Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-04 @ 9:23 PM
Study NCT ID:
NCT04169867
Status:
UNKNOWN
Last Update Posted:
2019-11-20
First Post:
2019-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polish Microbiome Map
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'C000594389', 'term': 'atezolizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2019-11-18', 'studyFirstSubmitQcDate': '2019-11-19', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbial diversity in stool samples', 'timeFrame': 'Inclusion', 'description': 'Microbial DNA - stool samples sequenced by next-generation sequencing platform.'}, {'measure': 'Eating habits and health survey', 'timeFrame': 'Inclusion', 'description': "It includes questions about healthy volunteers' and patients' eating habits that may relate to their health."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiome', 'Melanoma', 'Healthy Volunteers', 'Immunotherapy', 'Stool samples', 'Cancer', 'Metagenome', 'Neoplasms', 'Intestinal microbiota', 'Nivolumab', 'Ipilimumab', 'Atezolizumab'], 'conditions': ['Melanoma', 'Healthy Volunteers', 'Microbiome', 'Metagenome', 'Immunotherapy']}, 'descriptionModule': {'briefSummary': "Knowledge about the correlations between the composition of the gut microbiome and a wide range of diseases has substantially increased in recent years. Nonetheless, there is no reference set of information about the microbiome in Poland. The development of such a reference will allow polish scientists conducting research in the field of interaction between gut flora components and such characteristics as lifestyle, certain diseases or patient's responses for treatment. Following the example of such countries as the United States, investigators propose to build a unique set of scientific processed information describing the variability of the polish population microbiome (Polish Microbiome Map). The investigators will provide a reliable dataset that will characterize the gut microbiomes and their diversity in the polish population. Additionally, thanks to the creation of the standard protocol for microbiome data collection the research conducted by the MMP users will be comparable with the information deposited in MMP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers or oncology patients with primary care clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Healthy Volunteers group:\n\n* Men or women ≥18 years of age\n* Patients with informed consent to participate in the study.\n\nInclusion Criteria for Melanoma group:\n\n* Men or women ≥18 years of age\n* Patients with melanoma\n* Patients with informed consent to participate in the study.\n* Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).\n* The applied immunotherapy should be the first or second line of treatment.\n\nExclusion Criteria:\n\n* Patients or Healthy Volunteers who are unable to understand, read and / or sign the informed consent\n* Patients or Healthy Volunteers who can not collect stools\n* Patients with a fecal transplant\n* The applied immunotherapy is not the first or second line of treatment.'}, 'identificationModule': {'nctId': 'NCT04169867', 'briefTitle': 'Polish Microbiome Map', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ardigen'}, 'officialTitle': 'Polish Microbiome Map', 'orgStudyIdInfo': {'id': 'MMP'}, 'secondaryIdInfos': [{'id': 'POIR.04.01.02-00-0025/17', 'type': 'OTHER_GRANT', 'domain': 'The National Centre for Research and Development'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Volunteers', 'description': 'This cohort will consist of 1000 healthy volunteers from Poland.'}, {'label': 'Melanoma', 'description': 'This cohort will consist of 160 patients with melanoma.', 'interventionNames': ['Biological: Collection of stool samples']}], 'interventions': [{'name': 'Collection of stool samples', 'type': 'BIOLOGICAL', 'otherNames': ['Nivolumab', 'Ipilimumab', 'Atezolizumab'], 'description': 'Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).', 'armGroupLabels': ['Melanoma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poznan', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'role': 'CONTACT', 'email': 'gmp.mmp@ibch.poznan.pl'}], 'facility': 'The Institute of Bioorganic Chemistry, Polish Academy of Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Anna Philips, PhD', 'role': 'CONTACT', 'email': 'gmp.mmp@ibch.poznan.pl', 'phone': '+48 61 852 89 19'}, {'name': 'Emilia Strycharz-Angrecka', 'role': 'CONTACT', 'email': 'emilia.strycharz-angrecka@ardigen.com', 'phone': '+48 12 340 94 94'}], 'overallOfficials': [{'name': 'Anna Philips, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Institute of Bioorganic Chemistry, Polish Academy of Sciences'}, {'name': 'Jan Majta', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ardigen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ardigen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Institute of Bioorganic Chemistry, Polish Academy of Sciences', 'class': 'UNKNOWN'}, {'name': 'National Center for Research and Development, Poland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}