Quantitative Neuroimaging Assessment of White Matter Integrity in the Context of Aging and AD

Date Added
December 19th, 2017
PRO Number
Pro00073604
Researcher
Andreana Benitez

List of Studies


Keywords
Aging, Alzheimers, Brain, Healthy Volunteer Studies
Summary

The purpose of this study is to use neuroimaging to understand how networks in the brain change over time. Although the single most significant risk factor for developing Alzheimer's disease (AD) is age, the neurobiological processes underlying the transition from normal aging to AD are not well understood. Our group of researchers has developed ways to use MRI to detect small changes in certain parts of the brain. We will use neuroimaging to understand how the connections in the brain change over time in healthy aging. The goal is to discover which brain changes are present in healthy aging.

Participants will have two study visits (about 2 years apart) where they will undergo tests to assess mental function, fill out questionnaires, and undergo a blood draw, brain MRI and PET scan and provide a saliva sample. At the second visit, participants will not repeat PET scan. Participants will continue to be followed longitudinally every two years as long as the study is funded.

Participants are required to have a Co-Participant accompany them for the first portion of each visit. This individual must be a reliable informant that has contact with the participant at least once per week.

Institution
MUSC
Recruitment Contact
Katrina Madden
843-792-9186
IAMstudy@musc.edu

Expanded Access Protocol (EAP) for Subjects Receiving Lisocabtagene Maraleucel That is Nonconforming for Commercial Release

Date Added
May 11th, 2021
PRO Number
Pro00107699
Researcher
Brian Hess

List of Studies


Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with relapsed (came back) and/or refractory (not responding to treatment) large B-cell lymphoma (LBCL). The investigational product is Lisocabtagene Maraleucel and is administered by infusion. Participants will have had the blood collection (leukapheresis - a laboratory procedure where white blood cells are separated from a sample of blood) procedure, where the T cells (white blood cells) were collected and genetically modified in a laboratory in order to manufacture the lisocabtagene maraleucel T cells for disease treatment. The lisocabtagene maraleucel T cells that were produced do not meet all of the prespecified release criteria to be used as a routine prescription drug as required by the Food and Drug Administration (FDA). This is called a nonconforming lisocabtagene maraleucel. The purpose of this study is to allow participants to be treated with their nonconforming lisocabtagene maraleucel. Participants can expect to be on the study for up to 3 months following the infusion of nonconforming lisocabtagene maraleucel.

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

B cells and Plasma Cells in Black Female Patients with SLE. Mechanistic Basis of Disease Heterogeneity.

Date Added
October 25th, 2021
PRO Number
Pro00114306
Researcher
Gary Gilkeson

List of Studies


Keywords
Healthy Volunteer Studies, Lupus
Summary

The goal of this study is to determine the differences in severity and disparities of lupus in Black lupus patients, focusing on the highest risk group, Black females. We are interested in enrolling Black females with lupus as well as smaller numbers of White females with lupus, White females as Healthy Controls and Black males with lupus.

Study participation involves the collection of 4 tablespoons of blood. Patients with lupus will have their study participation during a standard of care (SOC) visit with their rheumatologist as part having routine blood drawn for their lupus care. After the initial study visit, patients with lupus may have an additional 2-3 visits. Controls will have a single study visit at the MUSC Nexus clinical research center.

This is not a clinical trial and does not involve study medications. Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Andrea Semler
843-789-6798
semleraj@musc.edu

Molecular Assessment and Profiling of Liver transplant rEcipients: The MAPLE Study

