Tracking Information
First Submitted Date September 1, 2017
First Posted Date September 7, 2017
Last Update Posted Date December 3, 2019
Actual Study Start Date September 5, 2017
Actual Primary Completion Date November 20, 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
(submitted: September 19, 2017) Volatile organic compounds present in our cases but not controls. [ Time Frame: 1.5 years ]
Volatile organic compounds will be measured between the cases and both types of controls. We will report the different volatile organic compound fingerprints that are present in cases and not in controls.
Original Primary Outcome Measures
(submitted: September 5, 2017) Identify volatile organic compounds present in our cases but not controls. [ Time Frame: 1.5 years ]
Volatile organic compounds will be measured between the cases and both types of controls. We will report the different volatile organic compound fingerprints that are present in cases and not in controls.
Change History Complete list of historical versions of study NCT03275688 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title NanoSpectrometer Biomarker Discovery and Confirmation Study
Official Title NanoSpectrometer Biomarker Discovery and Confirmation Study
Brief Summary This study will evaluate exhaled volatile organic compounds (VOC's) in the breath of participants with stage 1 lung cancer, their house-mates, and matched controls. The goal of the study is to identify VOC fingerprints that are only detectable in those with stage 1 lung cancer.
Detailed Description
Lung cancer is by far the leading cause of cancer death in the United States. More people die annually of lung cancer than of colon, breast, and prostate cancers combined. Worldwide it is already the leading cause of cancer death among males, and with smoking rates substantially higher in developing countries relative to the United States the worldwide burden of lung cancer is projected to increase considerably in the future.
For lung cancer, as for many cancers, early diagnosis allowing for full resection offers the greatest chance for long-term survival, but unfortunately these individuals currently constitute only a minority of the lung-cancer population. Screening technologies that allow for the earliest detection of lung cancer would therefore have tremendous potential to substantially improve outcomes. Recently, and for the first time, a screening test for lung cancer of high risk individuals has been recommended by the US Preventive Services Task Force, as well as others, for the reduction of lung cancer mortality. This recommendation was based primarily on the results of the National Lung Screening Trial (NLST) that randomized over 53,000 individuals considered at high risk for lung cancer to 3 annual screenings with either low-dose CT (LDCT) or a chest x-ray and then followed for a median of 6.5 years. In this study LDCT scanning was associated with a statistically significant 20% relative decrease in lung cancer mortality, and a smaller, but still significant 6.7% decrease in overall mortality. Despite these encouraging results of LDCT, as a screening tool it has substantial limitations. Beyond the costs, inconvenience and radiation exposure associated with LDCT, its performance characteristics are far from optimal. For example, nearly a quarter of the LDCT population had a positive screening test, with the vast majority - 96.4% - proving to be false-positive. With a positive predictive value of <4% LDCT screening will lead to a great number of unnecessary diagnostic procedures as well as substantial anxiety in the screened population and their family.
Breath analytics is a new and very promising tool for diagnosing lung cancer, as well as multiple other conditions. Previous studies identified that dog's heightened olfactory senses were able to detect cancer in an individual's breath with an accuracy of nearly 100%. Since then attempts have been made to mimic canine capabilities with "electronic noses" to detect and quantitate the nearly 3000 compounds, many in the parts per billion or even parts per trillion ranges, in exhaled breath. Early studies of these technologies support great potential as a diagnostic and screening tool. As a screening tool it could be ideal as it is noninvasive, painless and free of any undesirable side effects. In addition, new advances in nanotechnology have allowed these extremely sensitive detection technologies to be miniaturized to the point that they can be linked to a smartphone, providing future possibilities to almost continuously surveil individuals for the development of lung cancer and other life-threatening conditions. This study is concerned with comparing the concentrations of volatile organic compounds (VOCs) in the breath of lung cancer patients (cases) and lung-cancer-free individuals (controls).
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention: Samples Without DNA
Description:
Breath sample
Sampling Method Non-Probability Sample
Study Population The study population will consist of three groups. Our cases will be those who have been diagnosed with stage 1 lung cancer. Our type 1 controls will consist of participants who do not have lung cancer, but otherwise have similar clinical characteristics of our cases. the type 2 controls will be people who live in the same house as our stage 1 lung cancer patients (cases).
Condition Lung Cancer
Intervention Diagnostic Test: Breath Analysis
Breath will be analyzed in all three groups using gas chromatography mass spectrometry.
Other Name: Gas Chromatography Mass Spectrometry
Study Groups/Cohorts
Stage 1 Lung Cancer (Case)
These are the participants with identified stage 1 lung cancer.
Intervention: Diagnostic Test: Breath Analysis
Type 1 Control
These are participants who have similar clinical characteristics as our cases, but do not have any history of cancer.
Intervention: Diagnostic Test: Breath Analysis
Type 2 Control
These are housemates of the participants with stage 1 lung cancer (cases).
Intervention: Diagnostic Test: Breath Analysis
Publications * Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
(submitted: November 29, 2019) 332
Original Estimated Enrollment
(submitted: September 5, 2017) 450
Actual Study Completion Date November 20, 2019
Actual Primary Completion Date November 20, 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria
Inclusion Criteria:
Adults age 18 and over with diagnosed Stage 1 Lung Cancer (cases)
Adults age 18 and over without Lung cancer (type 1 controls)
Adults age 18 and over who live in the same environment as the cases (type 2 controls)
Exclusion Criteria N/A
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries
Administrative Information
NCT Number NCT03275688
Other Study ID Numbers IRB00121967
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators Nanobeak Inc.
Investigators
Principal Investigator: Lonny Yarmus, DO Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date November 2019
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