Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-01 @ 12:16 AM
Study NCT ID:
NCT05028894
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2021-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
23andMe IPF Research Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D035583', 'term': 'Rare Diseases'}, {'id': 'D022861', 'term': 'Hermanski-Pudlak Syndrome'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D016115', 'term': 'Albinism, Oculocutaneous'}, {'id': 'D000417', 'term': 'Albinism'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010981', 'term': 'Platelet Storage Pool Deficiency'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 690}, 'targetDuration': '9 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2021-08-26', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IPF Symptom Progression Baseline', 'timeFrame': 'Baseline', 'description': 'Survey asking about disease diagnosis, testing, treatments, and symptom progression'}, {'measure': 'IPF Symptom Progression 3 month follow-up', 'timeFrame': '3 months post baseline', 'description': 'IPF Symptom Progression 3 month follow-up'}, {'measure': 'IPF Symptom Progression 6 month follow-up', 'timeFrame': '6 months post baseline', 'description': 'Survey asking about disease diagnosis, testing, treatments, and symptom progression'}, {'measure': 'IPF Symptom Progression 9 month follow-up', 'timeFrame': '9 months post baseline', 'description': 'Survey asking about disease diagnosis, testing, treatments, and symptom progression'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['idiopathic pulmonary fibrosis', 'IPF', 'pulmonary fibrosis', 'lung diseases', 'lung', 'respiratory tract diseases', 'rare', 'rare diseases', 'Hermansky-Pudlak syndrome', 'HPS'], 'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'The long term goal of this study is to increase genetic understanding of IPF to enable the development of an effective drug for IPF that can improve the lives of those living with the condition.', 'detailedDescription': 'This study will recruit 1,000 people who have been diagnosed with IPF or Hermansky-Pudlak syndrome (HPS). Eligible participants who consent to participate in 23andMe Research and the IPF Research Study will receive a 23andMe Health + Ancestry kit at no cost. Participants will provide a saliva sample and take a baseline survey online answering questions about their disease diagnosis, testing, treatment, and symptoms. Participants will also be asked to take the same survey 3, 6, and 9 months after completing the baseline survey. The data collected from this study will be incorporated into the 23andMe Database and used to better understand the underlying genetic and environmental factors that contribute to IPF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will only include participants who meet the eligibility criteria as described above. Participants in the study will be diagnosed with IPF or HPS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been diagnosed with IPF or Hermansky-Pudlak syndrome (HPS)\n* Are 18+ years old\n* Live in the US\n\nExclusion Criteria:\n\n\\- Have been diagnosed with sarcoidosis or hypersensitivity pneumonitis'}, 'identificationModule': {'nctId': 'NCT05028894', 'acronym': 'IPF', 'briefTitle': '23andMe IPF Research Study', 'organization': {'class': 'INDUSTRY', 'fullName': '23andMe, Inc.'}, 'officialTitle': '23andMe Idiopathic Pulmonary Fibrosis Research Study', 'orgStudyIdInfo': {'id': '23andMe_IPF001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IPF', 'description': 'Participants diagnosed with idiopathic pulmonary fibrosis', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['IPF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94086', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'facility': '23andMe', 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}], 'overallOfficials': [{'name': 'Suyash Shringarpure', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '23andMe, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '23andMe, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}