Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT04834518
Status:
RECRUITING
Last Update Posted:
2024-10-17
First Post:
2021-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2021-04-04', 'studyFirstSubmitQcDate': '2021-04-04', 'lastUpdatePostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of presymptomatic type 1 diabetes', 'timeFrame': 'End of screening and follow-up period-4 years after obtaining the first screening test', 'description': 'Presymptomatic type 1 diabetes, defined as positive for 2 or more islet autoantibodies (GADA, IA-2A, and IAA) or those with high levels of a single antibody in both the screening and confirmation samples or in the screening sample plus a diagnosis of diabetes prior to obtaining the conformation sample.\n\nPresymptomatic type 1 diabetes will be classified as stage 1, 2, or 3:\n\n* Stage 1 will be defined as 2 or more islet autoantibodies or high levels of a single antibody and normal glucose tolerance based on OGTT results. (not including patients with only a single antibody who have first degree relative with type 1 diabetes)\n* Stage 2 will be defined as 1 or more islet autoantibodies accompanied by dysglycemia (fasting plasma glucose of 110-125 mg/dL or impaired 2-hour plasma glucose of 140- 199 mg/dL and/or plasma glucose ≥200 mg/dL at intermediate time points \\[30, 60, 90 minutes\\]) based on OGTT results.\n* Stage 3 will be defined according to the American Diabetes Association criteria'}, {'measure': 'Frequency of Diabetic Ketoacidosis on the clinical presentation of Type 1 Diabetes', 'timeFrame': 'End of screening and follow-up period-4 years after obtaining the first screening test'}], 'secondaryOutcomes': [{'measure': 'The average age of islet autoantibody seroconversion', 'timeFrame': 'End of screening and follow-up period-4 years after obtaining the first screening test'}, {'measure': 'The rate of islet autoantibody seroconversion', 'timeFrame': 'End of screening and follow-up period-4 years after obtaining the first screening test'}, {'measure': 'The rate of progression from pre-symptomatic T1D to clinical diabetes', 'timeFrame': 'End of screening and follow-up period-4 years after obtaining the first screening test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autoantibodies screening'], 'conditions': ['Type1diabetes']}, 'descriptionModule': {'briefSummary': "A national screening program for children aged 9 months-5 years that will be tested for the presence of islet autoantibodies.Up to 50,000 Children will be screened by their primary care physician all over Israel. The initial screening will be done at the age of 1 year (in conjunction with the routinely collection of blood for CBC ) and repeated at ages 2-5 years. Antibodies will be measured in capillary blood samples using the Ultrasensitive Antibody Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods. By using this innovative technology in such a large cohort, the study is anticipated to detect antibodies at an unprecedented earlier age.When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology. In addition, multiple antibodies will be also measured using a radio-binding assay (RBA) of a venous blood sample for investigational purpose only. Children with confirmed multiple antibodies (stage 1 or 2 T1D) will be followed up routinely for the appearance of clinical signs of diabetes (HbA1c, repeated OGTT, monitoring of urine and blood glucose where indicated) and will be invited along with their families to attend an educational program. This program will include diabetes education emphasizing on DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. The analysis and storage of the samples will be done in a single screening center at Schneider Children's Medical Center of Israel."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '9 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children from the general population of all over Israel, aged 9 months-5 years arriving to the routine blood test for CBC or to any other routine visit to the community pediatrician.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities\n* Children aged 9-months- 5 years at first screening.\n\nExclusion Criteria:\n\n* Known diagnosis of diabetes (Type 1 or other)'}, 'identificationModule': {'nctId': 'NCT04834518', 'acronym': 'ADIR', 'briefTitle': 'Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '018620RMC & 18420COM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Negative result at the first autoantibodies screening test', 'description': 'Participants will be invited to repeat the screening test at the age of 2-5 years old'}, {'label': 'Positive result at the first or second autoantibodies screening test', 'description': '* Participants will be monitored annually for risk of type 1 diabetes. (HbA1c, repeated OGTT, monitoring of urine and blood glucose where indicated)\n* Families will attend diabetes-educational program emphasizing on DKA prevention\n* Stress assessment for the families involved and stress alleviating interventions when required.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Eli Hershkovitz, Prof', 'role': 'CONTACT', 'email': 'EliH@clalit.org.il'}, {'name': 'Eli Hershkovitz, Prof', 'role': 'CONTACT'}], 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Haifa', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Naim Shehadeh, Prof', 'role': 'CONTACT', 'email': 'n_shehadeh@rambam.health.gov.il'}, {'name': 'Naim Shehadeh, Prof', 'role': 'CONTACT'}], 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'David Zangen, Dr', 'role': 'CONTACT', 'email': 'ZANGEND@hadassah.org.il'}, {'name': 'David Zangen, Dr', 'role': 'CONTACT'}], 'facility': 'Hadassah medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Avner Cohen, Prof', 'role': 'CONTACT', 'email': 'hermanc@tauex.tau.ac.il', 'phone': '972-523-870-827'}, {'name': 'Avner Cohen, Prof', 'role': 'CONTACT'}], 'facility': 'Child Health Centers all over Israel (clalit Health Services)', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Alona Hamou, MSc', 'role': 'CONTACT', 'email': 'alonah@clalit.org.il', 'phone': '972-545-950-277'}, {'name': 'Moshe Phillip, Prof', 'role': 'CONTACT'}, {'name': 'Tal Oron, Dr.', 'role': 'CONTACT'}], 'facility': 'Schneider Children Medical Center of Israel', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Ramat Gan', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Orit Hamiel, Prof', 'role': 'CONTACT', 'email': 'Orit.Hamiel@sheba.health.gov.il'}, {'name': 'Orit Hamiel, Prof', 'role': 'CONTACT'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Tel Aviv', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yael Lebenthal, Prof', 'role': 'CONTACT', 'email': 'yaelleb@tlvmc.gov.il'}, {'name': 'Yael Lebenthal, Prof', 'role': 'CONTACT'}], 'facility': "Dana-Duek children's hospital", 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Moshe Phillip, Prof', 'role': 'CONTACT', 'email': 'moshe.phillip@phillipmd.com', 'phone': '972-544-795-995'}, {'name': 'Alona Hamou, MSc', 'role': 'CONTACT', 'email': 'alonah@clalit.org.il', 'phone': '972-545-950-277'}], 'overallOfficials': [{'name': 'Moshe Phillip, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': "Schneider Children's Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}