Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-03-07 @ 4:04 PM
Study NCT ID:
NCT03256006
Status:
UNKNOWN
Last Update Posted:
2018-08-03
First Post:
2017-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Inflammation During a 100 Miles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'pro and anti inflammatory biomarkers (reactive oxygen species)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-10-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2017-08-10', 'studyFirstSubmitQcDate': '2017-08-16', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation per and post effort of interleukin 1 plasma level', 'timeFrame': 'Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race', 'description': 'Plasma level of per and post effort of interleukin 1 will be measured'}, {'measure': 'Variation per and post effort of interleukin 6 plasma level', 'timeFrame': 'Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race', 'description': 'Plasma level of per and post effort of interleukin 6 will be measured'}, {'measure': 'Variation of per and post effort of protein C reactive', 'timeFrame': 'Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race', 'description': 'Plasma level of per and post effort of protein C reactive will be measured'}, {'measure': 'Variation per and post effort of interleukin Tumor Necrosis Factor alpha', 'timeFrame': 'Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race', 'description': 'Plasma level of per and post effort of tumor necrosis alpha will be measured'}, {'measure': 'Variation per and post effort of interleukin 4 plasma level', 'timeFrame': 'Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race', 'description': 'Plasma level of per and post effort of interleukin 4 will be measured'}, {'measure': 'Variation per and post effort of interleukin 10 plasma level', 'timeFrame': 'Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race', 'description': 'Plasma level of per and post effort of interleukin 10 will be measured'}, {'measure': 'Variation per and post effort of interleukin 13 plasma level', 'timeFrame': 'Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race', 'description': 'Plasma level of per and post effort of interleukin 13 will be measured'}, {'measure': 'Variation per and post effort of interleukin tumor growth factor beta plasma level', 'timeFrame': 'Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race', 'description': 'Plasma level of per and post effort of tumor growth factor beta'}, {'measure': 'Variation per and post effort of lipids plasma level', 'timeFrame': 'Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race', 'description': 'Plasma level of per and post effort of lipids'}, {'measure': 'Variation per and post effort of lipoproteins plasma level', 'timeFrame': 'Change measures : departure, 25, 49, 72, 100, 126, 144, 164 kilometers (arrival) then at day 1, day 2 and day 7 after the completion of the race', 'description': 'Plasma level of per and post effort of lipoproteins'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sport exercise', 'ultra endurance'], 'conditions': ['Inflammatory Response']}, 'descriptionModule': {'briefSummary': 'To study per and post effort variations of inflammatory biological markers during a 100 miles'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults (age\\>18years)\n* completion of an ultra endurance race (50 miles) during the 2 years before\n\nExclusion Criteria:\n\n* female\n* age\\<18years'}, 'identificationModule': {'nctId': 'NCT03256006', 'acronym': 'TRAIL PHYSIO', 'briefTitle': 'Study Inflammation During a 100 Miles', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Necker-Enfants Malades'}, 'officialTitle': 'Per Effort Study of Inflammation During a 100 Miles', 'orgStudyIdInfo': {'id': '2017-A02397-46'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood sample', 'type': 'OTHER', 'description': 'Blood sample to study per and post effort evolution markers of systemic inflammation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Necker-Enfants Malades', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Romain Jouffroy', 'investigatorAffiliation': 'Hôpital Necker-Enfants Malades'}}}}