NCT04375852

Brief Summary

Tyrosine hydroxylase autoantibodies impair sympathetic innervation leading to keratitis. In this study, the investigators have shown the significant association between severity of keratitis and presence of tyrosine hydroxylase autoantibodies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Status
completed

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

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2014

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

April 26, 2020

Last Update Submit

May 2, 2020

Conditions

Autoimmune Polyglandular Syndrome Type IAutoimmune Keratitis

Keywords

Tyrosine hydroxylaseAutoantibodiesAutoimmune Polyglandular Syndrome

Outcome Measures

Primary Outcomes (1)

  • To report the correlation between autoantibodies with the severity keratitis in patients Autoimmune polyglandular syndrome type 1 (APS-1).

    Blood was obtained from each patient for determination of a panel of autoantibodies to the following: Side-chain cleavage enzyme (SSC), Aromatic L-amino acid decarboxylase (AADC), Tryptophan hydroxylase (TPH),Tyrosine hydroxylase ( TH), 17α-hydroxylase (17α-OH), Cytochrome P450 1A2 (CYP1A2), 21-hydroxylase (21-OH), Potassium channel regulatory protein (KCNRG), Tyrosine phosphatase-like protein IA-2 (IA-2), Glutamic acid decarboxylase 65 (GAD65), NACT Leucine-Rich-Repeat-Protein 5 (NALP5), and Interleukin (IL) 22.

    3 months

Study Arms (1)

1

EXPERIMENTAL

consecutive cases diagnosed with APS-1associated keratitis

Diagnostic Test: Detection of autoantibodies

Interventions

Detection of autoantibodiesDIAGNOSTIC_TEST

Blood was obtained from each patient for testing the endocrine functions and determination of a panel of autoantibodies to the following: Side-chain cleavage enzyme (SSC), Aromatic L-amino acid decarboxylase (AADC), Tryptophan hydroxylase (TPH),Tyrosine hydroxylase ( TH), 17α-hydroxylase (17α-OH), Cytochrome P450 1A2 (CYP1A2), 21-hydroxylase (21-OH), Potassium channel regulatory protein (KCNRG), Tyrosine phosphatase-like protein IA-2 (IA-2), Glutamic acid decarboxylase 65 (GAD65), NACT Leucine-Rich-Repeat-Protein 5 (NALP5), and Interleukin (IL) 22.

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • consecutive patients diagnosed with APS-1associated keratitis

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polyendocrinopathies, Autoimmune

Condition Hierarchy (Ancestors)

Endocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2020

First Posted

May 5, 2020

Study Start

January 1, 2014

Primary Completion

June 6, 2014

Study Completion

June 6, 2014

Last Updated

May 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share