Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-27 @ 6:30 AM
Study NCT ID:
NCT03936634
Status:
UNKNOWN
Last Update Posted:
2020-12-21
First Post:
2019-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Innovative Approach Towards Understanding and Arresting Type 1 Diabetes (INNODIA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, plasma, whole blood, urine, stool, dried blood spot'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-17', 'studyFirstSubmitDate': '2019-03-21', 'studyFirstSubmitQcDate': '2019-04-30', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arm A - Newly Diagnosed people with Type 1 diabetes', 'timeFrame': '24 months', 'description': 'Rate of decline in Beta cell function as assessed by mixed meal tolerance test and home dried blood spot C-peptide measures over the first 24 months from diagnosis of Type 1 diabetes.'}, {'measure': 'Arm B - Auto-antibody positive first degree family members', 'timeFrame': '48 months', 'description': 'Development of diabetes as defined by the American Diabetes Association in auto-antibody positive family members followed longitudinally.'}], 'secondaryOutcomes': [{'measure': 'Arm A - Newly diagnosed patients with Type 1 diabetes', 'timeFrame': '24 months', 'description': 'Changes in HbA1c, insulin dose, autoantibody levels over the first 24 months from diagnosis.'}, {'measure': 'Arm A - Newly diagnosed patients with Type 1 diabetes - Systematic evaluation of biological samples', 'timeFrame': '24 months', 'description': "Systematic evaluation of biological samples using multiple 'omics' approach to identify biomarkers which predict rate of deterioration in C-peptide measures"}, {'measure': 'Arm A - Newly diagnosed patients with Type 1 diabetes - Framework', 'timeFrame': '24 months', 'description': 'To develop a robust observational framework for future interventional studies.'}, {'measure': 'Arm B - Auto-antibody positive first degree family members - glucose tolerance', 'timeFrame': '48 months', 'description': 'Changes in glucose tolerance as determined by repeated oral glucose tolerance tests over the follow up period of 48 months'}, {'measure': 'Arm B - Auto-antibody positive first degree family members - Systematic evaluation of biological samples', 'timeFrame': '48 months', 'description': "Systematic evaluation of biological samples, using multiple 'omics' approach, auto antibodies to identify biomarkers which predict rate of progression to diabetes."}, {'measure': 'Arm B - Auto-antibody positive first degree family members - Framework', 'timeFrame': '48 months', 'description': 'Developing a robust framework for future interventional studies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Observation study', 'First degree relatives', 'Beta cell', 'C-Peptide', 'Immune cells', 'Disease progression'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '36761922', 'type': 'DERIVED', 'citation': 'Andellini M, Haleem S, Angelini M, Ritrovato M, Schiaffini R, Iadanza E, Pecchia L. Artificial intelligence for non-invasive glycaemic-events detection via ECG in a paediatric population: study protocol. Health Technol (Berl). 2023;13(1):145-154. doi: 10.1007/s12553-022-00719-x. Epub 2023 Jan 23.'}, {'pmid': '34876434', 'type': 'DERIVED', 'citation': 'Wilhelm-Benartzi CS, Miller SE, Bruggraber S, Picton D, Wilson M, Gatley K, Chhabra A, Marcovecchio ML, Hendriks AEJ, Morobe H, Chmura PJ, Bond S, Aschemeier-Fuchs B, Knip M, Tree T, Overbergh L, Pall J, Arnaud O, Haller MJ, Nitsche A, Schulte AM, Mathieu C, Mander A, Dunger D. Study protocol: Minimum effective low dose: anti-human thymocyte globulin (MELD-ATG): phase II, dose ranging, efficacy study of antithymocyte globulin (ATG) within 6 weeks of diagnosis of type 1 diabetes. BMJ Open. 2021 Dec 7;11(12):e053669. doi: 10.1136/bmjopen-2021-053669.'}]}, 'descriptionModule': {'briefSummary': 'INNODIA is a global consortium linking 26 academic institutions, 4 industrial partners, a small to medium enterprise (SME), and 2 patient organisations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu).\n\nThe project, approved in November 2015 and launched in January 2016, runs under the framework of the Innovative Medicines Initiative - Joint Undertaking (https://www.imi.europa.eu/projects-results/project-factsheets/innodia) with a dedicated governance structure ensuring close interaction, communication and adherence to the objectives and deliverables of the consortium.