Metachronous Acquired Contralateral Cryptorchidism in Pat... | NCT06533306

Studies
Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.

NCT06533306

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Status

Completed

Last Update Posted

Aug 1, 2024Actual

Enrollment

126Actual

Phase

Not provided

Conditions

Cryptorchidism

Interventions

Surgery for cryptorchidism.

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Actual

Primary Completion Date

May 30, 2024Actual

Completion Date

May 30, 2024Actual

First Submitted Date

Jul 25, 2024

First Submission Date that Met QC Criteria

Jul 29, 2024

First Posted Date

Aug 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2024

Last Update Posted Date

Aug 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study aims to calculate the risk of a patient with a history of cryptorchidism developing cryptorchidism on the contralateral side.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery for cryptorchidism.	Procedure	Patients previously operated on for cryptorchidism.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Contralateral Cryptorchidism	Proportion of patients previously operated on for cryptorchidism in whom acquired contralateral cryptorchidism is detected.	Up to 1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 13 years or older, previously operated on for cryptorchidism.

Exclusion Criteria:

Diagnosis of endocrine disease or any polymalformative syndrome.
Synchronous bilateral cryptorchidism.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients previously operated on for cryptorchidism

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carme Grande Moreillo, MD	CSAPG	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Consorci Sanitari Alt Penedès-Garraf		Vilafranca del Penedès	Barcelona	08720	Spain

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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).

Types

Study Protocol

Time Frame

After publication of main results of the study.

Access Criteria

IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003456	Cryptorchidism

Ancestor Terms

ID	Term
D013733	Testicular Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided