NCT00970190

Brief Summary

The study examines the biochemistry underlying human olfaction in both normal and diseased states. The study aims are: 1. to determine the levels of cAMP in olfactory tissue from people with chronic rhinosinusitis and other nasal disorders. 2. to correlate preoperative olfactory function with cAMP levels from biopsied olfactory tissue. 3. to determine odorant and pheromone-mediated activation of cultured human olfactory sensory neurons using calcium imaging and 4. to determine odorant and pheromone-mediated activation of cultured human olfactory sensory neurons using "smell-chip" technology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

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 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

4.7 years

First QC Date

August 31, 2009

Last Update Submit

December 10, 2014

Conditions

Keywords

sinusitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the University of Washington Rhinology Clinic for evaluation of sinus problems

You may qualify if:

  • Subjects will be 18 years old and over and scheduled for one of the following:
  • endoscopic sinus surgery for chronic sinusitis
  • endoscopic transnasal approach to the pituitary for pituitary tumor removal
  • endoscopic inferior turbinectomy or septoplasty for nasal congestion
  • endoscopic repair of cerebrospinal fluid (CSF) leaks

You may not qualify if:

  • Subjects are excluded if they are unable to give informed consent or unable to complete self-administered questionnaires due to English language barrier, cognitive impairment, or severe medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples consist of discarded tissue resulting from the following clinical procedures: endoscopic sinus surgery for chronic sinusitis, endoscopic transnasal approach to the pituitary for pituitary tumor removal, endoscopic inferior turbinectomy or septoplasty for nasal congestion and endoscopic repair of CSF leaks. Samples will only be retained for 1 year post-surgery and then destroyed.

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Greg E Davis, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 2, 2009

Study Start

August 1, 2009

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 11, 2014

Record last verified: 2014-12

Locations