Breath Test for Chemicals (Volatile Organic Compounds)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01437033
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : April 5, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


- Some types of cancer, like cancer of the esophagus, are difficult to detect at an early stage. A possible detection method involves collecting breath samples to look for chemicals that may be signs of cancer. However, more research is needed to determine how different chemicals appear in different breath samples. This study will involve healthy volunteers.


- To study chemicals appearing in breath samples of healthy volunteers.


- Healthy volunteers between 30 and 60 years of age.


  • Participants will fast overnight (midnight to morning) and then provide two breath samples taken 5 minutes apart.
  • Breath samples will be collected on days 1, 49, and 98 of the study

Condition or disease
Breath Tests Human Volunteers Pilot Study

Detailed Description:


Although breath tests are common for specific uses where the biomarker is highly concentrated (e .g. alcohol, urea for Helicobacter prylori infection), lower concentration compounds in the breath can also provide information on exogenous exposures and endogenous metabolic processes.

Employing standardized collection techniques and high sensitivity measurement technologies have shown that breath profiles can accurately identify people with diseases such as breast cancer and lung cancer.

Breath profiling technologies have great potential as non-invasive tools for diagnosis and risk stratification of precancerous disease as well as elucidation of the causes of cancer.

Prior to using breath profiles for these purposes it is essential to assess how much of the breath profile and which parts of the breath profile are relatively stable over a period of time.


The primary objective of this pilot study is to assess the intra-individual variability of breath profiles sampled over a period of 98 days.


DCEG volunteers aged 30-60 years, inclusive.


Pilot study.

Five DCEG volunteers will be enrolled for this study.

We will assess breath profiles sampled in duplicate at three time periods (days 1, 49 and 98).

We will calculate a coefficients of variation (CV) to determine the proportion and parts of the breath profile which have values less than 10% when collected on the same day,49 days apart, and 98 days apart.

Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Pilot Study of a Breath Test for Assessment of Volatile Organic Compounds
Study Start Date : August 29, 2011
Study Completion Date : September 23, 2016

Primary Outcome Measures :
  1. Statistics of robustness (CV, ICCs) [ Time Frame: 98 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DCEG volunteers aged 30-60 years, inclusive.


Aged less than 30 years. Aged 61 years or older. Individuals who identify themselves to be in any one of the following categories over the next 4 month period:

  • Plan to initial a large change in their daily amount of physical activity
  • Plan to make large changes to their diet (reduce caloric intake, become a vegetarian etc)
  • May possibly move away from the area for a new job, sabbatical, retirement etc
  • Plan to attempt to become pregnant
  • Have limited availability for any reason including prolonged vacation or business travel

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01437033

United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Michael B Cook, M.D. National Cancer Institute (NCI)