Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 7:06 AM
Study NCT ID:
NCT05817734
Status:
RECRUITING
Last Update Posted:
2024-07-16
First Post:
2023-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Phenotype Project Study Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and stool sampls'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2045-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-14', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-04-16', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2045-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adult disease', 'timeFrame': '25 years', 'description': "Development of medical conditions based on participant's self-reporting coded to ICD11."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adult Disease']}, 'referencesModule': {'references': [{'pmid': '39501340', 'type': 'DERIVED', 'citation': 'Rein M, Elkan M, Godneva A, Dolev NC, Segal E. Sex-specific dietary habits and their association with weight change in healthy adults. BMC Med. 2024 Nov 6;22(1):512. doi: 10.1186/s12916-024-03730-3.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective study aimed at recruiting 30,000 individuals, aged 40-70 years old, and following them longitudinally for 25 years with repeated measurements. The basic follow-up frame will include a visit to the Clinical Test Center (CTC) every two years and a phone interview every other year (on uneven years). Sample collection and biobanking will be performed every two years and online questionnaires will be filled out on an annual basis.\n\nThe primary goals are to study the variation observed across different individuals in disease susceptibility, clinical phenotypes, and therapeutic responses. The study aims at studying the complex interplay and relative contribution of different omics, physiological characteristics and lifestyle on disease pathogenesis and progression and to evaluate how these effects are mediated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General volunteering population who can freely register for the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18+, males and females.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Mentally disabled or in general legally non-competent.\n* Prisoner or soldier. Soldiers: mandatory service only\n* Active cancer\n* Fertility Treatments (current)\n* Hepatitis ( B, C), chronic or acute\n* HIV\n* Liver cirrhosis\n* Dialysis\n* Unstable medical conditions'}, 'identificationModule': {'nctId': 'NCT05817734', 'briefTitle': 'Human Phenotype Project Study Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Weizmann Institute of Science'}, 'officialTitle': 'Longitudinal Collection of Observational Clinical and Lifestyle Data', 'orgStudyIdInfo': {'id': '1789-1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Rehovot', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Hila Saranga, Msc', 'role': 'CONTACT', 'email': 'hilasa@weizmann.ac.il', 'phone': '972-8-9343266'}], 'facility': 'Weizmann institute of science', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}], 'centralContacts': [{'name': 'Eran Segal, Prof.', 'role': 'CONTACT', 'email': 'Eran.Segal@weizmann.ac.il', 'phone': '972-8-9343266'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weizmann Institute of Science', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Eran Segal, PI at the department of computer science and applied math', 'investigatorFullName': 'Eran Segal', 'investigatorAffiliation': 'Weizmann Institute of Science'}}}}