NCT06678334

Brief Summary

Chronic rhinitis is a common chronic nasal mucosal inflammatory disease. Its clinical symptoms and severity are diverse, mainly including allergic rhinitis, local allergic rhinitis, non-allergic rhinitis with hypereosinophilia syndrome and idiopathic rhinitis. All kinds of rhinitis have clinical symptoms such as nasal congestion, runny nose, sneezing, and nasal itching, but the causes are different. At present, the complicated diagnostic methods of different subtypes of chronic rhinitis are an important factor restricting the improvement of clinical diagnosis and treatment. Based on the found key markers of each subtype of chronic rhinitis, the establishment of a non-invasive classification diagnostic method of chronic rhinitis with nasal secretion as the core is of great practical significance for optimizing the existing clinical diagnosis system and improving the efficiency of clinical diagnosis

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
80mo left

Started Nov 2024

Longer than P75 for all trials

Status
not yet recruiting

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

Study Progress19%
Nov 2024Dec 2032

First Submitted

Initial submission to the registry

November 6, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 6, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

4.1 years

First QC Date

November 6, 2024

Last Update Submit

November 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The signature transcriptomic, proteomic, and metabolomic indicators or combinations of nasal secretions of different subtypes of chronic rhinitis

    The signature transcriptomic, proteomic, and metabolomic indicators or combinations of nasal secretions of different subtypes of chronic rhinitis, which have high sensitivity and specificity in the diagnosis of a specific chronic rhinitis.

    3 years

Study Arms (1)

chronic rhinitis

In this study, no additional intervention was performed on the patients. Only nasal secretions and blood samples were collected from patients with chronic rhinitis in our hospital.

Eligibility Criteria

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

All Patients in the First Affiliated Hospital, Nanjing Medical University and volunteering for this study

You may qualify if:

  • Age 18-65 years old;
  • Patients with chronic rhinitis in the Department of Otorhinolaryngology, the First Affiliated Hospital of Nanjing Medical University;
  • Patients who are willing to provide specimens for free to promote the diagnosis of chronic rhinitis.

You may not qualify if:

  • Patients received glucocorticoids, immunomodulatory drugs, antihistamines, and other treatments that may affect the study results within the past 1 month.
  • Patients with unstable diseases (including severe asthma) and active immune system diseases;
  • Smoking;
  • Pregnant or lactating women; History of nasal surgery within 5.3 months;
  • \. Patients with low compliance and refusing to accept specimen and questionnaire collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Collection of plasma and nasal secretions

Study Officials

  • Lei Cheng, PhD

    The First Affiliated Hospital, Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

Yanbing Chen MBBS, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 7, 2024

Study Start

November 6, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2032

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

All the individual participant data only available to reasearchers participated in this study