\n\nThe overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe, with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families.\n\nOne of the objectives of INNODIA is to develop a new European clinical research network with standardized protocol based on repeated measures of C-peptide (including home measurements) and comprehensive collection of appropriate biological samples for \'omics\', immune, viral and microbiome studies in new onset T1D patients and high-risk auto-antibody positive subjects. A protocol for the harmonization of sample collections in newly diagnosed type 1 diabetic patients and first degree relatives of patients with type 1 diabetes was developed following extensive preliminary work involving partners from across all specialities. Core laboratories with experience in their respective field were set up for analysis of auto-antibodies, fresh immune cells, handling of frozen immune cells, C-peptide measures. A series of standard operating procedures for sample collections and analysis were agreed. Sample tracking between clinical centres and central laboratories was included into a purposely designed electronic case report form (eCRF) into which all clinical and laboratory data collected are captured.', 'detailedDescription': "This is a longitudinal observational study of the relationship between measures of β-cell function, genotype, immunological phenotype and potential environmental factors over time, in individuals with new onset T1D or first degree relatives at higher risk for T1D due to the presence of auto-antibodies.\n\nIt is a multicentre international study involving clinical centres across Europe which is unique in the following ways:\n\n1. The first such collaboration in Europe\n2. Novel evaluation of C-peptide/β-cell function using both home dried blood spots and regular hospital mixed meal tolerance tests or oral glucose tolerance tests\n3. Identical study procedures across all clinical centres\n4. Centralised analysis/storage of clinically relevant samples\n5. The creation of a living 'Biobank' whereby participants can be recalled for study on the basis of specific genotype/phenotypes\n6. Linkage to innovative study of novel biomarkers to inform future interventional strategies\n7. A potential pipeline for future recruitment and consent to novel innovative interventional strategies\n\nThe study is divided into 2 arms:\n\nIn arm A, the investigators plan to recruit 1500 newly diagnosed T1D patients within 6 weeks from diagnosis. The last study visit will be planned 2 years from diagnosis or until the end of the study. Therefore, the duration of the study will be approximately 2 years consisting of 5 visits. At baseline, C-peptide and immunophenotyping are evaluated. Follow up consists of regular mixed meal tolerance test (MMTT) and providing blood, urine and stool samples for 'omics', immune, viral and microbiome studies. Home dried blood spots (DBS) pre and post a standardized meal will be collected monthly for the duration of the study.\n\nThese recruited participants will be included for further observational study, confirmation of potential biomarkers and will ultimately provide a pipeline for future recruitment to interventional studies.\n\nIn arm B, the investigators plan to screen approximately 4500 unaffected first degree family members across all centres during the first 3 years. The family members will be screened for 4 auto-antibodies (GAD65, IA-2A, IAA, ZnT8A).\n\nUnaffected family members who are auto-antibody positive will be followed up for approximately 4 years consisting of visits every 6 months for the first 2 years and then every 12 months until the end of the study. Follow up will consist of regular oral glucose tolerance test (OGTT) and providing blood, urine and stool samples for 'omics', immune, viral and microbiome studies. Home dried blood spots (DBS) will be collected monthly for the duration of the study.\n\nUnaffected participants who are auto-antibody negative will be sent annual questionnaires until the end of the study.\n\nAll study participants will be consented to a living 'Biobank' where we will be able to request participants to be recalled by genotype/phenotype for further studies involving blood, urine and stool samples."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '44 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed patients with Type 1 diabetes.