраст: от 16 г.

United States St. Jude Children's Research Hospital NCT04050072

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Cold Agglutinin Disease Real World Evidence Registry

Cold Agglutinin Disease (CAD) Cold Agglutinin Syndrome (CAS)

This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 \[NCT02502903,CAD patients\], BIVV009-03/EFC16215 \[NCT03347396\], and BIVV009-04/EFC16216 \[NCT03347422\]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.

Начало: 12.12.2019 Край: 02.11.2028 Възраст: от 18 г.

Austria, France, Germany +5 RECORDATI GROUP NCT05791708

Активно (без набиране) Фаза 1

GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases

Brain Metastases Leptomeningeal Metastasis

This study will test the safety of the study drug, GDC-0084, in combination with radiation therapy in people who have solid tumor brain metastases or leptomeningeal metastases. All participants will have cancer with a PIK3CA mutation. The researchers will test increasing doses of GDC-0084 to find the highest dose that causes few or mild side effects in participants. The study will also try to find out if the combination of the study drug with radiation is effective against participants' cancer.

Начало: 06.12.2019 Край: 01.12.2026 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT04192981

Активно (без набиране) Фаза 2

Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer

Prostate Cancer

Background: People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery. Objective: To test if a PET/CT scan before the prostate gland is removed can predict if prostate cancer will return. Also, to test if this approach is better or worse than the usual approach for prostate cancer. Eligibility: Men ages 18 and older with prostate cancer that appears to be contained within the prostate but is at risk of having spread Design: Participants will be screened with: * Medical history * Blood tests * CT and MRI scans: Participants will lie in a machine. The machine will take pictures of the body. * Bone scan Participants will have a radiotracer injected into a vein. They will have a PET/CT scan of their whole body 60-90 minutes later. During the scan, they will lie on their back and stay still. Within 60 days after the scan, participants will have surgery. This will remove the prostate gland and lymph nodes around it. Some tissue will be used for genetic testing. If the PET/CT scan suggests the cancer has spread, participants may need to have another biopsy within 60 days after the scan. After surgery, participants will have follow-up visits for 5 years. They will have 5 visits the first year and 2 the second. Then they will have visits once a year. If participants cancer returns, they will have repeat PET/CT scans.

Начало: 04.12.2019 Край: 19.11.2027 Възраст: 18–99 г.

United States National Cancer Institute (NCI) NCT03976843

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Mechanisms of Prediabetic States in Sleep Apnea

Sleep Apnea Pre-diabetes

The purpose of this study is to better understand how sleep apnea contributes to the development of diabetes.

Начало: 26.11.2019 Край: 15.07.2026 Възраст: 20–65 г.

United States University of Chicago NCT04234217

Активно (без набиране) Фаза 3

Single Fraction Stereotactic Radiosurgery Compared With Fractionated Stereotactic Radiosurgery in Treating Patients With Resected Metastatic Brain Disease

Metastatic Malignant Neoplasm in the Brain

This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.

Начало: 19.11.2019 Край: 01.09.2028 Възраст: от 18 г.

Canada, United States Alliance for Clinical Trials in Oncology NCT04114981

Активно (без набиране) Фаза 2

Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)

Solid Tumors

The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.

Начало: 18.11.2019 Край: 29.06.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +20 Merck Sharp & Dohme LLC NCT04123366

Активно (без набиране) Фаза 2

Daratumumab Combined With Bortezomib, Cyclophosphamide and Dexamethasone for the Treatment of Multiple Myeloma Patients Presenting With Extramedullary Disease

Multiple Myeloma Extramedullary Plasmacytoma

This trial will try to establish the feasibility and efficacy of the combination of DaraVCD in Multiple Myeloma (MM) patients presenting with extramedullary disease (EMD). The study will be conducted as a Phase II trial. Forty patients will be included in the study cohort. All patients will be followed closely for toxicities and response assessment. After completion of treatment, patients will be followed every 6 months for survival until 5 years after enrolment

Начало: 31.10.2019 Край: 01.03.2027 Възраст: от 18 г.

