Registry for Patients With Achondroplasia / Hypochondropl... | NCT05328050

Studies
Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy)

NCT05328050

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Status

Recruiting

Last Update Posted

Apr 28, 2022Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Achondroplasia
Hypochondroplasia

Interventions

Registry

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

Apr 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Dec 31, 2031Estimated

Completion Date

Dec 31, 2036Estimated

First Submitted Date

Apr 7, 2022

First Submission Date that Met QC Criteria

Apr 7, 2022

First Posted Date

Apr 14, 2022Actual

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

Apr 21, 2022

Last Update Posted Date

Apr 28, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Francesca Bedeschi, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoPrincipal Investigator

Lead Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This registry is a observational, single-center study designed to collect clinical data on patients with achondroplasia and hypochondroplasia.

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

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Achondroplasia			Other: Registry
Hypochondroplasia			Other: Registry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Registry	Other	observational, data collection	Achondroplasia Hypochondroplasia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Registry of Achondroplasia and Hypochondroplasia Patients	Collection of medical information of achondroplasia and hypochndroplasia patients intended for use in future research studies.	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of achondroplasia/hypochondroplasia
Patients (and/or Parents legal guardian when required) able to provide informed consent

Exclusion Criteria:

Absence of diagnosis of achondroplasia/hypochondroplasia
Patients (and/or Parents legal guardian when required) not able to provide informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients With Achondroplasia / Hypochondroplasia afferent to IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maria Francesca Bedeschi, MD	Contact	+390255032150		mariafrancesca.bedeschi@policlinico.mi.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Genetics Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan	Recruiting	Milan		20122	Italy

Condition Browse Module

MeSH Terms

ID	Term
D000130	Achondroplasia
C562937	Hypochondroplasia

Ancestor Terms

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012042	Registries

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D011996	Records

Browse Leaves

Not provided

Browse Branches

Not provided