Molecular and Structural Comparison of Hypospadic and Normal Children Prepuces

NCT03838458 | Completed

• 1 other identifier: Hypospadic prepuce structure
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypospadias

Keywords

hypospadias; prepuce; HOXA13; FGFR2; TGF beta

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Study

Children with isolated hypospadias

Control

Children with planned circumcision

Eligibility Criteria

• Age: Up to 18 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• To have genitourinary surgery before.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Faculty of Medicine

Edirne, 22030, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Preputial tissue

MeSH Terms

Conditions

Hypospadias; Camurati-Engelmann Syndrome

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn

Study Officials

• Dincer Avlan, Profesor, MD

  Trakya University Faculty of Medicine, Pediatric Surgery Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 12, 2019
• Study Start: January 7, 2019
• Primary Completion: January 7, 2020
• Study Completion: March 10, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

TU (1)