NanoSpectrometer Biomarker Discovery and Confirmation Study

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: Breath Analysis

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
• Enrollment (Actual): 332

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stage 1 Lung Cancer (Case); These are the participants with identified stage 1 lung cancer.	Diagnostic test: Breath Analysis; Breath will be analyzed in all three groups using gas chromatography mass spectrometry.; Other Names: Gas Chromatography Mass Spectrometry
Type 1 Control; These are participants who have similar clinical characteristics as our cases, but do not have any history of cancer.	Diagnostic test: Breath Analysis; Breath will be analyzed in all three groups using gas chromatography mass spectrometry.; Other Names: Gas Chromatography Mass Spectrometry
Type 2 Control; These are housemates of the participants with stage 1 lung cancer (cases).	Diagnostic test: Breath Analysis; Breath will be analyzed in all three groups using gas chromatography mass spectrometry.; Other Names: Gas Chromatography Mass Spectrometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volatile organic compounds present in our cases but not controls.	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.	1.5 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Nanobeak Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 5, 2017
• Primary Completion (ACTUAL): July 6, 2020
• Study Completion (ACTUAL): July 6, 2020

Study Registration Dates

• First Submitted: September 1, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (ACTUAL): September 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: lung cancer; clinical trial; screening; VOC; volatile organic compound
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: IRB00121967

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No