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.