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Malignant Genito-urinary Tumors in Children: South Egypt Cancer Institute Experience

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ClinicalTrials.gov Identifier: NCT02557230
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohammed Morsy, MD, Assiut University

Brief Summary:
The aim of this study is to identify demographic & disease characteristics in pediatric oncology patients diagnosed with one of genitourinary tumors & treatment outcomes in these patients.

Condition or disease
Genitourinary Neoplasms Neoplasms, Genitourinary

Detailed Description:

Background:

Tumors of the kidney, bladder, prostate, testis, and adrenal represent a large part of the adult urologic practice, but are relatively infrequent in children.

Genitourinary tumors contribute to pediatric solid tumors. Wilms tumor, rhabdomyosarcoma, and germ cell tumors are the most common malignant genitourinary tumors in children.

The natural history and management of these tumors in the pediatric age is different from that of the adults. As result of the successful work of several clinical trial groups in recent decades, there has been a significant improvement in their cure rates.

Patients & Methods:

From January 2001 till December 2015, retrieval & analysis of the medical records of pediatric patients with genitourinary tumors will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. These data will be categorized according to demographic characteristics, clinico-pathologic features, treatment modalities received, and outcomes of treatments in these patients.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Malignant Genito-urinary Tumors in Children: South Egypt Cancer Institute Experience
Study Start Date : January 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021



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
Pediatric cancer patients, those diagnosed with any of genitourinary neoplasms, in the period from 2001 January till 2015 December, and received treatment at the pediatric oncology department, their medical records will be retrospectively reviewed for data collection.
Criteria

Inclusion Criteria:

  • Patients whose age less than or equal to 18 years.
  • Patients diagnosed with any of neoplasms affecting the genitourinary system.

Exclusion Criteria:

  • Patients whose age more than 18 years.

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): NCT02557230


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: Khalid M. Rezk, MD         
Principal Investigator: Badawy M. Ahmed, MD         
Principal Investigator: Ameer M. Abuelgheet, MD         
Sponsors and Collaborators
Assiut University
Publications:
Lambert S. Adult Survivors of Pediatric Genitourinary Tumors. In: Wood HM, Wood D, editors. Transition and Lifelong Care in Congenital Urology: Springer International Publishing; 2015. p. 209-16.

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Responsible Party: Ahmed Mohammed Morsy, MD, Lecturer, Pediatric Oncology Department, Assiut University
ClinicalTrials.gov Identifier: NCT02557230    
Other Study ID Numbers: Ped GU Tumors
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Keywords provided by Ahmed Mohammed Morsy, MD, Assiut University:
Childhood Cancer
Genitourinary tumors
urogenital tumors
Pediatric Oncology
Additional relevant MeSH terms:
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Urogenital Neoplasms
Neoplasms
Neoplasms by Site