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Malignant Pediatric Pelvic Tumors: A Retrospective Study

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ClinicalTrials.gov Identifier: NCT02557256
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohammed Morsy, MD, Assiut University

Brief Summary:
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.

Condition or disease
Abdominal Neoplasms Pelvic Neoplasms

Detailed Description:

Background:

The 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.

Patients & Methods:

A 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.

Spectrum 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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Malignant Pediatric Pelvi-abdominal Tumors: A Retrospective Study
Study Start Date : January 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020



Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 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 ]
    Time from the date of initiation of treatment until death from any cause.

  2. Event Free Survival (EFS) [ Time Frame: 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 ]
    Time from the date of initiation of treatment until disease progression, or death for any reason.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Patients whose age less than 19 years.
  • Patients diagnosed with a primary malignant tumor in the pelvis and/or arising from the pelvic organs.

Exclusion Criteria:

  • Patients whose age more than 18 years.
  • Patients diagnosed with a malignant disease primarily arising from the bone marrow.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557256


Locations
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Egypt
Assiut University Recruiting
Assiut, Egypt, 71515
Contact: Ahmed M. Morsy, MD    +2 01003314522    ahmedmohammed7829@yahoo.com   
Principal Investigator: Ahmed M. Morsy, MD         
Principal Investigator: Badawy M. Ahmed, MD         
Principal Investigator: Khalid M. Rezk, MD         
Principal Investigator: Ameer M. Abuelgheet, MD         
Sponsors and Collaborators
Assiut University
Publications:
Skandalakis, J. E. and S. W. Gray (1994). Embryology for surgeons: the embryological basis for the treatment of congenital anomalies, Williams & Wilkins.

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Responsible Party: Ahmed Mohammed Morsy, MD, Lecturer, Pediatric Oncology Department, Assiut University
ClinicalTrials.gov Identifier: NCT02557256    
Other Study ID Numbers: Ped Pelvi-abd Malig
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Keywords provided by Ahmed Mohammed Morsy, MD, Assiut University:
Childhood Cancer
Abdominal Tumors
Pelvic Tumors
Pediatric Oncology
Additional relevant MeSH terms:
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Abdominal Neoplasms
Pelvic Neoplasms
Neoplasms
Neoplasms by Site