Chronic RhinitisNCT06678334
Characteristic Transcriptomic, Proteomic and Metabolomic Molecular Studies of Nasal Secretions From Chronic Rhinitis
An observational study of Chronic Rhinitis, run by The First Affiliated Hospital with Nanjing Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Rhinitis
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2024to 1 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Patients in the First Affiliated Hospital, Nanjing Medical University and volunteering for this study
Who may be able to join
- 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.
Who cannot join
- 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;
- 6. Patients with low compliance and refusing to accept specimen and questionnaire collection
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Characterization of Transcriptome, Proteome and Metabolome Molecules in Nasal Secretions of Different Subtypes of Chronic Rhinitis
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
Read the detailed description
To study the characteristic transcriptome, proteome and metabolome molecules of nasal secretions of different subtypes of chronic rhinitis, and to establish a non-invasive diagnostic method for chronic rhinitis based on nasal secretions.Nasal secretions and blood were collected from patients with chronic rhinitis.
- Conditions
- Chronic Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start6 Nov 2024 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinitisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Lei, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Lei Cheng, PhD, Study director, The First Affiliated Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678334
- Sponsor's protocol ID
- 2024-SR-580
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the individual participant data only available to reasearchers participated in this study
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Transcriptome, Proteome and Metabolome Molecules in Nasal Secretions of Different Subtypes of Chronic Rhinitis
- ClinicalTrials.gov ID
- NCT06678334
- Acronym / sponsor ID
- 2024-SR-580
- Conditions
- Chronic Rhinitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 6 Nov 2024 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
To study the characteristic transcriptome, proteome and metabolome molecules of nasal secretions of different subtypes of chronic rhinitis, and to establish a non-invasive diagnostic method for chronic rhinitis based on nasal secretions.Nasal secretions and blood were collected from patients with chronic rhinitis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Patients in the First Affiliated Hospital, Nanjing Medical University and volunteering for this study
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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;
- 6. Patients with low compliance and refusing to accept specimen and questionnaire collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The signature transcriptomic, proteomic, and metabolomic indicators or combinations of nasal secretions of different subtypes of chronic rhinitis
Time frame: 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No. All the individual participant data only available to reasearchers participated in this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Cheng, PhD study director
The First Affiliated Hospital, Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinitis, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Cheng, PhD (+8613776620807, chenglei@jsph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The signature transcriptomic, proteomic, and metabolomic indicators or combinations of nasal secretions of different subtypes of chronic rhinitis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.