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

A study testing RT-PCR for ERAP1 detection in people with Psoriasis, run by Kasr El Aini Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Psoriasis
What is being tested?: RT-PCR for ERAP1 detection
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: No sites listed yet
Study dates: Jan 2017to Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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.

Conditions: Psoriasis
Being tested: RT-PCR for ERAP1 detection
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RT-PCR for ERAP1 detectionDiagnostic test
Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection

Study groups in NCT03767114
Study group	Role	What they receive
cases of psoriasis	Experimental	group of 25 cases of psoriasis subjected to skin biopsy for detection of lesional and non lesional expression of ERAP1 by RT-PCR Receives: Diagnostic Test: RT-PCR for ERAP1 detection
normal controls	Experimental	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 Receives: Diagnostic Test: RT-PCR for ERAP1 detection

What is being measured

The primary outcome is the main question the study is designed to answer.

Estimation of lesional ERAP1 in psoriatic skin
DPCRetection of level of expression of ERAP 1 in lesional skin of psoriasis patients by RT-
Measured: Maximum 2 years

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2017Dec 2018

First posted6 Dec 2018
Study startJan 2017
Primary completionJun 2017
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03767114
Sponsor's protocol ID: EgyERAP
Status last verified: Dec 2018
First submitted: 5 Dec 2018
Last updated: 6 Dec 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.
ClinicalTrials.gov ID: NCT03767114
Acronym / sponsor ID: EgyERAP
Conditions: Psoriasis
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Kasr El Aini HospitalUniversity, hospital or other
Study start: Jan 2017 (actual)
Primary completion: Jun 2017 (actual)
Study completion: Dec 2018 (actual)
First posted: 6 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
cases of psoriasis	Experimental	Diagnostic Test: RT-PCR for ERAP1 detectiongroup of 25 cases of psoriasis subjected to skin biopsy for detection of lesional and non lesional expression of ERAP1 by RT-PCR
normal controls	Experimental	Diagnostic Test: RT-PCR for ERAP1 detectiongroup 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

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RT-PCR for ERAP1 detectionReverse transcriptase -Polymerase Chain Reaction for ERAP1 detection	Diagnostic test	cases of psoriasis, normal controls

Primary outcome

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-

1 secondary outcome

Estimation of non lesional ERAP1 in psoriatic skin
Time frame: Maximum 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing RT-PCR for ERAP1 detection in people with Psoriasis, run by Kasr El Aini Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimation of lesional ERAP1 in psoriatic skin (time frame: Maximum 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03767114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.