\n\nUnaffected first degree family members of patients with type 1 diabetes.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Newly diagnosed:\n\nInclusion Criteria:\n\n* Have given written informed consent to participate.\n* Be aged between 1 year and \\<45 years.\n* Less than 6 weeks from diagnosis of type 1 diabetes and requiring insulin treatment.\n\nExclusion Criteria:\n\n* Non-type 1 diabetes (type 2, monogenic diabetes and secondary diabetes)\n* Concurrent use of long term immunosuppressive agents including oral steroids or medication likely to confound the interpretation of study results.\n* Expected non-compliance with the protocol.\n* Any medical history or clinical relevant abnormality that is deemed by the principal investigator and/or co-investigator to make the patient ineligible for inclusion because problems in interpreting data or safety concern.\n* Participating in interventional or other drug research studies which could affect the primary objectives of the study.\n\nUnaffected Family Members:\n\nInclusion Criteria:\n\n* Have given written informed consent to participate.\n* Be aged between 1 year and \\<45 years.\n* Have a first degree relative with type 1 diabetes (parent, child, full or half siblings) diagnosed \\<45 years of age\n\nExclusion Criteria:\n\n* The affected first degree relative has type 2 diabetes, monogenic diabetes or diabetes secondary to another medical condition.\n* Concurrent use of long term immunosuppressive agents including oral steroids or medication likely to confound the interpretation of study results.\n* Expected non-compliance with the protocol.\n* Any medical history or clinical relevant abnormality that is deemed by the principal investigator and/or co-investigator to make the patient ineligible for inclusion because problems in interpreting data or safety concern.\n* Participating in interventional or other drug research studies which could affect the primary objectives of the study.'}, 'identificationModule': {'nctId': 'NCT03936634', 'acronym': 'INNODIA', 'briefTitle': 'An Innovative Approach Towards Understanding and Arresting Type 1 Diabetes (INNODIA)', 'organization': {'class': 'OTHER', 'fullName': 'University of Cambridge'}, 'officialTitle': 'An Innovative Approach Towards Understanding and Arresting Type 1 Diabetes (INNODIA)', 'orgStudyIdInfo': {'id': 'INNODIA 01'}, 'secondaryIdInfos': [{'id': '210497', 'type': 'OTHER', 'domain': 'IRAS Project ID'}, {'id': '115797', 'type': 'OTHER_GRANT', 'domain': 'Innovative Medicines Initiative'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Newly Diagnosed (ND)', 'description': 'Recruited within 6 weeks of type 1 diabetes diagnosis. Age between 1 and \\<45 years'}, {'label': 'Unaffected Family members (UFM)', 'description': 'Participants who are not diabetic but have a first degree relative with type 1 diabetes diagnosed \\< 45 years of age.\n\nAge between 1 and \\<45 years'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Thomas Pieber', 'role': 'CONTACT', 'email': 'thomas.pieber@medunigraz.at'}, {'name': 'Gerlies Treiber', 'role': 'CONTACT', 'email': 'gerlies.treiber@medunigraz.at'}, {'name': 'Thomas Pieber', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Miriam Cnop', 'role': 'CONTACT', 'email': 'mcnop@ulb.ac.uk'}, {'name': 'Miriam Cnop', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitee Libre de Bruxelles', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Chantal Mathieu', 'role': 'CONTACT', 'email': 'chantal.mathieu@kuleuven.be'}, {'name': 'Kristina Casteels', 'role': 'CONTACT', 'email': 'kristina.casteels@kuleuven.be'}, {'name': 'Chantal Mathieu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pieter Gillard', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kristina Casteels', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Katholieke Universiteit Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jesper Johannesen', 'role': 'CONTACT', 'email': 'jesper.johannesen@regionh.dk'}, {'name': 'Jesper Johannesen', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jannet Svensson', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Recruitment queries', 'role': 'CONTACT', 'email': 'pedia-innodia@helsinki.fi'}, {'name': 'Mikael Knip', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Helsinki', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Oulu', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Riitta Veijola', 'role': 'CONTACT', 'email': 