Malignant Pediatric Pelvic Tumors: A Retrospective Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02557256|
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : January 11, 2019
|Condition or disease|
|Abdominal Neoplasms Pelvic Neoplasms|
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 Type :||Observational|
|Estimated Enrollment :||90 participants|
|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|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557256
|Assiut, Egypt, 71515|
|Contact: Ahmed M. Morsy, MD +2 01003314522 firstname.lastname@example.org|
|Principal Investigator: Ahmed M. Morsy, MD|
|Principal Investigator: Badawy M. Ahmed, MD|
|Principal Investigator: Khalid M. Rezk, MD|
|Principal Investigator: Ameer M. Abuelgheet, MD|