Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People

Date Added
February 22nd, 2021
PRO Number
Pro00105369
Researcher
Carla Danielson

List of Studies


Keywords
Adolescents, HIV / AIDS, Substance Use
Summary

Human subjects are being recruited for the proposed study to participate in usability testing for a virtual reality technology tool to be refined for assessment and prevention of risky sexual and substance use behaviors. Specifically, 15 adolescents, 15 young men, and 15 front line health care providers will participate in qualitative interviews and focus groups. Targeted enrollment is based on estimates from the existing clinical population treated by the local clinics from which participants will be recruited and the candidate's experience conducting clinical studies at these sites.

Institution
MUSC
Recruitment Contact
Nathalie Slick
843) 408-6140
slick@musc.edu

67Cu-SARTATE Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma: A Multi-center, Dose-escalation, Open-label, Non-randomized, Phase 1-2a Theranostic Clinical Trial

Date Added
February 9th, 2021
PRO Number
Pro00105726
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for participants that have been diagnosed with a high-risk neuroblastoma that cannot be treated or did not improve with existing therapies, or the cancer came back after treatment with existing therapies. This study involves investigational drugs called 64Cu-SARTATE and 67Cu-SARTATE. The investigational drugs will be given as an IV injection. The study is divided into 2 parts: The Dose Escalation Phase and the Cohort Expansion Phase. The phase that participants will enroll to will depend on when they enter the study. The age range for participants is from 12 months to 25 years. Participants can expect to be in this study for approximately 14 months. Then followed by remote or virtual visits every 6 months for up to 36 months (3 years) after the initial dose of study therapy drug 67Cu-SARTATE.

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

Clinical Trial of the Fit Families Multicomponent Obesity Intervention for African American Adolescents and Their Caregivers: Next Step from the ORBIT Initiative

Date Added
January 5th, 2021
PRO Number
Pro00106021
Researcher
Phillippe Cunningham

List of Studies


Keywords
Adolescents, Minorities, Obesity
Summary

The purpose of this study is to test the effectiveness of a comprehensive treatment for African-American adolescents with obesity and their overweight or obese caregiver (e.g., parent). Families who decide to participate in this study will be randomly assigned to one of two intervention groups: the FIT Families group or the Home-Based Family Support (HBFS) group. This means participants have a 50/50 chance (like flipping a coin) of being in either group. Participants randomized to FIT Families will have sessions with a community health worker (CHW) in the home or community once or twice weekly based on the family's preference for the first three months, and weekly for the second three months. Some of the sessions might occur virtually (online) if needed. Participants randomized to HBFS will receive six months of weekly family counseling in their home or community with a community health worker (CHW). Some of these sessions might occur virtually (online) if needed. Participants in both groups will receive education and support for healthier lifestyles.
The study will last 18 months. During the 18-month study period, youth and caregivers will wear a FitBit activity tracker during the six months of the intervention and then for 2 weeks at the fourth assessment, complete study assessments, have their height, weight, and blood pressure measured, and provide finger prick blood samples to be tested for blood sugar and cholesterol levels.
Potential benefits to caregivers and youth who participate in the study include: positive changes in healthy lifestyle behaviors and weight loss, decrease in health risks associated with obesity, and improved family relations, though these cannot be guaranteed.

Institution
MUSC
Recruitment Contact
Elizabeth O'Brien
843-876-0219
obriene@musc.edu

A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Date Added
December 22nd, 2020
PRO Number
Pro00106138
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have newly diagnosed High-Risk B-ALL, Risk-Adapted Post-Induction therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy. The treatment involves medicine called chemotherapy, which fights cancer. Some patients may also need radiation therapy depending on whether the cancer has spread to the brain and spinal fluid, or the testes for males. The investigational drug on this study is inotuzumab ozogamicin. Participants can expect to be on this study for a little over 2 years and followed for up to 10 years.

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

Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Date Added
November 19th, 2020
PRO Number
Pro00105634
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT). The treatment involves cancer fighting medicine called chemotherapy plus radiation therapy and/or surgery. Participants can expect to be on this study for up to 10 months and be followed by the treatment team for up to 5 years.

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

Targeting Parenting to Prevent HIV and Substance Use Among Trauma-Exposed Youth: A Mixed-Methods Needs Assessment

Date Added
March 16th, 2020
PRO Number
Pro00096161
Researcher
Nada Goodrum

List of Studies

Keywords
Adolescents, Alcohol, HIV / AIDS, Mental Health, Psychiatry, Sexually Transmitted Infections (STI), Substance Use
Summary

Many adolescents experience traumatic events, such as child abuse, physical or sexual assault, or witnessing violence. Teens who experience trauma are more likely to have problems with substance use and risky sexual activity. We want to understand how parents can support their teens and help keep them safe after traumatic events.

Institution
MUSC
Recruitment Contact
Nada Goodrum
843-792-8067
goodrumn@musc.edu

Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or Durvalumab in Combination with Tremelimumab in Pediatric Patients with Advanced Solid Tumors and Hematological Malignancies

Date Added
July 9th, 2019
PRO Number
Pro00087746
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for pediatric patients that have been diagnosed with advanced solid tumors and hematological malignancies that have stopped responding to standard therapy. The investigational drugs in this study are durvalumab and tremelimumab. The purpose of this research study to find out if the study drugs called durvalumab and tremelimumab will work and be safe for the treatment of advanced cancer in children. Participants can expect to be on this study for up to 6 years.

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

A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Germ Cell Tumors

Date Added
July 3rd, 2019
PRO Number
Pro00089975
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed metastatic germ cell tumors. This study will compare the standard chemotherapy regimen with an accelerated chemotherapy regimen using the same drugs to see if the accelerated chemotherapy regimen is beneficial but not more toxic than the standard chemotherapy regimen. The accelerated chemotherapy is experimental. Participants can expect to be on study for about 3 months and continue to be followed for up to 5 years.

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

Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)

Date Added
May 15th, 2019
PRO Number
Pro00081406
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Epstein-Barr Virus associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD). The investigational drug in this study is tabelecleucel. Tabelecleucel is a product containing special immune allogeneic cells, called EBV-Cytotoxic T Lymphocytes (EBV-CTLs), that are made in the laboratory starting with cells from a healthy person who is immune to EBV. The purpose of this study is to test how well tabelecleucel works to treat EBV-PTLD following SOT in patients who have not responded to rituximab or rituximab plus chemotherapy treatment and to see what side effects happen. Your participation will help us to understand more about tabelecleucel. In the first 12-month period, participants will be asked to come to the clinic for an estimated 11 to 19 study visits and a minimum of 2 scans, depending on the number of cycles of treatment they are given. After treatment is done, participants will enter into the follow-up phase, and will continue to come into the clinic for scheduled check-ups for up to 24 months after the first dose of tabelecleucel was given. Participant information on the status of their disease and any new treatment will be collected for up to an additional 3 years. Participants can expect to be in this study for up to five years total.

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



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