An Observational Cohort Study to Determine Late Outcomes and Immunological Responses after Infection with SARS- CoV-2 in Children with and without Multisystem Inflammatory Syndrome (MIS-C)

Date Added
October 6th, 2020
PRO Number
Pro00104091
Researcher
Natasha Ruth

List of Studies


Keywords
Coronavirus, Pediatrics
Summary

We will aim to enroll children who have had a nasal swab test showing infection with SARS-CoV-2, the virus that causes COVID-19, or children with a serious complication of COVID-19 called the Multi-system Inflammatory Syndrome in Children (MIS-C). This study does not offer any treatment for COVID-19 or MIS-C. The purpose of the study is to collect information that will help us understand what happens to children and young adults who get infected with SARS-CoV-2, and how their immune system responds. Most of the information that we will collect is part of usual care for young people who have COVID-19 or MIS-C. In addition, we will do some extra clinical and blood tests. Children and young adults who are enrolled in the study will be followed for one year. Our goal is to enroll up to 250 children and young adults (up to the time of your 21st birthday) from about 20 hospitals in the United States. At our center we plan to enroll about 10 participants.

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-876-8692
panacceb@musc.edu

Long-TerM OUtcomes after the Multisystem Inflammatory Syndrome In Children: MUSIC

Date Added
September 30th, 2020
PRO Number
Pro00103636
Researcher
Kimberly McHugh

List of Studies


Keywords
Coronavirus, Pediatrics
Summary

This observational study will determine the spectrum and time course of coronary artery involvement, left ventricular (LV) systolic function, and arrhythmias or conduction system disturbances within the first year from illness onset, and to define associated clinical and laboratory factors in a cohort of MIS-C affected patients.

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-876-8692
panacceb@musc.edu

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

Date Added
September 25th, 2020
PRO Number
Pro00104024
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Acute Myelogenous Leukemia (AML). This study will compare standard chemotherapy using daunorubicin, cytarabine and gemtuzumab ozogamicin (GO) to chemotherapy using an experimental drug called CPX-351. CPX-351 is made up of daunorubicin and cytarabine. CPX-351 is made in a way that makes the drugs stay in the bone marrow longer and may be more effective. CPX-351 has been shown to be well-tolerated and effective against leukemia in adults and children. Participants can expect to receive treatment on this study for 6 months and followed for up to 10 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
HCC Clinical Trials Office843-792-9321
hcc-clinical-trials@musc.edu

Influenza Vaccine Effectiveness for Preventing Laboratory-Confirmed Severe Influenza-Associated Illness and Understanding Coronavirus Disease 2019 (Overcoming COVID-19) in US Children

Date Added
September 17th, 2020
PRO Number
Pro00102181
Researcher
Elizabeth Mack

List of Studies


Keywords
Coronavirus, Pediatrics
Summary

The Overcoming Cohort study is a studies looking for variations in DNA,for populations less than or 25 years of age, that either protect people from COVID-19 disease or make them more susceptible. The study will sequence patients' entire genome or the smaller group of genes that code for proteins (exome). The study would gain a better understanding of COVID-19 that would improve diagnostic, prevention, and treatment measures.

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-876-8692
panacceb@musc.edu

Prospective Non-Interventional Study in Patients with Locally Advanced or Metastatic TRK Fusion Cancer Treated with Larotrectinib

Date Added
September 17th, 2020
PRO Number
Pro00090298
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This is an observational study, which means that only information is collected on treatment, examinations or diagnostic tests which are a part of the routine standard of care. The participant is being asked to volunteer because they have been diagnosed with locally advanced or metastatic TRK fusion cancer treated with larotrectinib. The purpose of this study is to learn more about the safety profile and the effectiveness of VITRAKVI® under routine practice conditions.
Participants will be followed for a minimum of 5 years from the time they agree to participate in the study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)

Date Added
September 2nd, 2020
PRO Number
Pro00102404
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Brain, Cancer, Pediatrics
Summary

