Prospective Observational Study and Biobank CKIO | NCT04440722

Studies
Prospective Observational Study and Biobank CKIO

NCT04440722

Sponsor

Odense University Hospital

Status

Suspended

Last Update Posted

Mar 21, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Transgender

Interventions

Not provided

Countries

Denmark

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

replaced by other study

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Aug 1, 2040Estimated

Completion Date

Aug 1, 2040Estimated

First Submitted Date

Jun 11, 2020

First Submission Date that Met QC Criteria

Jun 18, 2020

First Posted Date

Jun 22, 2020Actual

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

Mar 18, 2025

Last Update Posted Date

Mar 21, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marianne Andersen, Consultat, Dr Med, professor, Odense University HospitalPrincipal Investigator

Lead Sponsor

Odense University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective observational study and biobank in all persons referred to CKIO

Patient involvement and quality of life
Population characteristics regarding hormone levels, safety parameters and clinical outcome before and after gender affirming hormone treatment.

Detailed Description

This is a prospective observational cohort study including all patients referred to the Center of Gender Identity Odense. The purpose is to follow patients yearly to observe patient reported outcomes and control the quality and effects of the clinical treatment.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transgender individuals		All transgender individuals referred to center of gender identity Odense

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient reported outcomes (PRO)	Questionnaires	Every 52 weeks
Hormone levels	Blood samples	Every 52 weeks
Safety parameters	Blood samples	Every 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure	Blood pressure measured in a sitting position	Every 52 weeks
Body mass index	Body mass index calculated from height an weight

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All Individuals with gender dysforia who are referred to Center of Gender Identity Odense
Age 18+

Exclusion Criteria:

°There are no exclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients referred til CKIO

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marianne Andersen, Professor	Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, Odense University Hospital		Odense		5000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided