Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-02-20 @ 6:45 PM
Study NCT ID:
NCT02940093
Status:
UNKNOWN
Last Update Posted:
2017-11-14
First Post:
2016-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D033581', 'term': 'Stem Cell Transplantation'}], 'ancestors': [{'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urine Feces Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-10', 'studyFirstSubmitDate': '2016-10-13', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune system - intestinal microbiota co-re-emergence after myeloablative conditioning and antibiotics treatment, respectively.', 'timeFrame': 'through study completion, anticipated after 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stem Cell Transplantation']}, 'descriptionModule': {'briefSummary': 'The combined analysis of microbiome, immunological parameters and host genetics in patients has potential for applying personalized approaches of prevention, diagnostics or therapy in the future. However, the acquisition and analysis of these patient characteristics in a scientifically sound, technically reliable, cost-effective, practicable and future-oriented fashion are a far from trivial task. Therefore the objectives of the study are (i) to optimize a sample and data acquisition and analysis pipeline that fulfills these criteria (using samples from healthy volunteers); (ii) validate the pipeline in a cohort of children undergoing stem cell transplantation, yielding information on host immuno-genetics, gut immune function and the human gut microbiome; (iii) deduct the most critical parameters for host-microbiome interplay from this complex dataset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing stem cell transplantation due to hematological malignancies Allogeneic stem cell donors', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient (stem cell recipient) with hematological malignancies, age 3-18\n* Healthy allogeneic stem cell donor (identical or non-identical related donor)\n\nExclusion Criteria:\n\n* Patients \\<3 years of age\n* Patient who are unable to provide urine, stool or blood samples due to their medical condition'}, 'identificationModule': {'nctId': 'NCT02940093', 'acronym': 'ImMiGeNe', 'briefTitle': 'Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Implementation of a Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers for Stratified Clinical Management', 'orgStudyIdInfo': {'id': 'ImMiGeNe-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stem cell transplant recipient', 'interventionNames': ['Other: Stem cell transplantation']}, {'label': 'Stem cell donor'}], 'interventions': [{'name': 'Stem cell transplantation', 'type': 'OTHER', 'description': 'Intervention is not conducted as part of the study but patients at Tübingen University Hospital undergoing this intervention as part of their standard care are being monitored in this observational study.', 'armGroupLabels': ['Stem cell transplant recipient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Lang, MD', 'role': 'CONTACT', 'email': 'Peter.Lang@med.uni-tuebingen.de', 'phone': '07071', 'phoneExt': '83781'}], 'facility': "University Children's Hospital Tübingen", 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Alexander NR Weber, PhD', 'role': 'CONTACT', 'email': 'alexander.weber@uni-tuebingen.de', 'phone': '+49 7071 29', 'phoneExt': '87623'}, {'name': 'Silke Peter, MD', 'role': 'CONTACT', 'email': 'silke.peter@med.uni-tuebingen.de', 'phone': '+49 7071 29', 'phoneExt': '81527'}], 'overallOfficials': [{'name': 'Alexander NR Weber, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tuebingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}