Structure and Function of Salivary Proteins

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Children's Hospital Boston.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Tufts University
Boston University
Boston Medical Center
University of North Carolina, Chapel Hill
Ahura Scientific, Inc.
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00916682
First received: June 5, 2009
Last updated: June 8, 2009
Last verified: June 2009
  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: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Structure and Function of Salivary Proteins

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of North Carolina, Chapel Hill
Ahura Scientific, Inc.
Investigators
Principal Investigator: Ahmet Uluer, DO Children's Hospital Boston
  More Information

No publications provided

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

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014