Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-05 @ 1:52 AM
Study NCT ID:
NCT06480357
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Giant Myelolipoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2024-06-24', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cure of the disease', 'timeFrame': '3 days', 'description': 'Complete myelolipoma resection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benign, neoplasms, adrenal myelolipoma'], 'conditions': ['Adrenal Myelolipoma']}, 'descriptionModule': {'briefSummary': '48-year-old woman who presented with intermittent left flank pain with incidental findings of adrenal tumor on computed tomography (CT). She underwent laparoscopic tumor resection due to a large tumor of 12 cm in size.', 'detailedDescription': 'A 48-year-old female presented to our hospital with the following medical conditions: She denies smoking and drug addiction. Type 2 diabetes mellitus under treatment with metfomin, surgical history of abdominal hysterectomy and open cholecystectomy.\n\nThe patient started experiencing pain located in the left flank for 2 months, which was intermittent, yielded to the administration of analgesics, she denied hematuria and weight loss.\n\nOn physical examination, the abdomen was distended due to adipose tissue, normal bowel sounds were auscultated, and abdominal masses are not palpable.\n\nShe underwent a computed tomography (CT) scan. CT features in the anatomical site of the left adrenal gland, a well-defined ovoid tumor is observed, with heterogeneous content with areas of hypodense (5 HU), fat and calcification. It measures 90 x 69 x 92 mm. Upon application of contrast medium, the hypodense parts present enhancement up to 44 HU. (Fig. 1, 2). She was decided for surgical resection of the tumor via laparoscopic transabdominal approach. The surgery went well without any intraoperative and postoperative complications. She was discharged after day 3.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '48 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '48 Year old Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with myelolipoma\n\nExclusion Criteria:\n\n* Patient without myelolipoma'}, 'identificationModule': {'nctId': 'NCT06480357', 'briefTitle': 'A Giant Myelolipoma.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Mexicano del Seguro Social'}, 'officialTitle': 'A Giant Myelolipoma, Management by Laparoscopy.', 'orgStudyIdInfo': {'id': '98337029'}}, 'armsInterventionsModule': {'interventions': [{'name': 'laparoscopic adrenalectomy', 'type': 'PROCEDURE', 'description': 'laparoscopic transabdominal approach.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92227', 'city': 'Mérida', 'state': 'Yucatán', 'country': 'Mexico', 'facility': 'Mexican Institute Of Social Health', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'July 2024 for ever', 'ipdSharing': 'YES', 'description': 'manuscript publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Huber Díaz Fuentes', 'investigatorAffiliation': 'Instituto Mexicano del Seguro Social'}}}}