Date Added
December 23rd, 2021
PRO Number
Pro00115748
Researcher
Jared White

List of Studies


Keywords
Liver, Transplant
Summary

The primary purpose of this registry is to evaluate the feasibility and clinical validation of LiverCare in liver transplant recipients, as part of post-transplant surveillance. LiverCare is an investigational panel test that includes 6 components: 1. AlloSure Liver 2. AlloMap Liver 3. AlloHeme Liver 4. iBox Liver 5. HistoMap Liver 6. AlloID. AlloSure Liver is a research test used to measure donor-derived cell free DNA in Liver transplant recipients. AlloMap Liver is a research gene expression profile test using peripheral blood to establish immune activity and is currently undergoing clinical evaluation and development. iBox Liver is an analytic platform that predicts organ outcomes after transplant using a software algorithm based on information from your medical records and is currently undergoing clinical evaluation and development. AlloHeme Liver is a diagnostic test to measure donor and recipient DNA in the blood. HistoMap Liver is a tissue-based gene expression test using tissue collected from standard of care biopsies to establish immune profiles within the organ and is currently undergoing clinical evaluation and development. AlloID is a blood test that will quantify the presence of more than 100 pathogens including standard post-transplant infectious disease screening such as Cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus, Human Herpesvirus 6 (HHV-6) and viral hepatitis.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

Molecular Assessment and Profiling of Liver transplant rEcipients: The MAPLE Study

Date Added
December 23rd, 2021
PRO Number
Pro00115748
Researcher
Jared White

List of Studies


Keywords
Liver, Transplant
Summary

The primary purpose of this registry is to evaluate the feasibility and clinical validation of LiverCare in liver transplant recipients, as part of post-transplant surveillance. LiverCare is an investigational panel test that includes 6 components: 1. AlloSure Liver 2. AlloMap Liver 3. AlloHeme Liver 4. iBox Liver 5. HistoMap Liver 6. AlloID. AlloSure Liver is a research test used to measure donor-derived cell free DNA in Liver transplant recipients. AlloMap Liver is a research gene expression profile test using peripheral blood to establish immune activity and is currently undergoing clinical evaluation and development. iBox Liver is an analytic platform that predicts organ outcomes after transplant using a software algorithm based on information from your medical records and is currently undergoing clinical evaluation and development. AlloHeme Liver is a diagnostic test to measure donor and recipient DNA in the blood. HistoMap Liver is a tissue-based gene expression test using tissue collected from standard of care biopsies to establish immune profiles within the organ and is currently undergoing clinical evaluation and development. AlloID is a blood test that will quantify the presence of more than 100 pathogens including standard post-transplant infectious disease screening such as Cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus, Human Herpesvirus 6 (HHV-6) and viral hepatitis.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

Molecular Assessment and Profiling of Liver transplant rEcipients: The MAPLE Study

Date Added
December 23rd, 2021
PRO Number
Pro00115748
Researcher
Jared White

List of Studies


Keywords
Liver, Transplant
Summary

The primary purpose of this registry is to evaluate the feasibility and clinical validation of LiverCare in liver transplant recipients, as part of post-transplant surveillance. LiverCare is an investigational panel test that includes 6 components: 1. AlloSure Liver 2. AlloMap Liver 3. AlloHeme Liver 4. iBox Liver 5. HistoMap Liver 6. AlloID. AlloSure Liver is a research test used to measure donor-derived cell free DNA in Liver transplant recipients. AlloMap Liver is a research gene expression profile test using peripheral blood to establish immune activity and is currently undergoing clinical evaluation and development. iBox Liver is an analytic platform that predicts organ outcomes after transplant using a software algorithm based on information from your medical records and is currently undergoing clinical evaluation and development. AlloHeme Liver is a diagnostic test to measure donor and recipient DNA in the blood. HistoMap Liver is a tissue-based gene expression test using tissue collected from standard of care biopsies to establish immune profiles within the organ and is currently undergoing clinical evaluation and development. AlloID is a blood test that will quantify the presence of more than 100 pathogens including standard post-transplant infectious disease screening such as Cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus, Human Herpesvirus 6 (HHV-6) and viral hepatitis.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

Molecular Assessment and Profiling of Liver transplant rEcipients: The MAPLE Study

