Assessment of Serum Levels of Janus Kinase 1 and 2 in Pat... | NCT06201780

Studies
Assessment of Serum Levels of Janus Kinase 1 and 2 in Patients With Cholinergic Urticaria

NCT06201780

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jan 11, 2024Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Cholinergic Urticaria

Interventions

serum levels of Janus Kinase 1and 2

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2023Actual

Primary Completion Date

Dec 10, 2024Estimated

Completion Date

Dec 10, 2024Estimated

First Submitted Date

Jan 2, 2024

First Submission Date that Met QC Criteria

Jan 10, 2024

First Posted Date

Jan 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2024

Last Update Posted Date

Jan 11, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marwa Elsayed Mohamed, Resident-Dermatology department-sohag hospital university, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cholinergic Urticaria (CholU) is as a subtype of CIndU caused by an increase in the core body temperature, such as to activate the sweating reflex. It can occur in response to physical exercise, hot bathing and/or emotional stress. Clinically it appears as pinpointing and highly pruritic wheals with surrounding erythema, CholU can be accompanied by severe symptoms such as angioedema, respiratory symptoms or anaphylaxi CholU is frequently associated with atopic dermatitis (AD) The JAK-STAT is a mast cell (MC) signaling pathway activated downstream of IgE and IL-3 with important roles in MC homeostasis via regulation of proliferation, survival, and release of mediators. JAK-STAT activation is associated with polarization toward Th2, B cell isotype switching to IgE production, and IgE-dependent degranulation and cytokine release .

Because both IL-4 and IL-13 use the IL-4Rα as a receptor component, these cytokines activate any common signaling pathways. Both of these cytokines use Janus kinases (JAKs) to initiate signaling and activate signal transducer and activator of transcription-6 (STAT6), which is a transcription factor required for many of their biologic functions.

The non-receptor protein tyrosine kinases JAK1 and JAK3 associate with the IL-4Rα and γC, respectively. The binding of IL-4 to its receptor induces the transphosphorylation of JAK1 and JAK3, an event that activates these kinases and thereby initiates the early events of signal transduction .

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cases group	Active Comparator	group of cases with cholinergic urticaria	Diagnostic Test: serum levels of Janus Kinase 1and 2
control group	Active Comparator	control group not have cholinergic urticaria	Diagnostic Test: serum levels of Janus Kinase 1and 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
serum levels of Janus Kinase 1and 2	Diagnostic Test	assessment of serum levels of Janus Kinase 1and 2 by ELISA	cases group control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum levels of janus kinase 1	assessment of serum levels of janus kinase 1	1 year

Secondary Outcomes

Measure	Description	Time Frame
serum levels of janus kinase 2	assessment of serum levels of janus kinase 2	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The study will include 45 adult patients complaining of CholU as well as 45 healthy controls.

Exclusion Criteria:

Patients with one or more of the following criteria will be excluded:
- Pregnancy and lactation.
- Patients with systemic diseases especially those with autoimmune diseases and infections.
- Patients with skin diseases.
- Patients on medications such as: antibiotics, non-steroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, anticonvulsants, penicillin, combined oral contraceptives.
- Patient refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag university Hospital	Recruiting	Sohag			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27324252	Background	Altrichter S, Koch K, Church MK, Maurer M. Atopic predisposition in cholinergic urticaria patients and its implications. J Eur Acad Dermatol Venereol. 2016 Dec;30(12):2060-2065. doi: 10.1111/jdv.13765. Epub 2016 Jun 21.
24837213	Background	Altrichter S, Salow J, Ardelean E, Church MK, Werner A, Maurer M. Development of a standardized pulse-controlled ergometry test for diagnosing and investigating cholinergic urticaria. J Dermatol Sci. 2014 Aug;75(2):88-93. doi: 10.1016/j.jdermsci.2014.04.007. Epub 2014 May 1.

Type	Date	Date Unknown
Release	Dec 4, 2024
Reset	Jan 23, 2025