Southeastern Consortium for Lung Cancer Health Equity (SC3) Biospecimen Repository

Date Added
May 8th, 2023
PRO Number
Pro00128239
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is designed to collect saliva and blood samples from subjects going through the Lung Cancer Screening Program to compare biomarker test results to develop lung cancer clinical risk prediction models further. Also, this study will store blood samples in a biorepository.

Institution
MUSC Health Chester Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Southeastern Consortium for Lung Cancer Health Equity (SC3) Biospecimen Repository

Date Added
May 8th, 2023
PRO Number
Pro00128239
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is designed to collect saliva and blood samples from subjects going through the Lung Cancer Screening Program to compare biomarker test results to develop lung cancer clinical risk prediction models further. Also, this study will store blood samples in a biorepository.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Southeastern Consortium for Lung Cancer Health Equity (SC3) Biospecimen Repository

Date Added
May 8th, 2023
PRO Number
Pro00128239
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is designed to collect saliva and blood samples from subjects going through the Lung Cancer Screening Program to compare biomarker test results to develop lung cancer clinical risk prediction models further. Also, this study will store blood samples in a biorepository.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Southeastern Consortium for Lung Cancer Health Equity (SC3) Biospecimen Repository

Date Added
May 8th, 2023
PRO Number
Pro00128239
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is designed to collect saliva and blood samples from subjects going through the Lung Cancer Screening Program to compare biomarker test results to develop lung cancer clinical risk prediction models further. Also, this study will store blood samples in a biorepository.

Institution
MUSC Health Kershaw Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Southeastern Consortium for Lung Cancer Health Equity (SC3) Biospecimen Repository

Date Added
May 8th, 2023
PRO Number
Pro00128239
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is designed to collect saliva and blood samples from subjects going through the Lung Cancer Screening Program to compare biomarker test results to develop lung cancer clinical risk prediction models further. Also, this study will store blood samples in a biorepository.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancer

Date Added
April 25th, 2023
PRO Number
Pro00127146
Researcher
Ian Bostock Rosenzweig

List of Studies

Keywords
Cancer/Lung, Lung, Men's Health, Women's Health
Summary

This collaborative study was developed by the Lung Cancer Mutation Consortium (LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG). The purpose of this study is to determine if it is possible to identify genetic changes in the tumors or blood of patients with early-stage lung cancers using both blood-based and tumor-based testing when cancer is suspected or first diagnosed. In this trial, participants will be asked to provide blood samples at three different time points. They will also be asked for permission for tumor tissue to be sent to the researchers. Tumor tissue will be collected if there is a leftover sample from a participant's surgery. These samples will be sent to the researchers to be analyzed for genetic changes. The researchers hope that in the future, genetic changes can help doctors determine what the best treatment is for patients with early-stage lung cancer.

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

Spirometry, Education, and Action Plans (SEAS) for COPD Management in Rural South Carolina

Date Added
April 11th, 2023
PRO Number
Pro00127202
Researcher
Sarah Miller

List of Studies


Keywords
COPD, Lung
Summary

The purpose of this study to test a smartphone app with a breathing device that aims to help patients monitor and manage their COPD and improve their quality of life. This device measures how well the lungs are working, like a lung function test. This study lasts for 6 months and study procedures can be conducted remotely with no required study clinic visits. Eligible participants will be given a breathing device called a remote spirometer and will be asked to download an app to their phone and use the device to monitor their lung function and symptoms. A total of 120 individuals with COPD who live in rural areas of SC will be enrolled in this study.

Institution
MUSC
Recruitment Contact
Sarah Miller
843-792-1692
millesar@musc.edu

A Phase 3, Open-label, Randomized Study of Lazertinib with Subcutaneous Amivantamab Administered via Manual Injection Compared with Intravenous Amivantamab or Amivantamab Subcutaneous On Body Delivery System in Patients with EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

Date Added
February 27th, 2023
PRO Number
Pro00124906
Researcher
Mariam Alexander

List of Studies

Keywords
Lung
Summary

This is a 2 Part, Phase 3, open-label, randomized study to sequentially demonstrate the pharmacokinetic noninferiority of amivantamab SC-CF administered via manual injection compared with amivantamab IV (Part 1) and the bioequivalence of amivantamab SC-CF administered via a manual injection versus amivantamab subcutaneous, co-formulated with recombinant human hyaluronidase, and delivered with an on-body delivery system (SC-CF OBDS; Part 2). The combination product of the device (on-body delivery system; OBDS) plus the study drug amivantamab SC-CF (hereafter referred to as amivantamab SC-CF OBDS) is provided as a completely assembled, ready to use, single-use product. It is preloaded with a prefilled liquid drug product vial, thereby eliminating the need for drug preparation by a pharmacist. The formulation of amivantamab SC-CF used in amivantamab SC-CF OBDS is identical to the manual injection formulation of amivantamab SC-CF (but differs from the IV formulation).

Lazertinib (JNJ-73841937) is an oral, highly potent, third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) with no demonstrated pharmacokinetic (PK) interaction with amivantamab. It selectively inhibits both activating EGFR mutations (Exon 19del, L858R) and the EGFR T790M resistance mutation
while showing mutant-selective activity for EGFR.

The primary objectives are to assess the pharmacokinetic noninferiority of amivantamab SC-CF via manual injection versus amivantamab IV (Part 1) and to assess the bioequivalence of amivantamab SC-CF via manual injection and amivantamab SC-CF OBDS (Part 2). Key secondary objectives are to assess efficacy (objective response rate [ORR] and progression-free survival [PFS]) and safety of the different administrations.

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

PEERLESS Study

Date Added
September 13th, 2022
PRO Number
Pro00121998
Researcher
Thomas Todoran

List of Studies


Keywords
Blood Disorders, Lung
Summary

This study is for participants who have been diagnosed with a pulmonary embolism or PE. A PE is a blood clot in the lung. This study is comparing the FlowTriever Retrieval/Aspiration System to any commercially available Catheter Directed Thrombolysis system in participants who have a PE and undergo a procedure to remove the clot. Participants will be randomized which means they will be randomly assigned like the flip of a coin to have the procedure done wit the the FlowTriever system or a CDT system. All of the devices being used in this study are FDA approved for this indication. This study involves collecting data from the time of diagnosis through 30 days post procedure. Study participation will last about 30 days.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843.792.2944
adamsde@musc.edu

A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

Date Added
August 2nd, 2022
PRO Number
Pro00121443
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed with advanced non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using SBRT plus the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the addition of SBRT increases the life of patients by 6 months or more compared to the usual approach. The study drugs are nivolumab and ipilimumab. Participants can expect to be on this study for up to 2 years.

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



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