Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT04567212
Status:
UNKNOWN
Last Update Posted:
2020-11-23
First Post:
2020-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gender Differences and SNPs in Asthmatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'we will take the oral swab in order to evaluate the enzyme expression'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-20', 'studyFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2020-09-22', 'lastUpdatePostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression of SNPs', 'timeFrame': '1 month', 'description': 'statistically significant difference (P\\<0.05) in SNPs expression between male and female'}], 'secondaryOutcomes': [{'measure': 'Concentration of MicroRNA', 'timeFrame': '1 month', 'description': 'statistically significant difference (P\\<0.05) in microRNA between male and female'}, {'measure': 'SNPs and age', 'timeFrame': '1 month', 'description': 'statistically significant difference (P\\<0.05) in SNPs expression between age \\> 12 years and \\< 12 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'allergy', 'Gender', 'polymorphism'], 'conditions': ['Allergic Asthma', 'Asthma']}, 'descriptionModule': {'briefSummary': 'The GINA 2020 guidelines suggest that asthma affects approximately 300 million persons worldwide. Even if there is a specific drug treatment for each stage of disease (From mild to severe) in some patients it is not efficacy and it culd be reated to the gender difference Polymorphisms seems to be involved in asthma (allergic or not) even if no data have been published concerning the role of gender in this clinical manifestation. The aim of this study is to assess whether genetic variations involved in the genes encoding the two key leukotriene enzymes, ALOX5 and LTC4S, and CysLTR1 are implicated in the sex difference of allergic asthma in a well-characterized patient cohort.', 'detailedDescription': 'The GINA 2020 guidelines suggest that asthma affects approximately 300 million persons worldwide. Even if there is a specific drug treatment for each stage of disease (From mild to severe) in some patients it is not efficacy and it culd be reated to the gender difference Polymorphisms seems to be involved in asthma (allergic or not) even if no data have been published concerning the role of gender in this clinical manifestation. The role of polymorphisms in susceptibility to allergic asthma has been partially investigated but no study has analysed gender subgroups separately, neglecting a their potential predictive role in symptomatological and functional variations in the allergic asthma in both sexes. The aim of this study is to assess whether genetic variations involved in the genes encoding the two key leukotriene enzymes, ALOX5 and LTC4S, and CysLTR1 are implicated in the sex difference of allergic asthma in a well-characterized patient cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will perform an observational study in patients with asthma enrolled fro general practitioners and specialist in respiratory disease. After the recruitment a sample of blood and oral mucosa will be taken to evaluate the expression of SNPs and of inflammatory status', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* asthma (allergic or not) diagnosed according to Global Initiative for Asthma guidelines (GINA 2020).\n* signed informed consent\n\nExclusion Criteria:\n\n* • infectious diseases\n\n * neurodegenerative diseases\n * autoimmune diseases\n * neoplasms\n * progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)\n * alcohol consumption (\\>3 alcoholic beverages daily)\n * substanceabuse\n * inability to give written informed consent\n * those who will not sign the consent to the processing of personal data'}, 'identificationModule': {'nctId': 'NCT04567212', 'briefTitle': 'Gender Differences and SNPs in Asthmatic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Catanzaro'}, 'officialTitle': 'Gender Differences and SNPs in Asthmatic Patients', 'orgStudyIdInfo': {'id': 'SNPS asthma'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Male-group', 'description': 'in this group we will enroll only male with asthma', 'interventionNames': ['Genetic: genetic evaluation', 'Other: MicroRNA evaluation']}, {'label': 'Female-group', 'description': 'in this group we will enroll only female with asthma', 'interventionNames': ['Genetic: genetic evaluation', 'Other: MicroRNA evaluation']}], 'interventions': [{'name': 'genetic evaluation', 'type': 'GENETIC', 'description': 'A sampe of blood (3 mL) and of oral mucosa will be take and analyzed using nCounter GX Human Inflammation Kit a comprehensive number of 8SNPs in 3 human genes known to be differentially expressed in allergic asthma.', 'armGroupLabels': ['Female-group', 'Male-group']}, {'name': 'MicroRNA evaluation', 'type': 'OTHER', 'description': 'Using the sampe of blood (3 mL) using RT-PCR we will evaluate the expression of microRNA in enrolled patients', 'armGroupLabels': ['Female-group', 'Male-group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'state': 'Italia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Gallelli, MD', 'role': 'CONTACT', 'email': 'gallelli@unicz.it', 'phone': '+390961712537'}], 'facility': 'AO Materdomini', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '88100', 'city': 'Catanzaro', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Guerra, MD', 'role': 'CONTACT', 'email': 'guerra.antonio@simg.it', 'phone': '3398199190'}, {'name': 'Antonio Scuteri, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Giacomo Leuzzi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Giuseppe Giuliano, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'ASP Catanzaro', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catanzaro', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Sanitaria Provinciale Di Catanzaro', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliera Universitaria Mater Domini, Catanzaro', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Luca Gallelli', 'investigatorAffiliation': 'University of Catanzaro'}}}}