Molecular and Structural Comparison of Hypospadic and Normal Children Prepuces

Hypospadias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03838458
• Other study ID #: Hypospadic prepuce structure
• Status: Completed
• Start date: January 7, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: April 2020
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 10, 2020
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypospadias

Locations

Country	Name	City	State
Turkey	Trakya University Faculty of Medicine	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

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