NanoSpectrometer Biomarker Discovery and Confirmation Study

NCT03275688 | Terminated DMC

• 1 other identifier: IRB00121967
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

lung cancer; volatile organic compound; screening; VOC; clinical trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Stage 1 Lung Cancer (Case)

These are the participants with identified stage 1 lung cancer.

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.

Diagnostic Test: Breath Analysis

Type 2 Control

These are housemates of the participants with stage 1 lung cancer (cases).

Diagnostic Test: Breath Analysis

Interventions

Breath Analysis DIAGNOSTIC_TEST

Breath will be analyzed in all three groups using gas chromatography mass spectrometry.

Also known as: Gas Chromatography Mass Spectrometry

Stage 1 Lung Cancer (Case); Type 1 Control; Type 2 Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Nanobeak Inc.: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breath sample

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Breath Tests

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Lonny Yarmus, DO

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 7, 2017
• Study Start: September 5, 2017
• Primary Completion: July 6, 2020
• Study Completion: July 6, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)