Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01437033
Other study ID # 999911243
Secondary ID 11-C-N243
Status Completed
Phase
First received September 16, 2011
Last updated April 4, 2018
Start date August 29, 2011
Est. completion date September 23, 2016

Study information

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

Clinical Trial 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


Description:

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:

DCEG volunteers aged 30-60 years, inclusive.

Design:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Cancer Institute (NCI), 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — 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

Outcome

Type Measure Description Time frame Safety issue
Primary Statistics of robustness (CV, ICCs) 98 days
See also
  Status Clinical Trial Phase
Completed NCT03093506 - Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance Early Phase 1
Completed NCT00526968 - The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function Phase 1
Completed NCT03277456 - A Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1 Early Phase 1
Completed NCT02922933 - A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects Phase 1
Completed NCT01452425 - In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome Phase 1
Completed NCT01464385 - Nutrition Beverage Tolerance Study Phase 2
Completed NCT01468714 - A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects Phase 1
Completed NCT02922946 - Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat Phase 1
Completed NCT00254449 - Effect of NGX-4010 on ENFD and Sensory Function Phase 1
Completed NCT01618903 - An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese Phase 1
Completed NCT01618877 - A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers Phase 1
Completed NCT00752466 - A Drug Interaction Study of the Pharmacokinetics of Topiramate and FLUNARIZINE When Given Together or Separately Phase 1
Completed NCT00166933 - Minimal Erythema Dose of UV-B in Normal Population of Taiwan N/A
Completed NCT05519514 - Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects Phase 1
Completed NCT01776437 - Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers Phase 1
Completed NCT01445860 - Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics Phase 1
Unknown status NCT00743977 - Bioequivalence of Phenazopyridine HCl in Healthy Volunteers N/A
Completed NCT00744809 - TMC278-TiDP6-C152: A Study to Assess the Effects of TMC278 and Efavirenz (EFV) on the QT/QTc Interval (Heart Conduction and Heart Rhythm) in Healthy Volunteers. Phase 1