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Molecular and Structural Comparison of Hypospadic and Normal Children Prepuces

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03838458
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : April 11, 2019
Information provided by (Responsible Party):
Irem Inanc, Trakya University

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.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparison of Structural and Molecular Genetic Properties Between Normal and Hypospadic Children's Prepuces
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

Children with isolated hypospadias
Children with planned circumcision

Primary Outcome Measures :
  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

Biospecimen Retention:   Samples With DNA
Preputial tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03838458

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Contact: Irem Inanc, MD +902842357641 ext 2950
Contact: Dincer Avlan, Profesor, MD

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Trakya University Faculty of Medicine Recruiting
Edirne, Turkey, 22030
Contact: Irem Inanc, MD    +905436204929   
Sponsors and Collaborators
Trakya University
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Principal Investigator: Dincer Avlan, Profesor, MD Trakya University Faculty of Medicine, Pediatric Surgery Department

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Responsible Party: Irem Inanc, MD, Trakya University Identifier: NCT03838458     History of Changes
Other Study ID Numbers: 1070401045
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Irem Inanc, Trakya University:
TGF beta
Additional relevant MeSH terms:
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Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities