NCT05999838

Brief Summary

To establish a simplified approach for assessment of severity of interstitial lung disease by evaluating the relationship between HRCT findings, the clinical severity score,spirometry and quality of life.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

July 11, 2023

Last Update Submit

August 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation of visual based scoring system of HRCT and pulmonary function test.

    1 year

Secondary Outcomes (1)

  • assessment of ILDs patients quality of life and correlation with HRCT finding and PFTs.

    1 year

Interventions

CT-based semi-quantitative scoring will be calculated according to number of lung segments affected on both sides. The finding on each segment will be given a score from 1 to 4 as follows: 1. for ground glass opacities. 2. for reticulations and fibrotic changes. 3. for bronchiectatic changes. 4. for honeycombing and sub-pleural cysts.

Also known as: spirometry

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted at Chest Department or presented to our out patient clinic with clinical diagnosis of Interstitial Lung Diseases

You may qualify if:

  • All patients admitted at Chest Department or presented to our out patient clinic with clinical diagnosis of Interstitial Lung Diseases among both sexes

You may not qualify if:

  • patients under 18 years old.
  • pregnant patients.
  • patients with a history of previous lung resections.
  • presence of bronchial carcinoma or lobar consolidation.
  • patients contraindicated to perform pulmonary function will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Dina W. Fahim, resident doctor

CONTACT

Nermeen M. Abu Elkassem, Lecturer

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 11, 2023

First Posted

August 21, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

February 1, 2025

Last Updated

August 21, 2023

Record last verified: 2023-08