AchondroplasiaOMPR-Ach/HyNCT05328050
Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy)
An observational study of Achondroplasia and Hypochondroplasia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
This registry is a observational, single-center study designed to collect clinical data on patients with achondroplasia and hypochondroplasia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Achondroplasia, Hypochondroplasia
- What is being tested?
- Registry
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 31 Dec 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients With Achondroplasia / Hypochondroplasia afferent to IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
Who may be able to join
- Confirmed diagnosis of achondroplasia/hypochondroplasia
- Patients (and/or Parents legal guardian when required) able to provide informed consent
Who cannot join
- Absence of diagnosis of achondroplasia/hypochondroplasia
- Patients (and/or Parents legal guardian when required) not able to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Medical Genetics Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan
Milan, 20122
Maria Francesca Bedeschi, MD, mariafrancesca.bedeschi@policlinico.mi.it
About this study
Official title: 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.
- Conditions
- Achondroplasia, Hypochondroplasia
- Being tested
- Registry
- Medical subject headings
- Achondroplasia, Hypochondroplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
observational, data collection
| Study group | Role | What they receive |
|---|---|---|
| Achondroplasia | Not described Receives: Other: Registry | |
| Hypochondroplasia | Not described Receives: Other: Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registry of Achondroplasia and Hypochondroplasia Patients
Collection of medical information of achondroplasia and hypochndroplasia patients intended for use in future research studies.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Sep 2021
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchondroplasiaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Francesca Bedeschi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328050
- Sponsor's protocol ID
- NaturalhistoryAch2021
- Acronym
- OMPR-Ach/Hy
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Registry for Data Collection of Patients With Achondroplasia / Hypochondroplasia for Epidemiological, Care and Research Studies
- ClinicalTrials.gov ID
- NCT05328050
- Acronym / sponsor ID
- OMPR-Ach/Hy / NaturalhistoryAch2021
- Conditions
- Achondroplasia, Hypochondroplasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This registry is a observational, single-center study designed to collect clinical data on patients with achondroplasia and hypochondroplasia.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Achondroplasia | – | Other: Registry |
| Hypochondroplasia | – | Other: Registry |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients With Achondroplasia / Hypochondroplasia afferent to IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
Key inclusion criteria (2 listed)
- Confirmed diagnosis of achondroplasia/hypochondroplasia
- Patients (and/or Parents legal guardian when required) able to provide informed consent
Key exclusion criteria (2 listed)
- Absence of diagnosis of achondroplasia/hypochondroplasia
- Patients (and/or Parents legal guardian when required) not able to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Registryobservational, data collection | Other | Achondroplasia, Hypochondroplasia |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achondroplasia and Hypochondroplasia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Francesca Bedeschi, MD (+390255032150, mariafrancesca.bedeschi@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registry of Achondroplasia and Hypochondroplasia Patients (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.