NCT05290077

Brief Summary

Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of cardiovascular risk in patients with Vitiligo

Trial Health

43
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 not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

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

November 7, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

October 31, 2022

Status Verified

December 1, 2021

Enrollment Period

Same day

First QC Date

November 7, 2021

Last Update Submit

October 28, 2022

Conditions

Keywords

NGAL & CVR

Outcome Measures

Primary Outcomes (1)

  • serum Neutrophil Gelatinase-associated Lipocalin in patients with Vitilig

    Role of serum Neutrophil Gelatinase-associated Lipocalin in early detection of cardiovascular risk in patients with Vitiligo

    6 months

Study Arms (2)

Cases

ACTIVE COMPARATOR

group of vitiligo patients

Diagnostic Test: NGAL

control group

ACTIVE COMPARATOR

healthy group

Diagnostic Test: NGAL

Interventions

NGALDIAGNOSTIC_TEST

Serum NGAL in blood for early detection of CVR

Casescontrol group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with vitiligo above 20y

You may not qualify if:

  • patients with systemic disease Pregnants female Lactating females Patients less than 20 y Patients with active lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag fuculty

Sohag, Egypt

Location

Related Publications (4)

  • Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015 Jul 4;386(9988):74-84. doi: 10.1016/S0140-6736(14)60763-7. Epub 2015 Jan 15.

    PMID: 25596811BACKGROUND
  • Vachiramon V, Onprasert W, Harnchoowong S, Chanprapaph K. Prevalence and Clinical Characteristics of Itch in Vitiligo and Its Clinical Significance. Biomed Res Int. 2017;2017:5617838. doi: 10.1155/2017/5617838. Epub 2017 Jul 30.

    PMID: 28828385BACKGROUND
  • Silverberg JI, Silverberg NB. Association between vitiligo extent and distribution and quality-of-life impairment. JAMA Dermatol. 2013 Feb;149(2):159-64. doi: 10.1001/jamadermatol.2013.927.

    PMID: 23560296BACKGROUND
  • Mazzei Weiss ME. Vitiligo: to biopsy or not to biopsy? Cutis. 2020 Apr;105(4):189-190. No abstract available.

    PMID: 32463851BACKGROUND

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Doaa G Hafez, resident

CONTACT

Marwa M Abd El-Meged, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at dermatology department sohag university hospital

Study Record Dates

First Submitted

November 7, 2021

First Posted

March 22, 2022

Study Start

December 15, 2022

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

October 31, 2022

Record last verified: 2021-12

Locations