Molecular and Structural Comparison of Hypospadic and Normal Children Prepuces

Comparison of Structural and Molecular Genetic Properties Between Normal and Hypospadic Children's Prepuces

The aim of this study is to compare prepuce tissue samples from healthy male children who applied for circumcision and children with isolated hypospadias. Estrogen receptor 1 (ER1), androgen receptor (AR), FGFR2, transforming growth factor beta (TGF beta) and HOXA13 gene expression in the prepuce is planned to investigate via polymerase chain reaction (PCR) method. Mucosal vascular and nerve densities, and extracellular matrix density of laminin and collagen protein is planned to investigate via immunohistochemical examination.

Study Overview

• Status: Completed
• Conditions: Hypospadias

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Turkey
  • Edirne, Turkey, 22030
    • Trakya University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

0-18 years old pediatric male population, patients with isolated hypospadias are study group, patients with planned circumcision are control group.

Description

Inclusion Criteria:

• To apply for circumcision, not to have any genitourinary abnormalities/conditions for control group.
• To have isolated hypospadias for study group.

Exclusion Criteria:

• To have genitourinary surgery before.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Study; Children with isolated hypospadias
Control; Children with planned circumcision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic analysis 1	Androgen receptor (AR) gene PCR analysis	1 year
Genetic analysis 2	Estrogen receptor 1 (ER1) gene PCR analysis	1 year
Genetic analysis 3	FGFR2 gene PCR analysis	1 year
Genetic analysis 4	TGF beta gene PCR analysis	1 year
Genetic analysis 5	HOXA13 gene PCR analysis	1 year
Immunohistochemical study 1	Mucosal vessel density is planned to determine via CD34	1 year
Immunohistochemical study 2	Mucosal nerve density is planned to determine via PGP 9.5	1 year
Histological study 1	Laminin is planned to determine in extracellular matrix via light microscope	1 year
Histological study 2	Collagen is planned to determine in extracellular matrix via light microscope	1 year

Collaborators and Investigators

• Sponsor: Trakya University
• Investigators: Principal Investigator: Dincer Avlan, Profesor, MD, Trakya University Faculty of Medicine, Pediatric Surgery Department

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): January 7, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 9, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 25, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: hypospadias; FGFR2; TGF beta; prepuce; HOXA13
• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Hypospadias
• Other Study ID Numbers: Hypospadic prepuce structure

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No