Study Stopped
Funding was not able to be secured for the study and no participants enrolled.
Natural History of Granulomatosis With Polyangiitis: Clinical and Genetic Biomarkers of Airway Disease NoAAC PR-03 Study
NoAAC PR-03
1 other identifier
observational
N/A
1 country
1
Brief Summary
The ultimate goal of this prospective natural history study is to define the natural history of the obstructive airway manifestations of Granulomatosis with polyangiitis (GPA). Additionally this proposal seeks to develop biomarkers of disease activity and define their correlation with clinical outcomes in an effort to transform clinical care and shape future drug development for this devastating rare disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedAugust 25, 2020
August 1, 2020
1.4 years
June 5, 2017
August 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to recurrent intervention (TTR)
The time between interventions aimed at preserving an open airway.
5 years
Secondary Outcomes (5)
Patient Reported Outcome Measures
5 years
Patient Reported Outcome Measures
5 years
Patient Reported Outcome Measures
5 years
Patient Reported Outcome Measures
5 years
Disease Assessment clinical tool
5 years
Study Arms (1)
GPA (Wegener's granulomatosis) patients
Interventions
Airway Specialist (Otolaryngology, Pulmonology, Thoracic Surgery), assess clinical location and degree of airway compromise, glottic mobility, and sinonasal disease.
Clinically assess systemic function (renal/pulmonary ect), biochemical profile (routine labs), neurocognitive function, and completing entry BVAS tool.
Eligibility Criteria
Adult Granulomtosis with Polyangiitis Population Affected by Obstructive Airway Disease patients are eligible for enrollment.
You may qualify if:
- Greater than or equal to 18 years of age.
- Stenotic Airway Disease (laryngeal, subglottic, distal tracheal or bronchial)
You may not qualify if:
- \<18years of age
- Patients without capacity to consent for themselves
- History of significant laryngotracheal traumatic injury.
- Endotracheal intubation 2 years prior to presentation.
- Major anterior neck surgery.
- History of neck irradiation.
- History of caustic or thermal injury to the laryngotracheal complex.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Biospecimen
We plan to obtain a small amount of blood at a time when other medically indicated labs, operative or office-based procedures occur. Excess tissue obtained at standard of care surgical biopsy will be preserved for molecular study.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Gelbard, MD
Vanderbilt University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Otolaryngology
Study Record Dates
First Submitted
June 5, 2017
First Posted
June 9, 2017
Study Start
December 1, 2020
Primary Completion
May 1, 2022
Study Completion
May 1, 2023
Last Updated
August 25, 2020
Record last verified: 2020-08