CryptorchidismNCT06533306
Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.
An observational study of Cryptorchidism, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial summary
The present study aims to calculate the risk of a patient with a history of cryptorchidism developing cryptorchidism on the contralateral side. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Cryptorchidism
- What is being tested?
- Surgery for cryptorchidism.
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2024to 30 May 2024
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients previously operated on for cryptorchidism
Who may be able to join
- Patients aged 13 years or older, previously operated on for cryptorchidism.
Who cannot join
- Diagnosis of endocrine disease or any polymalformative syndrome.
- Synchronous bilateral cryptorchidism.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Consorci Sanitari Alt Penedès-Garraf
Vilafranca del Penedès, Barcelona, 08720
About this study
Official title: Estimation of the Risk of Presenting Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.
The present study aims to calculate the risk of a patient with a history of cryptorchidism developing cryptorchidism on the contralateral side.
- Conditions
- Cryptorchidism
- Being tested
- Surgery for cryptorchidism.
- Keywords
- Cryptorchidism
- Medical subject headings
- Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for cryptorchidism.Procedure or surgery
Patients previously operated on for cryptorchidism.
What is being measured
The primary outcome is the main question the study is designed to answer.
Contralateral Cryptorchidism
Proportion of patients previously operated on for cryptorchidism in whom acquired contralateral cryptorchidism is detected.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Apr 2024
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryptorchidismStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carme Grande Moreillo, MD, Principal investigator, CSAPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533306
- Sponsor's protocol ID
- CSAPG-63
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Risk of Presenting Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.
- ClinicalTrials.gov ID
- NCT06533306
- Acronym / sponsor ID
- CSAPG-63
- Conditions
- Cryptorchidism
- Keywords
- Cryptorchidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 1 Aug 2024 (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 present study aims to calculate the risk of a patient with a history of cryptorchidism developing cryptorchidism on the contralateral side.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients previously operated on for cryptorchidism
Key inclusion criteria (1 listed)
- Patients aged 13 years or older, previously operated on for cryptorchidism.
Key exclusion criteria (2 listed)
- Diagnosis of endocrine disease or any polymalformative syndrome.
- Synchronous bilateral cryptorchidism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for cryptorchidism.Patients previously operated on for cryptorchidism. | Procedure or surgery | – |
Primary outcome
Contralateral Cryptorchidism
Time frame: Up to 1 month
Proportion of patients previously operated on for cryptorchidism in whom acquired contralateral cryptorchidism is detected.
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 1 Aug 2024.
- Individual participant dataSharing planned: Yes. IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
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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.
Carme Grande Moreillo, MD principal investigator
CSAPG
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 Cryptorchidism, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
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 1 inclusion and 2 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 1 Aug 2024. 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 Spain. 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?
Contralateral Cryptorchidism (time frame: Up to 1 month). 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 1 Aug 2024.