- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05328050
Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy) (OMPR-Ach/Hy)
April 21, 2022 updated by: Maria Francesca Bedeschi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Local Registry for Data Collection of Patients With Achondroplasia / Hypochondroplasia for Epidemiological, Care and Research Studies
This registry is a observational, single-center study designed to collect clinical data on patients with achondroplasia and hypochondroplasia.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maria Francesca Bedeschi, MD
- Phone Number: +390255032150
- Email: mariafrancesca.bedeschi@policlinico.mi.it
Study Locations
-
-
-
Milan, Italy, 20122
- Recruiting
- Medical Genetics Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan
-
Contact:
- Maria Francesca Bedeschi, MD
- Email: mariafrancesca.bedeschi@policlinico.mi.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients With Achondroplasia / Hypochondroplasia afferent to IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Achondroplasia
|
observational, data collection
|
Hypochondroplasia
|
observational, data collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Registry of Achondroplasia and Hypochondroplasia Patients
Time Frame: 10 years
|
Collection of medical information of achondroplasia and hypochndroplasia patients intended for use in future research studies.
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Anticipated)
December 31, 2031
Study Completion (Anticipated)
December 31, 2036
Study Registration Dates
First Submitted
April 7, 2022
First Submitted That Met QC Criteria
April 7, 2022
First Posted (Actual)
April 14, 2022
Study Record Updates
Last Update Posted (Actual)
April 28, 2022
Last Update Submitted That Met QC Criteria
April 21, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NaturalhistoryAch2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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