NCT03303508

Brief Summary

detection of anti-ds DNA in patients with rheumatic diseases by two methodes : immunofluorescence \& ELISA

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

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 27, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 6, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

September 27, 2017

Last Update Submit

October 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison Between Immunofluorescence and Enzyme Immunoassay

    Verfication of the anti-dsDNA examination methods used in the Laboratory of Clinical Immunology, Assiut University Hospital.

    one year

Secondary Outcomes (1)

  • Detection of Anti-Double Stranded Deoxyribonucleic Acid Antibodies in Autoimmune Rheumatic Diseases

    one year

Study Arms (1)

anti-ds DNA

OTHER

anti-ds DNA

Diagnostic Test: anti-ds DNA

Interventions

anti-ds DNADIAGNOSTIC_TEST

venous blood samples

Also known as: venous blood samples
anti-ds DNA

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study will include patients with suspected diagnosis of autoimmune rheumatic diseases referred to the Laboratory of Clinical Immunology, Clinical Pathology Department, Assiut University Hospital for anti-dsDNA test. Patients will be recruited into the study within period of one year.
  • Also, apparently healthy subjects (at least 25 subjects; according to international method verification guidelines) will be included as a control group

You may not qualify if:

  • Subjects refused to be included in the study. Patients without a definite diagnosis of autoimmune rheumatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bai Y, Tong Y, Liu Y, Hu H. Self-dsDNA in the pathogenesis of systemic lupus erythematosus. Clin Exp Immunol. 2018 Jan;191(1):1-10. doi: 10.1111/cei.13041. Epub 2017 Sep 15.

    PMID: 28836661BACKGROUND

MeSH Terms

Conditions

Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: The study will include patients with suspected diagnosis of autoimmune rheumatic diseases referred to the Laboratory of Clinical Immunology, Clinical Pathology Department, Assiut University Hospital for anti-dsDNA test. Patients will be recruited into the study within period of one year. Also, apparently healthy subjects (at least 25 subjects; according to international method verification guidelines) will be included as a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Detection of Anti-Double Stranded Deoxyribonucleic Acid Antibodies in Autoimmune Rheumatic Diseases

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 6, 2017

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

October 6, 2017

Record last verified: 2017-09