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

A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination with Atezolizumab Compared with Atezolizumab as Maintenance Therapy in Participants with Extensive Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy with Carboplatin, Etoposide and Atezolizumab

Date Added
March 27th, 2023
PRO Number
Pro00118564
Researcher
Mariam Alexander

List of Studies

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

This study is for patients that have been diagnosed with extensive-stage small-cell lung cancer (ES-SCLC). The investigational drug in this study is lurbinectedin. Investigational means it is not yet approved by the Food and Drug Administration (FDA). The purpose of this study is to compare the effects, good or bad, of lurbinectedin in combination with atezolizumab versus atezolizumab alone in participants with ES-SCLC. Atezolizumab is already approved for treatment of ES-SCLC.

There are two phases of treatment. During the induction phase of the treatment, participants will receive 4 cycles of carboplatin, etoposide, and atezolizumab. One treatment cycle is 3 weeks long. During the maintenance phase of the treatment, participants will be placed in one of the following treatment groups: Arm A will receive atezolizumab and lurbinectedin given as an infusion (into the vein) on Day 1 of each 21-day cycle; Arm B will receive atezolizumab given as an infusion (into the vein) on Day 1 of each 21-day cycle.

During this study, participants will have visits approximately every 3 weeks while receiving treatment. Visits may last 3-6 hours. After the final dose, the study doctor will follow up about every 3 months. The total time in the study will depend on how the ES-SCLC responds to treatment. This could range from 1 day to more than 4 years.

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

Mental Fatigue and Self-Care in Informal Oncology Caregivers: A Descriptive Mixed Methods Study

Date Added
October 7th, 2022
PRO Number
Pro00122174
Researcher
Megan Wayne

List of Studies

Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Mental Health, Non-interventional
Summary

This study is for anyone 18 years or older who provides unpaid care for a loved one living with cancer outside of the hospital setting. The purpose of this study is to help future caregivers and patients by learning how mental fatigue affects caregivers of persons living with cancer and determine if mental fatigue, participating in self-care activities, and general caregiver quality of life are related. Informal caregivers will be invited to complete a confidential, online survey that takes between 25 and 35 minutes to finish. Caregivers who complete the survey may be contacted and asked to participate in a 45-60 minute follow up interview either online or via phone if they are interested. The results of this study will help guide future research to identify ways healthcare professionals can help caregivers handle the stresses of caregiving and provide the best care possible to their loved ones at home.

Institution
MUSC
Recruitment Contact
Megan Wayne
8433070366
wayneme@musc.edu

Neuroendocrine Tumors Patient Reported Outcomes (NET-PRO)

Date Added
August 23rd, 2022
PRO Number
Pro00120896
Researcher
William Lancaster

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Lung
Summary

The purpose of this research study is to gain patient feedback around their Neuroendocrine tumor (NET) diagnosis, including symptoms and quality of life with different NET treatments, factors that influence the order of treatments given, and how the order of NET treatments affect patient's quality of life, symptoms and survival. The main eligibility criteria for this study are being 18 or older and receiving the diagnosis of a neuroendocrine tumor on or after January 1st, 2019. Participation will last about 18 months, involving the completion of four electronic or paper surveys spaced six months apart. The first survey will take about 40 minutes to complete, while the other three surveys may take about 20 minutes each to complete. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Eryn Beal
(843) 792-7011
bealery@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

DNA EVALUATION OF FRAGMENTS FOR EARLY INTERCEPTION - LUNG CANCER TRAINING STUDY (DELFI-L101 STUDY)

Date Added
March 1st, 2022
PRO Number
Pro00116049
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

The purpose of this study is to collect blood samples to determine if a blood-based test can be used to identify lung cancers that may or may not also be seen on images of lungs. Additionally, the study aims to see if a blood-based test can identify other types of cancers and health conditions.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Unbiased Discovery and Validation of Serum Auto-Antibodies in Patients with Rheumatic Immune-Related Adverse Events Due to Immune Checkpoint Inhibitors

Date Added
January 18th, 2022
PRO Number
Pro00117791
Researcher
John Wrangle

List of Studies


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

This study is for subjects that have been diagnosed with cancer, as well as healthy research subjects. The purpose of this study is to evaluate the risk factors for development of immune related adverse side effects from cancer immunotherapy and to evaluate differences from healthy research subjects. Participation in the study will take about 2 visits over a period of 6 months.

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

A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination with AMG 404 in Subjects with Small Cell Lung Cancer (SCLC)

Date Added
January 11th, 2022
PRO Number
Pro00115977
Researcher
Mariam Alexander

List of Studies

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

This study is for patients who have been diagnosed with small cell lung cancer (SCLC). The investigational drug in the study is AMG 757. Both drugs are immunotherapy treatments, medicines that work with your immune system to help fight cancer. AMG 757 will be given in a liquid form directly into participants' veins (intravenously). This study is being done to find out about the safety and efficacy (effects good or bad) of AMG 757 for the treatment of SCLC. Participants can expect to receive treatment for about 24 months.
The duration of AMG 757 treatment will depend on how the disease responds to the investigational drugs and how the body tolerates AMG 757. So, participation may be longer or shorter than this window. The study period includes screening period lasting up to 21 days, a treatment period, a first safety follow-up visit, and a second safety follow-up visit. This will be followed by long-term follow-up visits up to 1 year from the first dose of AMG 757 for a total of about 3 years in the study.

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

A Phase 1/2 Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Patients with MET Overexpressing Advanced Cancer

Date Added
November 23rd, 2021
PRO Number
Pro00115889
Researcher
Mariam Alexander

List of Studies

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

This study is for patients who have been diagnosed with advanced non-small cell lung cancer (NSCLC) and have a certain protein, called MET in their tumor. The investigational drug in this study is REGN5093-M114 (study drug). The study drug works by bringing chemotherapy to the cells that express MET protein to kill those cells and not the other tissues in your body. The aim of the study is to see how safe, tolerable (how your body reacts to the drug), and effective the study drug is. Participants will receive the study drug intravenously (in your vein) every 3 weeks for as long as they tolerate the drug well and the cancer is stable or responding to the study drug. There is then 2 follow up visits 30 and 90 days after the last dose of study drug and telephone calls every 30 days until the study ends.

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



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