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Human Sinonasal Mucosa Heterogeneity Study

2. juli 2026 opdateret af: Yanran Huang, First Affiliated Hospital, Sun Yat-Sen University

Heterogeneity of Mucosa Across Different Human Sinonasal Sites: An Observational Study

This observational study aims to better understand how the lining of the nose and sinuses differs across different sinonasal sites in humans, including participants with and without sinonasal inflammatory disease. Mucosal tissue samples will be collected from participants who are undergoing clinically indicated sinonasal surgery. The study will compare tissue structure, gene expression, protein expression, and immune cell composition among different regions of the sinonasal mucosa.

By studying these differences, researchers hope to identify site-specific features of human sinonasal mucosa and improve understanding of normal and disease-related changes in the nose and sinuses. This study does not assign participants to any treatment or intervention. The findings may provide a foundation for future research on chronic rhinosinusitis, nasal polyps, and other sinonasal diseases.

Studieoversigt

Status

Rekruttering

Detaljeret beskrivelse

The human sinonasal mucosa lines different regions of the nasal cavity and paranasal sinuses and plays an important role in mucosal defense, inflammation, and tissue homeostasis. However, the biological characteristics of mucosa from different sinonasal sites are not fully understood.

This observational study will collect sinonasal mucosal tissue samples from participants undergoing clinically indicated sinonasal surgery. Samples may be obtained from different anatomical sites of the sinonasal tract when available as part of the surgical procedure. No treatment or intervention will be assigned by the study.

Collected samples will be analyzed to compare site-specific features of human sinonasal mucosa, including tissue structure, gene expression patterns, protein expression profiles, and immune cell composition. Relevant clinical information may also be collected to support interpretation of the biological findings.

The purpose of this study is to characterize the heterogeneity of human sinonasal mucosa across different anatomical sites. The results may help improve understanding of normal sinonasal mucosal biology and provide a reference for future studies of chronic rhinosinusitis, nasal polyps, and other sinonasal inflammatory diseases.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will include adult participants undergoing clinically indicated sinonasal surgery. Sinonasal mucosal tissue samples may be collected from different anatomical sites of the nasal cavity and paranasal sinuses when available during the planned surgical procedure. Participants may include individuals with sinonasal inflammatory disease as well as individuals undergoing surgery for non-inflammatory sinonasal conditions, depending on clinical availability and protocol requirements. No study-specific treatment or intervention will be assigned.

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Scheduled for clinically indicated sinonasal surgery.
  • Sinonasal mucosal tissue can be collected during surgery without significant additional risk.
  • Able and willing to provide written informed consent.
  • Relevant clinical information is available.

Exclusion Criteria:

  • Unable or unwilling to provide informed consent.
  • Younger than 18 years of age.
  • Tissue collection may interfere with standard care or increase surgical risk.
  • History of sinonasal malignancy, sinonasal radiotherapy, or chemotherapy affecting sinonasal mucosa.
  • Active systemic infection or severe systemic disease affecting study participation or interpretation.
  • Use of systemic corticosteroids, immunosuppressants, or biologics within 4 weeks before surgery.
  • Insufficient or poor-quality tissue for planned analyses.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
sund kontrol
sunde mennesker
CRSwNP
CRSwNP patient

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Site-Specific Heterogeneity of Human Sinonasal Mucosa
Tidsramme: Baseline
Differences in histological features, gene expression patterns, protein expression profiles, and immune cell composition will be compared among mucosal tissue samples collected from different anatomical sites of the human sinonasal tract. These analyses will be used to characterize site-specific biological features and support construction of a human sinonasal mucosal spatial atlas.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2025

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

25. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Human Sinonasal Mucosa Heterog

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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