Human Volunteers Clinical Trial
Official title:
A Pilot Study of a Breath Test for Assessment of Volatile Organic Compounds
Verified date | September 23, 2016 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- 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.
Objectives:
- To study chemicals appearing in breath samples of healthy volunteers.
Eligibility:
- Healthy volunteers between 30 and 60 years of age.
Design:
- 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
Status | Completed |
Enrollment | 5 |
Est. completion date | September 23, 2016 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility |
- 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 |
Country | Name | City | State |
---|---|---|---|
United States | National Cancer Institute (NCI), 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Cook MB, Dawsey SM, Diaw L, Blaser MJ, Perez-Perez GI, Abnet CC, Taylor PR, Albanes D, Virtamo J, Kamangar F. Serum pepsinogens and Helicobacter pylori in relation to the risk of esophageal squamous cell carcinoma in the alpha-tocopherol, beta-carotene cancer prevention study. Cancer Epidemiol Biomarkers Prev. 2010 Aug;19(8):1966-75. doi: 10.1158/1055-9965.EPI-10-0270. Epub 2010 Jul 20. — View Citation
Perera FP. Cancer: the big questions to address in coming years. Cancer Epidemiol Biomarkers Prev. 2011 Apr;20(4):571-3. doi: 10.1158/1055-9965.EPI-11-0184. — View Citation
Vizcaino AP, Moreno V, Lambert R, Parkin DM. Time trends incidence of both major histologic types of esophageal carcinomas in selected countries, 1973-1995. Int J Cancer. 2002 Jun 20;99(6):860-8. Erratum in: Int J Cancer 2002 Oct 20;101(6):599. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Statistics of robustness (CV, ICCs) | 98 days |
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