Mannose Binding Lectin Gene Polymorphism Versus Microbial... | NCT04552210

Studies
Mannose Binding Lectin Gene Polymorphism Versus Microbial Virulence in the Pathogenesis of Vulvovaginal Candidiasis

NCT04552210

Sponsor

Aljazeera Hospital

Status

Unknown status

Last Update Posted

Nov 10, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Infection

Interventions

blood sample

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

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

Sep 16, 2020Actual

Primary Completion Date

Dec 15, 2020Estimated

Completion Date

Feb 20, 2021Estimated

First Submitted Date

Sep 11, 2020

First Submission Date that Met QC Criteria

Sep 11, 2020

First Posted Date

Sep 17, 2020Actual

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

Nov 7, 2020

Last Update Posted Date

Nov 10, 2020Actual

Name	Class
Cairo University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The vaginal mucosa is inhabited by both fungal and bacterial microorganisms which normally co-exist with the host in a tightly regulated and commensal manner.

Detailed Description

Nevertheless, under certain circumstances, this co-existence can turn into a pathologic state followed by symptomatic disease

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sample	Diagnostic Test	Whole blood was collected on EDTA (1mg/ml) to prevent clotting and DNA degradation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the number of women who have mutation in MBL2 gene polymorphism	women who have mutation in MBL2 gene polymorphism	a month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Married females in the reproductive age period. 2. Females complaining of vaginal discharge (whitish and scanty), itching, dyspareunia, pruritis, and signs of vulvovaginitis ie. erythema.

Exclusion Criteria:

females who attended the same clinic in the same period, matched the cases regarding the age group, without having Candida infection as confirmed by culture of vaginal swabs.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

female with candidal infection

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Married females in the reproductive age period. 2. Females complaining of vaginal discharge (whitish and scanty), itching, dyspareunia, pruritis, and signs of vulvovaginitis ie. erythema.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Alalfy	Contact	01002611058		mahmoudalalfy@ymail.com
Ahmed Elgazzar	Contact	01014005959		elgazzara50@gmail.com

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy	Algezeera hospitaland National Research Centre ,Egypt	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah	Recruiting	Giza			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Detection of MBL2 single nucleotide polymorphisms (SNPs):

The three SNPs in the promoter regions; rs11003125 (L/H), rs7096206 (Y/X), rs7095891 (P/Q), and one SNP rs1800450 (Gly54Asp) present in codon 54 of MBL2 were genotyped using ARMS-PCR (amplification refractory mutation system- PCR)