Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-28 @ 10:15 PM
Study NCT ID:
NCT05328050
Status:
RECRUITING
Last Update Posted:
2022-04-28
First Post:
2022-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000130', 'term': 'Achondroplasia'}, {'id': 'C562937', 'term': 'Hypochondroplasia'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012042', 'term': 'Registries'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2036-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Registry of Achondroplasia and Hypochondroplasia Patients', 'timeFrame': '10 years', 'description': 'Collection of medical information of achondroplasia and hypochndroplasia patients intended for use in future research studies.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Achondroplasia', 'Hypochondroplasia']}, 'descriptionModule': {'briefSummary': 'This registry is a observational, single-center study designed to collect clinical data on patients with achondroplasia and hypochondroplasia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients With Achondroplasia / Hypochondroplasia afferent to IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of achondroplasia/hypochondroplasia\n* Patients (and/or Parents legal guardian when required) able to provide informed consent\n\nExclusion Criteria:\n\n* Absence of diagnosis of achondroplasia/hypochondroplasia\n* Patients (and/or Parents legal guardian when required) not able to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05328050', 'acronym': 'OMPR-Ach/Hy', 'briefTitle': 'Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy)', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Local Registry for Data Collection of Patients With Achondroplasia / Hypochondroplasia for Epidemiological, Care and Research Studies', 'orgStudyIdInfo': {'id': 'NaturalhistoryAch2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Achondroplasia', 'interventionNames': ['Other: Registry']}, {'label': 'Hypochondroplasia', 'interventionNames': ['Other: Registry']}], 'interventions': [{'name': 'Registry', 'type': 'OTHER', 'description': 'observational, data collection', 'armGroupLabels': ['Achondroplasia', 'Hypochondroplasia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Francesca Bedeschi, MD', 'role': 'CONTACT', 'email': 'mariafrancesca.bedeschi@policlinico.mi.it'}], 'facility': "Medical Genetics Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Maria Francesca Bedeschi, MD', 'role': 'CONTACT', 'email': 'mariafrancesca.bedeschi@policlinico.mi.it', 'phone': '+390255032150'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Maria Francesca Bedeschi', 'investigatorAffiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}}}}