Date Added
December 23rd, 2021
PRO Number
Pro00115748
Researcher
Jared White

List of Studies


Keywords
Liver, Transplant
Summary

The primary purpose of this registry is to evaluate the feasibility and clinical validation of LiverCare in liver transplant recipients, as part of post-transplant surveillance. LiverCare is an investigational panel test that includes 6 components: 1. AlloSure Liver 2. AlloMap Liver 3. AlloHeme Liver 4. iBox Liver 5. HistoMap Liver 6. AlloID. AlloSure Liver is a research test used to measure donor-derived cell free DNA in Liver transplant recipients. AlloMap Liver is a research gene expression profile test using peripheral blood to establish immune activity and is currently undergoing clinical evaluation and development. iBox Liver is an analytic platform that predicts organ outcomes after transplant using a software algorithm based on information from your medical records and is currently undergoing clinical evaluation and development. AlloHeme Liver is a diagnostic test to measure donor and recipient DNA in the blood. HistoMap Liver is a tissue-based gene expression test using tissue collected from standard of care biopsies to establish immune profiles within the organ and is currently undergoing clinical evaluation and development. AlloID is a blood test that will quantify the presence of more than 100 pathogens including standard post-transplant infectious disease screening such as Cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus, Human Herpesvirus 6 (HHV-6) and viral hepatitis.

Institution
MUSC Health Marion Medical Center
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

Molecular Assessment and Profiling of Liver transplant rEcipients: The MAPLE Study

Date Added
December 23rd, 2021
PRO Number
Pro00115748
Researcher
Jared White

List of Studies


Keywords
Liver, Transplant
Summary

The primary purpose of this registry is to evaluate the feasibility and clinical validation of LiverCare in liver transplant recipients, as part of post-transplant surveillance. LiverCare is an investigational panel test that includes 6 components: 1. AlloSure Liver 2. AlloMap Liver 3. AlloHeme Liver 4. iBox Liver 5. HistoMap Liver 6. AlloID. AlloSure Liver is a research test used to measure donor-derived cell free DNA in Liver transplant recipients. AlloMap Liver is a research gene expression profile test using peripheral blood to establish immune activity and is currently undergoing clinical evaluation and development. iBox Liver is an analytic platform that predicts organ outcomes after transplant using a software algorithm based on information from your medical records and is currently undergoing clinical evaluation and development. AlloHeme Liver is a diagnostic test to measure donor and recipient DNA in the blood. HistoMap Liver is a tissue-based gene expression test using tissue collected from standard of care biopsies to establish immune profiles within the organ and is currently undergoing clinical evaluation and development. AlloID is a blood test that will quantify the presence of more than 100 pathogens including standard post-transplant infectious disease screening such as Cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus, Human Herpesvirus 6 (HHV-6) and viral hepatitis.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

The role of estrogen receptor alpha variant size and localization in modulating TLR7-induced inflammation.

Date Added
January 21st, 2022
PRO Number
Pro00113082
Researcher
Melissa Cunningham

List of Studies


Keywords
Autoimmune disease, Healthy Volunteer Studies, Lupus
Summary

This observational, non-medication study's purpose is to help learn more about the immune system's inflammation process involved in lupus. The study will be enrolling both lupus and non-lupus (healthy control) females aged 18 and older who identify as Black/African American and Non-Hispanic or White and Non-Hispanic for this comparison study. Participation involves a one-time blood collection.

There are no direct benefits in participating, but it is hoped information learned may help us to develop a better understanding of lupus. Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Katlin Thompson
843-792-5290
kat238@musc.edu

Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Date Added
May 2nd, 2023
PRO Number
Pro00125254
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for patients that have been diagnosed with relapsed/refractory neuroblastoma. The investigational drug given is eflornithine (DFMO) along with etoposide. DFMO is the investigational drug being used along with etoposide for treatment of neuroblastoma. Participants will undergo a number of standard tests and research-related procedures before being able to enroll in this study. Some risks include but are not limited to: fewer red and white blood cells, diarrhea, abdominal pain, loss of appetite, skin rash, seizure, difficulty swallowing and blurred vision. Participants can expect to be on this study for approximately 2 years. Participants will then be followed for up to 5 years after study completion.

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



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