Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT04149093
Status:
UNKNOWN
Last Update Posted:
2021-03-17
First Post:
2019-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Association Between Calretinin and the Function of Ganglion Cells in Hirschsprung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006627', 'term': 'Hirschsprung Disease'}, {'id': 'D045888', 'term': 'Ganglion Cysts'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008531', 'term': 'Megacolon'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D017520', 'term': 'Mucinoses'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007150', 'term': 'Immunohistochemistry'}], 'ancestors': [{'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2019-10-23', 'studyFirstSubmitQcDate': '2019-11-01', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term outcomes (Quality of life questionnaire)', 'timeFrame': '1 year', 'description': "To determine if calretinin has a role in the function of ganglion cells in long segment Hirschsprung disease and total colonic aganglionosis.\n\nHAQL (Hirschsprung's disease and Anorectal malformations Quality of Life) questionnaire. For each item the response is scored from 0 to 3 and then, linearly transformed to a 0 (minimum value) to 100 (maximum value) scale. Higher score suggests a better quality of life."}], 'secondaryOutcomes': [{'measure': 'Surgical complications', 'timeFrame': '1 year', 'description': '* Number of reoperations\n* Number of rebiopsies\n* Number of readmissions\n* Number of bowel obstructions\n* Number of bowel perforation\n* Number of anastomotic leaks\n* Number of anastomotic strictures\n* Number of fistula\n* Number of anal stenosis\n* Number of Hirschsprung-associated enterocolitis'}, {'measure': 'Functional outcomes', 'timeFrame': '1 year', 'description': '* Presence of constipation (yes/no)\n* Presence of diarrhea (yes/no)\n* Presence of incontinence and soiling (yes/no)\n* Presence of abdominal distension (yes/no)\n* Presence of dependance on enemas/medications (yes/no)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hirschsprung Disease', 'Ganglion', 'Hirschsprung Disease, Long-Segment', 'Hypoganglionosis']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the outcomes of patients with long segment Hirschsprung disease or total colonic aganglionosis who had negative calretinin staining and positive ganglion cells on the proximal resection margins to those who had both positive findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Hirschsprung disease and a transition zone more proximal to the distal sigmoid', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed histopathological diagnosis of Hirschsprung disease from January 1, 1990 to August 31, 2019\n* Long-segment Hirschsprung disease (type A and B)\n* Total colonic aganglionosis (TCA)\n* Surgery at CHUSJ\n* Tissue blocks of proximal resection margin available for pathological analysis\n* Minimum 1 month of postoperative follow-up\n\nExclusion Criteria:\n\n* Short-segment Hirschsprung disease (conventional form, rectosigmoid junction)\n* Total colonic with small bowel aganglionosis (TCSA)\n* Surgery done at another institution\n* Early deaths\n* Lost to follow-up\n* No documented post-operative outcome'}, 'identificationModule': {'nctId': 'NCT04149093', 'briefTitle': 'The Association Between Calretinin and the Function of Ganglion Cells in Hirschsprung Disease', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'The Association Between Calretinin and the Function of Ganglion Cells in Long Segment and Total Hirschsprung Disease', 'orgStudyIdInfo': {'id': '2020-2597'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Calretinin staining', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Immunohistochemistry'], 'description': 'A paraffin-embedded hematoxylinphloxin-safran sections will be performed on tissue specimens of proximal resection margins to evaluate the presence or absence of ganglion cells.\n\nImmunohistochemistry (IHC) will then be done on paraffin-embedded sections for calretinin staining.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Annie Le-Nguyen, MD', 'role': 'CONTACT', 'email': 'annie.le-nguyen@outlook.com', 'phone': '5146929694'}], 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nelson Piche', 'investigatorAffiliation': "St. Justine's Hospital"}}}}