metaGENomic Sequencing to detect Infections in SOTR (Solid Organ Transplant Recipients): The mGENeSIS Registry

Date Added
April 22nd, 2025
PRO Number
Pro00143016
Researcher
Drew Charles

List of Studies

Keywords
Transplant
Summary

Examine current real-world utilization of mcfDNA using a multi-center retrospective registry. To achieve this aim, we will utilize a multi-center REDCap database to examine and summarize patient demographics and types of transplants where mcfDNA was used. We will classify cases based on common syndromes/indications for which mcfDNA is sent, timing of the test, and clinically relevant microbiologic yield of mcfDNA results.

Identify clinical predictors where mcfDNA outperforms CMT. We will analyze specific clinical syndromes where mcfDNA has higher yield compared to CMT including pneumonia, visceral abscesses, CNS infections, etc. We will also
identify specific pathogens that are more likely to be detected by mcfDNA earlier in the clinical course such as bartonella, syphilis, parasitic infections, and other atypical bacteria, mycobacteria, and fungi.

Analyze clinical impact of mcfDNA to assess whether the use of the test had a positive vs. negative vs. neutral impact on patient care using pre-specified definitions. Additionally, we will perform clinical adjudication of positive and
negative mcfDNA cases using standardized criteria and analyze effect of timing of test ordering on clinical impact.

Institution
MUSC
Recruitment Contact
Drew Charles
8437924549
charlesd@musc.edu

A Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care (Neurorrhaphy) in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair

Date Added
August 27th, 2025
PRO Number
Pro00145325
Researcher
Charles Daly

List of Studies

Keywords
Nerve, Surgery
Summary

The study is a 48-week clinical study to compare study medication NTX-001 used intraoperatively to promote nerve regeneration compared to the standard of care on surgery for acute nerve damage in the hand on subjects between the ages of 18 to 80 years old. Subjects who present with sever nerve damage of the hand and need surgery to repair the nerve damage within 48 hours of injury. After surgery, subjects will complete 12 total study visits: 6 in person and 6 additional telehealth visits. During the in-person clinic visits, subjects will be assessed by physical examinations, vital signs, safety laboratory assessment and complete questionnaires. Subjects with motor/mixed motor injury will also complete an EMG and NCV assessments with an Occupational Therapist at 2 of the in-person visits. During the telehealth visits, subjects will complete questionnaires.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu

A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non–Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

Date Added
July 15th, 2026
PRO Number
Pro00150765
Researcher
William Charles

List of Studies

Keywords
Cancer/Lung
Summary

This study is looking for patients who have been diagnosed with advanced non–small cell lung cancer (NSCLC) that have certain biomarkers (negative for PD-L1, and positive for KRAS p.G12C). This study is being conducted to determine how well participants respond to treatment with chemotherapy (carboplatin and pemetrexed) combined with either sotorasib or pembrolizumab. The study will determine whether sotorasib and chemotherapy reduces the risk of this type of cancer getting worse and improves participants survival (i.e., increases the chance of you living longer) compared to the current standard treatment with pembrolizumab and chemotherapy. It is anticipated that participants will be enrolled in this study for approximately 5 and a half years. There will be a total of approximately 15 visits to the study site during the study depending on how well participants tolerate or respond to the study drug. The visits will take several hours each and will take place approximately every 3 weeks.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Amanda Balasco
803-313-3202
balasco@musc.edu



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