RECRUITING

Olfactory Biopsies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study aims to investigate the function of the olfactory lining in the nasal cavity and its potential alterations in both healthy and diseased conditions. The olfactory lining is involved in the sense of smell. The purpose of this study is to collect tissue from the nasal cavity.

Official Title

Analysis of Human Olfactory Biopsies

Quick Facts

Study Start:2025-01-06
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07021040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 18 and 80
  2. * Pre-clinical AD (this cohort consists of subjects who have normal cognitive testing and function, but have positive AD biomarkers);
  3. * Symptomatic AD (a confirmed diagnosis of Alzheimer's or dementia who are capable of understanding and signing the consent document)
  1. * Advanced Alzheimer's/dementia
  2. * Self-reported or known allergy to Afrin or Tetracain HCL (or related class of drugs)
  3. * Active Rhinosinusitis symptoms
  4. * Other known sinonasal disease history that would preclude biopsy (i.e prior sinus or skull base surgery directly impacting this anatomic region, sinonasal neoplasm in this anatomic region, olfactory cleft polyps)
  5. * Parkinson's disease
  6. * Unable or willing to complete the nasal endoscopy procedure.
  7. * Unable to read or speak English
  8. * Unable to provide legally effective consent

Contacts and Locations

Study Contact

Maria J Manson, MBA
CONTACT
(919) 684-0525
maria.manson@duke.edu
Bradley J Goldstein, MD, PhD
CONTACT
(919) 684 3834
bradley.goldstein@duke.edu

Principal Investigator

Bradley Goldstein, MD, PhD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University Health Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Bradley Goldstein, MD, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-06
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-01-06
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • act-seq
  • nasal biopsy
  • RNA-seq

Additional Relevant MeSH Terms

  • Alzheimer Disease
  • Smell Loss
  • Smell Dysfunction