This study is for patients that have been newly diagnosed with BRAF v600-Mutant High-Grade Glioma (HGG). The overall goal of this study is to see if using two drugs called dabrafenib and trametinib after radiation treatment will be better than treatments used in the past in helping to get rid of or shrink HGG. The treatment involves cancer fighting medicines plus radiation. The treatment on this study takes a little over 2 years. It is divided into 2 phases of therapy.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase II Study of Metronomic and Targeted Anti-Angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma

Date Added
September 1st, 2020
PRO Number
Pro00091939
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Brain, Brain Tumor, Cancer, Central Nervous System, Children's Health, Drug Studies, Pediatrics, Spinal Cord
Summary

This study is for patients with recurrent/progressive medulloblastoma, which is a type of childhood brain tumor. Participants in this study will receive intravenous (IV, into the veins) bevacizumab and intrathecal (into the spinal fluid) or intraventricular (into the fluid surrounding the brain) etoposide and cytarabine in combination with five oral (taken by mouth) chemotherapy drugs as a possible treatment for recurrent/progressive medulloblastoma. Total study duration is about 1 year and depending on how well a participant tolerates the medications and the response of the disease, the patient may continue the treatment after the first year.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trails@musc.edu

A Randomized, Parallel-arm, Active Control, Multicenter Study Assessing the Safety and Efficacy of Dextenza for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

Date Added
August 25th, 2020
PRO Number
Pro00100918
Researcher
Marion Wilson

List of Studies


Keywords
Pediatrics, Vision/ Eye
Summary

Many children experience signs and/or symptoms of inflammation after cataract surgery. If left untreated, inflammation generally resolves within 2 to 4 weeks after surgery; however, inflammation can lead to complications without treatment. Doctors commonly use drugs, called corticosteroids, that are like the study product to reduce inflammation and the pain and discomfort it causes following cataract surgery. The purpose of this study is to compare the effects of DEXTENZA® to a drug already on the market (prednisolone acetate suspension) in treating the inflammation in the eye after cataract surgery. DEXTENZA® is an insertion and prednisolone acetate suspension is delivered as an eye drop. It is believed that DEXTENZA® may provide potential benefits because it requires only a single application by the physician at the time of cataract surgery. Eye drops are typically applied several times a day for several weeks.

Institution
MUSC
Recruitment Contact
Carol Bradham
8437926301
bradhamc@musc.edu

Expanded Access to Convalescent Plasma for the Treatment of Pediatric Patients with COVID-19

Date Added
August 4th, 2020
PRO Number
Pro00102411
Researcher
Andrew Atz

List of Studies


Keywords
Coronavirus, Pediatrics
Summary

People who recover from COVID-19 do so, at least in part, because their blood contains substances called antibodies, which are capable of fighting the virus that causes the illness. It turns out that for some other diseases caused by respiratory viruses, giving people the liquid portion of blood, called plasma, obtained from those who have recovered from the virus, leads to more rapid improvement of the disease. We think that patients with COVID-19 may improve faster if they receive plasma from those who have recovered from COVID-19, because it may have the ability to fight the virus that causes COVID-19.
We are performing this study to see if children admitted to the hospital with COVID-19 may have an improved chance of recovery by receiving plasma from someone who has recovered from COVID-19.

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-876-8692
panacceb@musc.edu

Intermediate-size Expanded Access of Remestemcel-L, Human Mesenchymal Stromal Cells, for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with Coronavirus Disease (COVID-19)

Date Added
July 28th, 2020
PRO Number
Pro00102047
Researcher
Allison Eckard

List of Studies


Keywords
Coronavirus, Pediatrics
Summary

Remestemcel-L will be evaluated in children or adolescents with multisystem inflammatory syndrome (MIS-C) associated with coronavirus disease (COVID-19) who have baseline myocardial complications. The primary objective of this study is to assess the safety and tolerability of remestemcel-L in Multisystem Inflammatory Syndrome in Children (MIS-C) associated with coronavirus disease (COVID-19).

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-876-8692
panacceb@musc.edu



-- OR --