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A Pilot Study of a Breath Test for Assessment of Volatile Organic Compounds


N/A
30 Years
60 Years
Open (Enrolling)
Both
Breath Tests, Human Volunteers, Pilot Study

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Trial Information

A Pilot Study of a Breath Test for Assessment of Volatile Organic Compounds


Background:

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.

Objectives:

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

Eligibility:

Volunteers aged 30-60 years.

Design:

Pilot study.

Five 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.

Inclusion Criteria


- INCLUSION CRITERIA:

DCEG volunteers aged 30-60 years, inclusive.

EXCLUSION CRITERIA:

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Stability of breath volatile organic compounds over a 98 day period

Principal Investigator

Michael B Cook, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999911243

NCT ID:

NCT01437033

Start Date:

August 2011

Completion Date:

Related Keywords:

  • Breath Tests
  • Human Volunteers
  • Pilot Study
  • Breath Tests
  • Human Volunteers
  • Pilot Study
  • Breath Test

Name

Location

National Cancer Institute (NCI), 9000 Rockville PikeBethesda, Maryland  20892