Malignant Pediatric Pelvic Tumors: A Retrospective Study

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02557256
Collaborator
(none)
90
1
83
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Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Malignant Pediatric Pelvi-abdominal Tumors: A Retrospective Study
    Study Start Date :
    Jan 1, 2016
    Anticipated Primary Completion Date :
    Nov 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Assiut Egypt 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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:
    Sep 23, 2015
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by Ahmed Mohammed Morsy, MD, Lecturer, Pediatric Oncology Department, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 12, 2022