NCT02719145

Brief Summary

This cross sectional study will be carried out on 30 subjects who will be recruited from the outpatient clinic of Chest Department, Tanta University Hospital. They will be classified into 3 groups: Group I: It will include 10 healthy volunteer subjects. Group II: It will include 10 asthmatic patients. Group III: It will include 10 COPD patients. miR-7, miR-20a, miR-21, miR-22, miR-145 and miR-155 will be measured in serum samples from all subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

March 19, 2016

Last Update Submit

April 23, 2018

Conditions

Keywords

micro RNAasthmaCOPD

Outcome Measures

Primary Outcomes (1)

  • miR-7, miR-20a, miR-21, miR-22, miR-145 and miR-155 in serum samples from control, asthma and COPD Egyptian subjects.

    6 months.

Study Arms (3)

Control group (group 1)

10 healthy volunteer subjects.

Asthma group (group 2)

10 asthmatic patients.

COPD group (group 3)

10 COPD patients.

Eligibility Criteria

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

This cross sectional study will be carried out on 30 subjects who will be recruited from the outpatient clinic of Chest Department, Tanta University Hospital. They will be classified into 3 groups: Group I: It will includ 10 healthy volunteer subjects. Group II: It will include 10 asthmatic patients. Group III: It will include 10 COPD patients.

You may qualify if:

  • Group 1: healthy volunteers with no history of chest troubles.
  • Group 2: 10 asthmatic patients with history of paroxysmal wheezing, dyspnea, chest distress, and/or coughing; with Reversible airflow limitation as will be measured by an increase in forced expiratory volume in one second (FEV1) of at least 12% and of more than 200 ml after inhalation of 200 μg salbutamol.
  • Group 3: 10 COPD patients who have chronic airflow limitation on spirometry (FEV1/FVC is less than 0.7), and the patients have irreversible airflow limitation as will be measured by an increase in (FEV1) by less than12% or less than 200 ml after inhalation of 200 μg salbutamol.

You may not qualify if:

  • Upper or lower respiratory tract infection during the month preceding the study.
  • Other chronic respiratory or systemic illness.
  • Usage of systemic steroids within 2 months prior to the study.
  • Inability to provide informed consent or who refused to draw off blood.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chest Department, Faculty of Medicine, Tanta University

Tanta, Gharbia Governorate, 31111, Egypt

Location

Related Publications (2)

  • Van Pottelberge GR, Mestdagh P, Bracke KR, Thas O, van Durme YM, Joos GF, Vandesompele J, Brusselle GG. MicroRNA expression in induced sputum of smokers and patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2011 Apr 1;183(7):898-906. doi: 10.1164/rccm.201002-0304OC. Epub 2010 Oct 29.

  • Wang Y, Yang L, Li P, Huang H, Liu T, He H, Lin Z, Jiang Y, Ren N, Wu B, Kamp DW, Tan J, Liu G. Circulating microRNA Signatures Associated with Childhood Asthma. Clin Lab. 2015;61(5-6):467-74. doi: 10.7754/clin.lab.2014.141020.

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Adel S Bediwy, MD

    Chest Department, Faculty of Medicine, Tanta University

    STUDY CHAIR
  • Salwa A Ganna, MD

    Chest Department, Faculty of Medicine, Tanta University

    PRINCIPAL INVESTIGATOR
  • Said Hammad, MD

    Clinical Pathology Department, Faculty of Medicine, Tanta University

    PRINCIPAL INVESTIGATOR
  • Abdel-Aziz A Zidan, PHD

    Director of Genomics and Proteomics Unit, Center of Excellence in Cancer Research, Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 19, 2016

First Posted

March 25, 2016

Study Start

October 1, 2015

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

April 25, 2018

Record last verified: 2018-04

Locations