Greece, Italy, Turkey (Türkiye) Stichting European Myeloma Network NCT04166565

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An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant

Lung Transplant

The XVIVO Registry is to collect standard of care clinical data from "all-comers" who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device, and monitor device-related serious adverse events. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data.

Начало: 29.10.2019 Край: 24.04.2029 Възраст: от 18 г.

United States XVIVO Perfusion NCT05101460

Активно (без набиране) Ранна Фаза 1

Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide

Chronic Granulomatous Disease

Background: CGD causes infections and inflammation. The only cure currently is a bone marrow transplant. Most often a perfectly matched bone marrow donor is used. Researchers want to see if they can lower the risks of using a mismatched donor. Objectives: To see if it is safe to use a related bone marrow donor who is only a partial match to a person with CGD. To see how well drugs given to a person before and after transplant help the body accept the transplant. Eligibility: People ages 4-65 with CGD for whom stem cell transplant may be a cure and who do not have a perfectly matched donor, related or unrelated. Design: Participants will be screened with: Medical history Physical exam Blood tests Participants will be admitted to the hospital about 2 weeks before the transplant. They will have blood, urine, breathing, and heart tests. They may have CT and/or MRI scans. They will have a needle inserted into their hipbone to remove marrow. They will have dental, neurologic, and psychologic tests. They will have a central catheter placed: A line will be placed into a vein in their upper chest. They will get drugs, chemotherapy, and radiation to prepare for the transplant. Participants will receive the donated cells through their catheter. The cells will be from one of their relatives. Participants will stay in the hospital about 6 weeks after the transplant. After they leave the hospital, participants will have to stay in the area with visits about 2 times a week for approximately 100 days post transplant. Then visits will be every 3 to 6 months for 2 years. Then visits will be once a year....

Начало: 28.10.2019 Край: 15.06.2034 Възраст: 4–65 г.

United States National Institute of Allergy and Infectious Diseases ( NCT03910452

Активно (без набиране) Фаза 3

A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

Uveitis

The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.

Начало: 16.10.2019 Край: 01.07.2028 Възраст: 2–17 г.

France, Germany, Italy +2 Eli Lilly and Company NCT04088409

Активно (без набиране) Фаза 3

Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation

Preterm Premature Rupture of Membrane

The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.

Начало: 07.10.2019 Край: 01.11.2031 Възраст: от 18 г.

France Assistance Publique - Hôpitaux de Paris NCT03976063

Активно (без набиране)

Improving Brain Stimulation Through Imaging

Depression Depressive Disorder, Treatment-Resistant COVID Stress

Repetitive pulse transcranial magnetic stimulation (rTMS) is a noninvasive treatment that involves stimulating the brain; however, treatment benefit depends on placing a TMS coil in the correct place on the head to reach critical brain regions below. Clinicians typically use scalp-based targeting, a process in which rather than using MRI guidance to target brain regions for stimulation, they use landmarks on the scalp. Several researchers, including the investigators' lab, showed that the current scalp-based targeting techniques do not position stimulation above the correct brain region, and patients fail to respond. The investigators propose to improve clinical scalp-based targeting by comparing it to MRI guided targeting. The most common clinical population receiving rTMS therapy is depressed patients. The investigators' plan is to study the accuracy of certain scalp-based rules in patients with depression. Accurate brain stimulation targeting is critical for effective rTMS therapy. For participants who are not undergoing rTMS therapy who have COVID-19 distress, we are offering a combined home-based neuromodulation (transcranial electrical stimulation) and focused psychotherapy program dedicated to improving the same outcome measure, quality of life. Transcranial electrical stimulation (tES) stimulates the brain over a large region; however, we are able to model with brain imaging which brain regions receive the strongest stimulation. Our goal is still to examine stimulation precision, but we will test whether strength of tES in the same brain regions that rTMS is targeting will also lead to improved quality of life. We will also carefully assess whether it is possible to measure healthy functioning, an outcome in the rTMS study, because sheltering in place may reduce activities and thus distort our measure. We will also test whether our psychotherapy intervention will mitigate this effect and, if so, we may make it available to all those depressed Veterans in whom we're studying the effect of neuromodulation on functioning.

