NCT06427018

Brief Summary

Asthma, a prevalent chronic respiratory affliction, significantly impinges upon the quality of life for affected individuals. Timely and appropriate diagnostic measures, coupled with efficacious therapeutic interventions, are paramount in mitigating exacerbations of symptoms and enhancing the life quality of patients. Ezrin plays an important role in maintaining cell morphology, cell migration, cell adhesion and polarisation, but Ezrin expression in airway smooth muscle remains unclear. Pip5k1α is an important kinase involved in intracellular phosphatidylinositol signalling pathways that may be involved in smooth muscle contraction and diastole. Therefore, further studies are necessary to elucidate the changes of Ezrin and Pip5k1α in patients with asthma to provide a basis for investigating alternative treatments for asthma.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress75%
May 2024Dec 2026

First Submitted

Initial submission to the registry

May 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

May 28, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

May 19, 2024

Last Update Submit

January 12, 2026

Conditions

Keywords

AsthmaEzrinPip5k1αAirway smooth muscle

Outcome Measures

Primary Outcomes (2)

  • Immunofluorescence results

    IF

    6 months

  • Immunohistochemistry results

    IHC

    6 months

Study Arms (2)

Asthma group

No intervention.

Other: No intervention.

Non-asthma group

No intervention.

Other: No intervention.

Interventions

Observational study with no intervention.

Asthma groupNon-asthma group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Referring to previous validation studies of target proteins in the literature, the sample size required for this validation experiment is related to multiple factors: (1) Selection of genes: mRNA differentially expressed genes will have a 50% probability of differential protein expression. (2) Antibody selection: Commercially available antibodies will be used for immunohistochemical detection of formalin-fixed, paraffin-embedded tissues with a success rate of up to 75%. According to previous validation studies of the target protein, the required samples are 60 in each group, for a total of 120 samples.

You may qualify if:

  • Lung tissue samples;
  • The samples come from patients aged 18-70 years old, regardless of gender, who underwent lung tissue sampling for surgical indications during treatment;
  • Paraffin sections of lung tissue from patients diagnosed with bronchial asthma, including tracheal smooth muscle;
  • Paraffin sections of lung tissue from non-asthma patients, including tracheal smooth muscle.

You may not qualify if:

  • Paraffin sections of lung tissue from patients who have been diagnosed with COPD;
  • Other situations where the researcher deems it inappropriate to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yueyang Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Lei-Miao Yin, MD

    Yueyang Hospital, Shanghai University of Traditional Chinese medicine

    STUDY DIRECTOR
  • Wei-Wei He, MD

    Shanghai 6th People's Hospital

    STUDY DIRECTOR
  • Jun-Tao Feng, MD

    Xiangya Hospital of Central South University

    STUDY DIRECTOR
  • Li Li, MD

    Baoshan Hospital, Shanghai University of Traditional Chinese Medicine

    STUDY DIRECTOR
  • Xiao-Ling Xu, MD

    Shanghai Pulmonary Hospital, Tongji University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 19, 2024

First Posted

May 23, 2024

Study Start

May 28, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations