NCT04100876

Brief Summary

  • To compare global DNA methylation status between ITP patients and healthy subjects .
  • To determine the effect of DNMT3A -448 G/A SNP variant A allele and DNMT3B -149C/T SNP variant T-allele on global DNA methylation in both ITP patients and healthy control subjects.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

September 23, 2019

Last Update Submit

September 23, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of global DNA methylation status between ITP patients and healthy subjects .

    To understand the underlying mechanism behind the association of DNMT3A -448 G/A SNP variant A allele with decreased risk of primary ITP and DNMT3B -149C/T SNP variant T-allele with increased risk of primary ITP which was observed in a previous study in Assiut University Hospital (AbdelKader et al., 2018).

    baseline .

Study Arms (2)

primary ITP patients .

60 primary ITP patients .

Genetic: Global DNA methylation will be quantified in the DNA samples by colorimetry

healthy subjects .

30 healthy age and sex matched control subjects .

Genetic: Global DNA methylation will be quantified in the DNA samples by colorimetry

Interventions

Global DNA methylation will be quantified in the DNA samples by colorimetry

healthy subjects .primary ITP patients .

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

: 60 primary ITP patient and 30 healthy age and sex matched control subjects .

You may qualify if:

  • Egyptian patients with isolated thrombocytopenia, no organomegaly or lymphoadenopathy, no constitutional symptoms (bone pains, weight loss, and night sweats) and no history of preceding drug intake (quinine, heparin) .

You may not qualify if:

  • Conditions/diseases associated with secondary ITP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Study will be conducted on DNA samples (available from previous study of AbdelKader et al., 2018) with known DNMT3A -448 G/A and DNMT3B -149C/T genotypes.

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Heba A Abdel-Hafeez, Professor

    Clinical Pathology Department in Assuit University Hospital

    STUDY DIRECTOR

Central Study Contacts

Mennat-Allah A Mahmoud, physician

CONTACT

Tarek TH ElMelegy, Lecturer

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 24, 2019

Study Start

December 1, 2019

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

September 24, 2019

Record last verified: 2019-09