Structure and Function of Salivary Proteins

Structure and Function of Salivary Proteins

This study is currently recruiting participants.

Verified by Children's Hospital Boston, June 2009

First Received: June 5, 2009 Last Updated: June 8, 2009 History of Changes

Sponsors and Collaborators:	Children's Hospital Boston Tufts University Boston University Boston Medical Center The University of North Carolina, Chapel Hill Ahura Scientific, Inc.
Information provided by:	Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00916682

Purpose

This study seeks to provide point-of-care clinical diagnostic systems for the diagnosis of current disease status using saliva as a sample specimen.

Condition
Cystic Fibrosis

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Structure and Function of Salivary Proteins

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Estimated Enrollment:	200
Study Start Date:	November 2007
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cystic Fibrosis

Detailed Description:

The overall hypothesis of this study is that whole saliva and its components, due to its direct anatomic relation to the airways, provides a window on the composition and nature of the disease-specific response in the bronchial, sinus, and nasal airways. By examining proteins created in saliva, we hope to validate that saliva is an important diagnostic tool for for rapid analysis of respiratory status. We further propose that rapid salivary diagnostics will improve patient care in prevalent respiratory diseases with frequent health care utilization and high morbidity, such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF).

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects will be approached during their pulmonary clinic appointment or while they are inpatient at Children's Hospital, Boston.

Criteria

Inclusion Criteria:

• 6 or more years of age
• confirmed Cystic Fibrosis

Exclusion Criteria:

• Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916682

Contacts

Contact: Lamia Momen

617-355-6665

lamia.momen@childrens.harvard.edu

Locations

United States, Massachusetts
Children's Hosptital, Boston	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lamia Momen 617-355-6665 lamia.momen@childrens.harvard.edu
Principal Investigator: Ahmet Uluer, DO

Sponsors and Collaborators

Children's Hospital Boston

Tufts University

Boston University

Boston Medical Center

The University of North Carolina, Chapel Hill

Ahura Scientific, Inc.

Investigators

Principal Investigator:

Ahmet Uluer, DO

Children's Hospital Boston

More Information
Additional Information:

Related Info

No publications provided

Responsible Party:	Children's Hospital, Boston ( Ahmet Uluer, DO )
Study ID Numbers:	X07-03-0142
Study First Received:	June 5, 2009
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00916682 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis

Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases

Additional relevant MeSH terms:

Pathologic Processes Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Lung Diseases

Infant, Newborn, Diseases Pancreatic Diseases Cystic Fibrosis Fibrosis

ClinicalTrials.gov processed this record on June 12, 2009


http://www.clinicaltrials.gov/ct2/show/NCT00916682?term=cystic+fibrosis&recr=Open