NCT04284878

Brief Summary

This study aims:

  1. 1.To investigate the association between single nucleotide polymorphisms of PTPN22 gene (rs2476601, rs33996649 and rs2488457) and inflammatory bowel disease.
  2. 2.To correlate the relation between the studied SNPs and disease activity /response to therapy.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

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

February 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

February 23, 2020

Last Update Submit

February 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Association between single nucleotide polymorphisms of Lymphoid Tyrosine Phosphatase gene (rs2476601, rs33996649 and rs2488457) and inflammatory bowel disease

    Three single nucleotide polymorphisms in the lymphoid tyrosine phosphatase gene(SNP (G788\>A) in exon10, SNP (C1858\>T) in exon 14 and SNP (G -1123\>C) in the promoter region ) will be assessed in 100 patients diagnosed as inflammatory bowel disease and 100 healthy subjects by Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) to detect association between these polymorphisms and inflammatory bowel disease

    baseline

Secondary Outcomes (1)

  • To correlate the relation between the studied SNPs and disease activity /response to therapy.

    baseline

Study Arms (2)

A

patients with inflammatory bowel disease

Genetic: PCR-RFLP

B

healthy subjects

Genetic: PCR-RFLP

Interventions

PCR-RFLPGENETIC

PCR-Restriction fragment length polymorphism

AB

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

IBD Patients will Diagnosed according to established guidelines for UC/CD . Phenotype characteristics of UC and CD were defined according to the Montreal classification . The clinical disease activity will be assessed using the Montreal classification of UC disease activity and Crohn's Disease Activity Index (CDAI) for CD

You may qualify if:

  • patients with inflammatory bowel disease

You may not qualify if:

  • Patients with systemic autoimmune diseases (RA,SLE) will be excluded from the study .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Norouzinia M, Chaleshi V, Alizadeh AHM, Zali MR. Biomarkers in inflammatory bowel diseases: insight into diagnosis, prognosis and treatment. Gastroenterol Hepatol Bed Bench. 2017 Summer;10(3):155-167.

    PMID: 29118930BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

gene polymorphisms

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

menna refaat, Ass lecturer

CONTACT

eman reda, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

February 23, 2020

First Posted

February 26, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2021

Study Completion

September 1, 2021

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share