NCT05328050

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
130mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Sep 2021Dec 2036

Study Start

First participant enrolled

September 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2036

Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

10.3 years

First QC Date

April 7, 2022

Last Update Submit

April 21, 2022

Conditions

AchondroplasiaHypochondroplasia

Outcome Measures

Primary Outcomes (1)

  • Registry of Achondroplasia and Hypochondroplasia Patients

    Collection of medical information of achondroplasia and hypochndroplasia patients intended for use in future research studies.

    10 years

Study Arms (2)

Achondroplasia

Other: Registry

Hypochondroplasia

Other: Registry

Interventions

RegistryOTHER

observational, data collection

AchondroplasiaHypochondroplasia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Genetics Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

AchondroplasiaHypochondroplasia

Interventions

Registries

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesOsteochondrodysplasiasGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Maria Francesca Bedeschi, MD

CONTACT

+390255032150mariafrancesca.bedeschi@policlinico.mi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 14, 2022

Study Start

September 1, 2021

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2036

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

IT(1)