Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT02557256
Status:
UNKNOWN
Last Update Posted:
2023-07-24
First Post:
2015-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Malignant Pediatric Pelvic Tumors: A Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D010386', 'term': 'Pelvic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2015-09-21', 'studyFirstSubmitQcDate': '2015-09-21', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years', 'description': 'Time from the date of initiation of treatment until death from any cause.'}, {'measure': 'Event Free Survival (EFS)', 'timeFrame': 'Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years', 'description': 'Time from the date of initiation of treatment until disease progression, or death for any reason.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Childhood Cancer', 'Abdominal Tumors', 'Pelvic Tumors', 'Pediatric Oncology'], 'conditions': ['Abdominal Neoplasms', 'Pelvic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '11344486', 'type': 'BACKGROUND', 'citation': 'Groff DB. Pelvic neoplasms in children. J Surg Oncol. 2001 May;77(1):65-71. doi: 10.1002/jso.1068.'}, {'type': 'BACKGROUND', 'citation': 'Skandalakis, J. E. and S. W. Gray (1994). Embryology for surgeons: the embryological basis for the treatment of congenital anomalies, Williams & Wilkins.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to retrospectively review data about malignancies that arise primarily in the pelvis and/or in the pelvic organs, in pediatric cancer patients \\& categorize the spectrum of these malignancies according to experience at South Egypt Cancer Institute which is the largest referral site in Upper Egypt.', 'detailedDescription': 'Background:\n\nThe newborn and infant pelvis is not fully developed and the bladder, uterus, and ovaries are to a large degree intra-abdominal. The pelvis of the infant and child has different anatomic relationships than the adolescent or adult pelvis. Neoplasms of the pediatric pelvis constitute a unique group requiring highly specialized management in a setting staffed by pediatric surgical and radiation oncologists. The most common neoplasms are rhabdomyosarcomas of the bladder, prostate, and vagina; sacrococcygeal teratoma; and the germ cell tumors, including teratomas, endodermal sinus tumors, and the choriocarcinomas. Rapidly improving chemotherapy for all of these lesions has resulted in a changed role for the surgeon.\n\nPatients \\& Methods:\n\nA hospital-based study, involving Pediatric cancer patients, those have been diagnosed with malignant tumors that primarily arising in the pelvis and/or arising from the pelvic organs, and may have an intra-abdominal extension, in the period from 2001 January till 2015 December, and received treatment at the pediatric oncology department, their medical reports will be retrospectively reviewed for data collection.\n\nSpectrum of these malignancies will be categorized and recorded as specific disease entities, based on morphology \\& the primary site of occurrence, their relative incidence will be calculated, and the treatment outcomes will be verified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A hospital-based study, involving Pediatric cancer patients, those diagnosed with malignant tumors of the pelvis, or arising from the pelvic organs, in the period from 2001 January till 2015 December, and received treatment at the pediatric oncology department, their medical reports will be retrospectively reviewed for data collection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients whose age less than 19 years.\n* Patients diagnosed with a primary malignant tumor in the pelvis and/or arising from the pelvic organs.\n\nExclusion Criteria:\n\n* Patients whose age more than 18 years.\n* Patients diagnosed with a malignant disease primarily arising from the bone marrow.'}, 'identificationModule': {'nctId': 'NCT02557256', 'briefTitle': 'Malignant Pediatric Pelvic Tumors: A Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Malignant Pediatric Pelvi-abdominal Tumors: A Retrospective Study', 'orgStudyIdInfo': {'id': 'Ped Pelvi-abd Malig'}}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed M. Morsy, MD', 'role': 'CONTACT', 'email': 'ahmedmohammed7829@yahoo.com', 'phone': '+2 01003314522'}, {'name': 'Ahmed M. Morsy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Badawy M. Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Khalid M. Rezk, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ameer M. Abuelgheet, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, Pediatric Oncology Department', 'investigatorFullName': 'Ahmed Mohammed Morsy, MD', 'investigatorAffiliation': 'Assiut University'}}}}