Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-26 @ 1:48 AM
Study NCT ID:
NCT00863694
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
2009-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Calprotectin in Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-12', 'studyFirstSubmitDate': '2009-03-16', 'studyFirstSubmitQcDate': '2009-03-17', 'lastUpdatePostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'collection of 150 stool specimens', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cystic fibrosis', 'calprotectin', 'elastase'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Elevated fecal calprotectin is a biomarker for intestinal inflammation in cystic fibrosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients attending the cystic fibrosis clinics at the Children's Hospital of Wisconsin and Froedtert Hospital", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients\n\nExclusion Criteria:\n\n* Informed consent/assent not obtained'}, 'identificationModule': {'nctId': 'NCT00863694', 'briefTitle': 'Fecal Calprotectin in Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Fecal Calprotectin in Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'calpro'}}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Steven Werlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatric Gastroenterology, M.D.', 'investigatorFullName': 'Steve Werlin', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}