'riitta.veijola@oulu.fi'}, {'name': 'Riitta Veijola', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Oulu', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Turku', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Jorma Toppari', 'role': 'CONTACT', 'email': 'jorma.toppari@utu.fi'}, {'name': 'Jorma Toppari', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Recruitment queries', 'role': 'CONTACT', 'email': 'trakrstudy@gmail.com'}, {'name': 'Roberto Mallone', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut National de la Sante et de la Recherche Medicale (INSERM)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Recruitment queries', 'role': 'CONTACT', 'email': 'innodia@hka.de'}, {'name': 'Thomas Danne', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Auf der Bult, Hannover Medical School", 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Ulm', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Reinhard Holl', 'role': 'CONTACT', 'email': 'reinhard.holl@uni-ulm.de'}, {'name': 'Stefanie Lanzinger', 'role': 'CONTACT', 'email': 'stefanie.lanzinger@uni-ulm.de'}, {'name': 'Reinhard Holl', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pauline Grogan', 'role': 'CONTACT', 'email': 'grogan.pauline@hsr.it'}, {'name': 'Emauele Bosi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Raffaele Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valentina Pampanini', 'role': 'CONTACT', 'email': 'valentina.pampanini@opbg.net'}, {'name': 'Stefano Cianfarani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Pediatrico Bambino Gesu', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Siena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Dotta', 'role': 'CONTACT', 'email': 'francesco.dotta@unisi.it'}, {'name': 'Francesco Dotta', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Studi di Siena', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'city': 'Luxembourg', 'status': 'RECRUITING', 'country': 'Luxembourg', 'contacts': [{'name': 'Carine De Beaufort', 'role': 'CONTACT', 'email': 'debeaufort.carine@chl.lu'}, {'name': 'Carine De Beaufort', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Luxembourg', 'geoPoint': {'lat': 49.60982, 'lon': 6.13268}}, {'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Knut Dahl-Jørgensen', 'role': 'CONTACT', 'email': 'knut.dahl-jorgensen@medisin.uio.no'}, {'name': 'Knut Dahl-Jørgensen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oslo Universitetssytehus HF', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Katowice', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Przemyslawa Jarosz-Chobot', 'role': 'CONTACT', 'email': 'przemka1@o2.pl'}, {'name': 'Przemyslawa Jarosz-Chobot', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Silesia Katowice', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Darja Smigoc', 'role': 'CONTACT', 'email': 'darja.smigoc@kclj.si'}, {'name': 'Tadej Battelino', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'city': 'Malmo', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Linda Ahlkinst', 'role': 'CONTACT', 'email': 'linda.ahlkvist@med.lu.se'}, {'name': 'Markus Lundgren', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Lund', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Recruitment queries', 'role': 'CONTACT', 'email': 'INNODIA-recruit@paed.cam.ac.uk'}, {'name': 'Ajay Thankamony', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Cambridge', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'centralContacts': [{'name': 'David B Dunger', 'role': 'CONTACT', 'email': 'dbd25@cam.ac.uk', 'phone': '+44 1223 336886'}, {'name': 'Sylvaine Bruggraber', 'role': 'CONTACT', 'email': 'sb2194@medschl.cam.ac.uk', 'phone': '+44 1223 769063'}], 'overallOfficials': [{'name': 'David B Dunger', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}, {'name': 'Mikael Knip', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Helsinki'}, {'name': 'Chantal Mathieu', 'role': 'STUDY_CHAIR', 'affiliation': 'Katholieke Universteit Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cambridge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovative Medicines Initiative', 'class': 'OTHER'}, {'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}, {'name': 'The Leona M. and Harry B. Helmsley Charitable Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Paediatrics', 'investigatorFullName': 'David Dunger', 'investigatorAffiliation': 'University of Cambridge'}}}}