Creation of a Biobank of Fertile Men | NCT06189677

Studies
Creation of a Biobank of Fertile Men

NCT06189677

Sponsor

IRCCS San Raffaele

Status

Unknown status

Last Update Posted

Jan 3, 2024Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Fertility

Interventions

Observation of biological characteristics of fertile men

Countries

Italy

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2016Actual

Primary Completion Date

Jun 15, 2024Estimated

Completion Date

Jun 15, 2026Estimated

First Submitted Date

Dec 19, 2023

First Submission Date that Met QC Criteria

Dec 19, 2023

First Posted Date

Jan 3, 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

Dec 19, 2023

Last Update Posted Date

Jan 3, 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

Collection and conservation of human biological material from fertile subjects, i.e. men with previous parenthood (normospermic men, natural fathers).

Detailed Description

The project aims to collect biological material derived both from surgical resections of the most common urological tumors and from peripheral blood or other biological fluids such as urine or seminal fluid when available. The objective of the study is to establish a biobank of human biological material, which will allow access to samples of extreme value for the pathophysiological study of the tumor, its origin, mechanisms and markers of progression, as well as the creation of this collection it will represent an extremely valuable tool for the study of individual response to therapies.

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

Retention

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation of biological characteristics of fertile men	Other	Sampling in outpatient settings, after biopsy or after surgery and collection of biological samples in fertile subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prognostic role of the biological material	Biological signature in fertile men predicting potential therapeutic, prognostic and diagnostic biomarkers	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normospermic male individuals
Naturally fertile male individuals
Male individuals > 18 years

Exclusion Criteria:

Non-normospermic male individuals
Male individuals who are not naturally fertile
Male individuals < 18 years

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Normospermic male individuals, naturally fertile men recruited on an outpatient and day-hospital basis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Ospedale San Raffaele	Recruiting	Milan	Lombardy	20132	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided