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Survivin and Fibulin-3 in Benign and Malignant Respiratory Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04413292
Recruitment Status : Completed
First Posted : June 2, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Mohammed H. Hassan, South Valley University

Brief Summary:

Purpose: Survivin is a common member of the inhibitors of the apoptosis protein (IAP) family with a dual role in promoting cell proliferation and preventing apoptosis. Fibulin-3, a matrix glycoprotein, was recently presented as a promising novel biomarker for malignant pleural mesothelioma. The aim of this study was to validate the expression levels of survivin and fibulin-3 in benign and malignant respiratory diseases.

Patients and methods: The study included 73 patients, with various benign and malignant respiratory diseases. For validation of the data, a control group including 20 healthy subjects was chosen. The clinical and radiological assessments of the included individuals were done. The serum survivin and fibulin-3 levels were measured using ELISA assays kits, while their local expressions in the lung and pleura were assessed using western blot analysis.


Condition or disease Intervention/treatment
Bronchial Neoplasm Benign Diagnostic Test: ELISA assays and Westren blot analysis of survivin and fibulin-3 expression

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Study Type : Observational
Actual Enrollment : 93 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Circulating and Local Expression Levels of Survivin and Fibulin-3 in Benign and Malignant Respiratory Diseases
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group A
21 patients with lung cancer
Diagnostic Test: ELISA assays and Westren blot analysis of survivin and fibulin-3 expression
expression analysis of biomarkers

Group B
21 patients with various benign lung diseases
Diagnostic Test: ELISA assays and Westren blot analysis of survivin and fibulin-3 expression
expression analysis of biomarkers

Group C
Healthy controls
Diagnostic Test: ELISA assays and Westren blot analysis of survivin and fibulin-3 expression
expression analysis of biomarkers

Group D
15 patients with malignant pleural mesothelioma (MPM)
Diagnostic Test: ELISA assays and Westren blot analysis of survivin and fibulin-3 expression
expression analysis of biomarkers

Group E
16 patients having various benign pleural diseases
Diagnostic Test: ELISA assays and Westren blot analysis of survivin and fibulin-3 expression
expression analysis of biomarkers




Primary Outcome Measures :
  1. analyze the local and circulating expression levels of both biomarkers in various benign and malignant lung and pleural diseases [ Time Frame: 2 years ]
    find out the possible correlations between them and their utility in diagnosing and discriminating malignant from benign lesions that affect the respiratory tract.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
any patients with Benign or Malignant Respiratory Diseases and agree to included in the study in addition to healthy controls
Criteria

Inclusion Criteria:

  • any patients with Benign or Malignant Respiratory Diseases and agree to included in the study

Exclusion Criteria:

  • Patients with renal failure, hepatic failure, severe cardiopulmonary compromise, coagulopathy or hemodynamically unstable were excluded
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Responsible Party: Mohammed H. Hassan, Associate Professor of Medical Biochemistry, Faculty of Medicine , South Valley University, South Valley University
ClinicalTrials.gov Identifier: NCT04413292    
Other Study ID Numbers: SVU-QFM-100
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammed H. Hassan, South Valley University:
Survivin; Fibulin-3; Lung cancer; MPM
Additional relevant MeSH terms:
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Bronchial Neoplasms
Respiration Disorders
Respiratory Tract Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Diseases
BIRC5 protein, human
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action