Clinical Trial: Malignant Pediatric Pelvic Tumors: A Retrospective Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Malignant Pediatric Pelvi-abdominal Tumors: A Retrospective Study

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.

Detailed Summary:

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.

Sponsor: Assiut University

Current Primary Outcome:

• 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.
• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Assiut University

Dates:
Date Received: September 21, 2015
Date Started: January 2016
Date Completion: December 2017
Last Updated: February 24, 2017
Last Verified: February 2017