Начало: 30.09.2019 Край: 01.05.2026 Възраст: 18–89 г.

United States VA Office of Research and Development NCT03851380

Активно (без набиране) Фаза 3

Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease

Chagas Disease

This study evaluate the efficacy and safety of benznidazole in the treatment of chronic indeterminate Chagas disease in children. All subjects will receive benznidazole and results will be compared to historically to a placebo arm.

Начало: 19.09.2019 Край: 30.03.2028 Възраст: 2–18 г.

Argentina, Bolivia, Colombia Insud Pharma NCT04024163

Активно (без набиране) Фаза 3

Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury

Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury

The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.

Начало: 16.09.2019 Край: 01.04.2027 Възраст: 18–85 г.

Belgium, Canada, Czechia +12 Merz Pharmaceuticals GmbH NCT03992404

Активно (без набиране)

Fructose: Substrate, Stimulus, or Both?

Insulin Resistance Insulin Sensitivity Pre Diabetes

This objective of this study is to use sensitive methodology under controlled conditions to investigate the mechanisms by which fructose consumption contributes to excess fatty acid synthesis and elevations in blood glucose levels following consumption of meals containing fructose.

Начало: 15.09.2019 Край: 20.12.2026 Възраст: 20–55 г.

United States Touro University, California NCT04168372

Активно (без набиране) Фаза 3

An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Metastatic Hormone Sensitive Prostate Cancer

The purpose of this study was to evaluate the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in Chinese subjects with metastatic hormone sensitive prostate cancer (mHSPC). The study was conducted in two phases: Double-Blind treatment phase and open-label phase.

Начало: 11.09.2019 Край: 31.12.2028 Възраст: от 18 г.

China Astellas Pharma China, Inc. NCT04076059

Активно (без набиране) Ранна Фаза 1

Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma

Relapsed Hodgkin Lymphoma Refractory Hodgkin Lymphoma

LCCC1852-ATL is a prospective 2-arm study designed to determine if chimeric antigen receptor T (CAR-T) cells result in immunomodulation which can be subsequently exploited by programmed cell death protein 1 (PD-1) antibodies to achieve clinical responses in subjects with relapsed/refractory (r/r) classical Hodgkin Lymphoma (cHL).

Начало: 01.09.2019 Край: 07.07.2037 Възраст: от 18 г.

United States UNC Lineberger Comprehensive Cancer Center NCT04134325

Активно (без набиране) Фаза 3

Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer

Endometrial Clear Cell Adenocarcinoma Endometrial Dedifferentiated Carcinoma Endometrial Endometrioid Adenocarcinoma Endometrial Mixed Cell Adenocarcinoma +12

This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back after a period of improvement (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.

Начало: 22.08.2019 Край: 26.09.2026 Възраст: от 18 г.

Canada, Japan, Puerto Rico +2 National Cancer Institute (NCI) NCT03914612

Активно (без набиране) Фаза 2

Taxane and Taxane-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 +17

This phase II trial studies whether a prior germline predictor of taxane-induced peripheral neuropathy (TIPN) can help identify a subgroup of patients who are at higher risk of chemotherapy-induced peripheral neuropathy in African American patients with stages I-III breast cancer. The study also investigates whether docetaxel maybe work better than paclitaxel with regard to TIPN rate/severity and dose reductions.

Начало: 09.08.2019 Край: 31.03.2027 Възраст: от 18 г.

United States ECOG-ACRIN Cancer Research Group NCT04001829

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