A Study to Evaluate a Panel of Blood Biomarkers for Use in Patients Undergoing Evaluation for Lung Cancer, ONC-LN-04 Save

Date Added
June 5th, 2017
PRO Number
Pro00061266
Researcher
Gerard Silvestri

Silhouette
Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The primary objective of this study is to develop a blood-based gene expression signature, known as the ONC-LN-04 Lung Test, to be used in the detection of lung cancer in patients who underwent radiologic screening for lung cancer and had lung nodules detected. We intend to enroll volunteers who are being evaluated by a Medical University of South Carolina (MUSC) pulmonologist as part of their standard medical care. Participants will be current or former smokers, who have either (a) radiologic evidence of lung nodules, or (b) a confirmed diagnosis of non-small cell lung cancer (NSCLC) and has not undergone surgical excision, chemotherapy or radiation therapy for this malignancy. A single blood sample will be obtained from willing participants, then stored and analyzed for measurement of gene expression and development of the ONC-LN-04 test. Active participation in this study will be over once a blood sample is obtained; however, we may need access to participants' medical records post-enrollment and sample collection in order to monitor medical outcomes. Review of participants' medical records will occur until up to approximately 2,500 subjects have been enrolled and have provided clinical information and a blood sample.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

Blood Sample Collection in Subjects Participating in a Lung Cancer Screening Program Save

Date Added
May 1st, 2017
PRO Number
Pro00064511
Researcher
Gerard Silvestri

Silhouette
Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The main objective of this study is to better understand the biomarkers of patients who are candidates for lung cancer screening. Biomarkers are biologic substances found in the blood and may be related to lung disease risk and detection. We intend to enroll volunteers who are participating in a lung cancer screening program at the Medical University of South Carolina and are being seen by a pulmonologist as part of their standard medical care. A single blood sample will be obtained, then stored and analyzed to better understand the biomarkers found in blood and to help develop and test blood based screening or diagnostic tests. Active participation in this study will be over once a blood sample is obtained. However, we may conduct medical chart reviews of some participants for up to 27 months in order to look at their medical outcomes.

Institution
MUSC
Recruitment Contact
Lindsey Owens
(843) 792-8233
owensli@musc.edu

A Multi-Center Trial of the ProLung Test™ (Transthoracic Bioconductance Measurement) as an Adjunct to CT Chest Scans for the Risk Stratification of Patients with Pulmonary Lesions Suspicious for Lung Cancer Save

Date Added
April 26th, 2017
PRO Number
Pro00062336
Researcher
Gerard Silvestri

Silhouette
Keywords
Cancer/Lung, Pulmonary
Summary

This study examines a new device and technology that aims to detect how likely a lung nodule or lesion is cancerous. The technology is called the ProLung Test™ and it is noninvasive and has already been been evaluated for safety. The goal of this study is to optimize and validate the test and further asses its safety and tolerability.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

A feasibility study assessing exercise level and quality of life in patients with lung cancer. Save

Date Added
August 11th, 2016
PRO Number
Pro00052856
Researcher
Gerard Silvestri

Silhouette
Keywords
Cancer/Lung, Exercise, Lung
Summary

Self administered-surveys will be conducted of patients with advanced stage lung cancer who utilize the Hollings Cancer Center and East Cooper multidisciplinary thoracic oncology clinic for medical care. Information about their activity level and quality of life will be collected. Baseline activity level will be monitored for one week based on amount of steps recorded on the Fitbit® pedometer, and a physical activity prescription will be given for an additional three weeks. The results will help determine if exercise is beneficial to lung cancer patients and if exercise as an adjuvant treatment is viable.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

The Watch the Spot Trial Save

Date Added
June 10th, 2016
PRO Number
Pro00044920
Researcher
Gerard Silvestri

Silhouette
Keywords
Cancer, Lung, Pulmonary
Summary

The study will compare two sets of professionally-recommended guidelines for follow-up of patients with small lung nodules. The two guidelines are different in the frequency and timing of follow-up; one is more frequent and the one is less frequent. All patients who have a small lung nodule detected on a chest scan will have a recommended follow-up schedule automatically inserted into their imaging report so that their health care provider may follow the guideline-recommended intervals for follow-up chest scans. Patients and their physicians may choose not to follow the recommendations, depending on preference or the physician's clinical judgment. As part of this research study, information from patients with a small lung nodule who are seen at MUSC will be collected from the electronic medical record. This will include characteristics of the patient (such as age, smoking history), basic information about the lung nodule (such as nodule size, nodule density), and the medical care received.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

Blood Sample Collection in Subjects with Pulmonary Nodules or CT Suspicion of Lung Cancer Save

Date Added
March 22nd, 2016
PRO Number
Pro00051821
Researcher
Gerard Silvestri

Silhouette
Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The main objective of this study is to better understand the biomarkers of patients with abnormal CT (computed tomography) scans of the lungs. Biomarkers are biologic substances found in the blood and may be related to lung disease risk and detection. We intend to enroll volunteers with abnormal CT scans who are being evaluated by an MUSC pulmonologist as part of their standard medical care. A single blood sample will be obtained, then stored and analyzed to better understand the biomarkers found in blood and to help develop blood-based screening or diagnostic tests. Active participation in this study will be over once a blood sample is obtained. However, we may conduct medical chart reviews of some participants for up to 27 months in order to look at their medical outcomes.

Institution
MUSC
Recruitment Contact
Lindsey Owens
(843) 792-8233
owensli@musc.edu

Prospective Registry to Evaluate Percepta Bronchial Genomic Classifier Patient Data: The PERCEPTA Registry Save

Date Added
October 29th, 2015
PRO Number
Pro00048117
Researcher
Gerard Silvestri

Silhouette
Keywords
Cancer, Lung, Pulmonary
Summary

Percepta is a new test that analyzes the cells that line the airways of the lungs to identify patients who are at low risk for lung cancer. It helps physicians decide which patients they can safely treat by follow-up CT scans instead of having to undergo a more invasive procedure, such as surgery.

Institution
MUSC
Recruitment Contact
Katherine Taylor
843-792-2297
taylkat@musc.edu

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