Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.

December 5, 2018 updated by: Rana F Hilal, MD, Kasr El Aini Hospital

A 4mm Punch biopsy is obtained from lesional and non lesional skin of 25 psoraitic patients as well as of 30 controls.

Skin biopsy from patients (psoriasis lesional and non lesional) & control will be kept in lysis solution (which contains RNAase inhibitor) for the stability of the parameter to be assessed. ERAP-1 gene expression will Research Template 5 Final Version: 8/3/2 016 be detected by quantitative real time -PCR, which include RNA extraction, cDNA synthesis & PCR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with psoriasis vulgaris
  • patients over 18 years of age
  • both sexes

Exclusion Criteria:

  • patients on treatment for psoriasis within the last two months
  • assoiciated autoimmune diseases eg SLE
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cases of psoriasis
group of 25 cases of psoriasis subjected to skin biopsy for detection of lesional and non lesional expression of ERAP1 by RT-PCR
Diagnostic test: RT-PCR for ERAP1 detection
Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection
Experimental: normal controls
group of 30 age and sex matched healthy controls o subjected to skin biopsy from normal skin for detection of expression of ERAP1 by RT-PCR
Diagnostic test: RT-PCR for ERAP1 detection
Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimation of lesional ERAP1 in psoriatic skin
Time Frame: Maximum 2 years
DPCRetection of level of expression of ERAP 1 in lesional skin of psoriasis patients by RT-
Maximum 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimation of non lesional ERAP1 in psoriatic skin
Time Frame: Maximum 2 years
Detection of level of expression of ERAP 1 in non lesional skin of psoriasis patients by RT-PCR.
Maximum 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

December 5, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EgyERAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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