NCT01437033

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2016

Completed
Last Updated

April 5, 2018

Status Verified

September 23, 2016

First QC Date

September 16, 2011

Last Update Submit

April 4, 2018

Conditions

Keywords

Breath TestsHuman VolunteersPilot StudyBreath Test

Outcome Measures

Primary Outcomes (1)

  • Statistics of robustness (CV, ICCs)

    98 days

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DCEG volunteers aged 30-60 years, inclusive.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 20647397BACKGROUND
  • 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. doi: 10.1002/ijc.10427.

    PMID: 12115489BACKGROUND
  • 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. No abstract available.

    PMID: 21454418BACKGROUND

Study Officials

  • Michael B Cook, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2011

First Posted

September 20, 2011

Study Start

August 29, 2011

Study Completion

September 23, 2016

Last Updated

April 5, 2018

Record last verified: 2016-09-23

Locations