Skip to main content
OpenTrials
Completed

NCT Number: NCT03838458

Molecular and Structural Comparison of Hypospadic and Normal Children 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypospadias Bone Diseases Bone Diseases, Developmental Camurati-Engelmann Syndrome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Male Male Urogenital Diseases Musculoskeletal Diseases Osteochondrodysplasias Penile Diseases Urogenital Abnormalities Urogenital Diseases

Age range

Up to 18 year

Sex eligibility

Male

Study type

Observational

Primary location

Trakya University Faculty of Medicine

Edirne, 22030, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Genetic analysis 1

    Time frame: 1 year

    Androgen receptor (AR) gene PCR analysis

  2. Genetic analysis 2

    Time frame: 1 year

    Estrogen receptor 1 (ER1) gene PCR analysis

  3. Genetic analysis 3

    Time frame: 1 year

    FGFR2 gene PCR analysis

  4. Genetic analysis 4

    Time frame: 1 year

    TGF beta gene PCR analysis

  5. Genetic analysis 5

    Time frame: 1 year

    HOXA13 gene PCR analysis

  6. Immunohistochemical study 1

    Time frame: 1 year

    Mucosal vessel density is planned to determine via CD34

  7. Immunohistochemical study 2

    Time frame: 1 year

    Mucosal nerve density is planned to determine via PGP 9.5

  8. Histological study 1

    Time frame: 1 year

    Laminin is planned to determine in extracellular matrix via light microscope

  9. Histological study 2

    Time frame: 1 year

    Collagen is planned to determine in extracellular matrix via light microscope

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 12, 2019
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.