HypospadiasNCT03838458
Molecular and Structural Comparison of Hypospadic and Normal Children Prepuces
An observational study of Hypospadias, run by Trakya University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages Up to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypospadias
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2019to 10 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: 0-18 years old pediatric male population, patients with isolated hypospadias are study group, patients with planned circumcision are control group.
Who may be able to join
- To apply for circumcision, not to have any genitourinary abnormalities/conditions for control group.
- To have isolated hypospadias for study group.
Who cannot join
- To have genitourinary surgery before.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University Faculty of Medicine
Edirne, 22030
About this study
Official title: 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.
- Conditions
- Hypospadias
- Keywords
- hypospadias, prepuce, HOXA13, FGFR2, TGF beta
- Medical subject headings
- Hypospadias, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study | Children with isolated hypospadias | |
| Control | Children with planned circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic analysis 1
Androgen receptor (AR) gene PCR analysis
Measured: 1 year
Genetic analysis 2
Estrogen receptor 1 (ER1) gene PCR analysis
Measured: 1 year
Genetic analysis 3
FGFR2 gene PCR analysis
Measured: 1 year
Genetic analysis 4
TGF beta gene PCR analysis
Measured: 1 year
Genetic analysis 5
HOXA13 gene PCR analysis
Measured: 1 year
Immunohistochemical study 1
Mucosal vessel density is planned to determine via CD34
Measured: 1 year
Immunohistochemical study 2
Mucosal nerve density is planned to determine via PGP 9.5
Measured: 1 year
Histological study 1
Laminin is planned to determine in extracellular matrix via light microscope
Measured: 1 year
Histological study 2
Collagen is planned to determine in extracellular matrix via light microscope
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start7 Jan 2019
- Primary completion7 Jan 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irem Inanc, Trakya University
- Investigators
- Dincer Avlan, Profesor, MD, Principal investigator, Trakya University Faculty of Medicine, Pediatric Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838458
- Sponsor's protocol ID
- Hypospadic prepuce structure
- Status last verified
- Apr 2020
- First submitted
- 8 Feb 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Structural and Molecular Genetic Properties Between Normal and Hypospadic Children's Prepuces
- ClinicalTrials.gov ID
- NCT03838458
- Acronym / sponsor ID
- Hypospadic prepuce structure
- Conditions
- Hypospadias
- Keywords
- hypospadias, prepuce, HOXA13, FGFR2, TGF beta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | –Children with isolated hypospadias |
| Control | – | –Children with planned circumcision |
Who may qualify
- Ages
- Up to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 0-18 years old pediatric male population, patients with isolated hypospadias are study group, patients with planned circumcision are control group.
Key inclusion criteria (2 listed)
- To apply for circumcision, not to have any genitourinary abnormalities/conditions for control group.
- To have isolated hypospadias for study group.
Key exclusion criteria (1 listed)
- To have genitourinary surgery before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic analysis 1
Time frame: 1 year
Androgen receptor (AR) gene PCR analysis
Genetic analysis 2
Time frame: 1 year
Estrogen receptor 1 (ER1) gene PCR analysis
Genetic analysis 3
Time frame: 1 year
FGFR2 gene PCR analysis
Genetic analysis 4
Time frame: 1 year
TGF beta gene PCR analysis
Genetic analysis 5
Time frame: 1 year
HOXA13 gene PCR analysis
Immunohistochemical study 1
Time frame: 1 year
Mucosal vessel density is planned to determine via CD34
Immunohistochemical study 2
Time frame: 1 year
Mucosal nerve density is planned to determine via PGP 9.5
Histological study 1
Time frame: 1 year
Laminin is planned to determine in extracellular matrix via light microscope
Histological study 2
Time frame: 1 year
Collagen is planned to determine in extracellular matrix via light microscope
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dincer Avlan, Profesor, MD principal investigator
Trakya University Faculty of Medicine, Pediatric Surgery Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypospadias, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic analysis 1 (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.