- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02557256
Malignant Pediatric Pelvic Tumors: A Retrospective Study
Malignant Pediatric Pelvi-abdominal Tumors: A Retrospective Study
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Assiut, Egypt, 71515
- Recruiting
- Assiut University
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Contact:
- Ahmed M. Morsy, MD
- Phone Number: +2 01003314522
- Email: ahmedmohammed7829@yahoo.com
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Principal Investigator:
- Ahmed M. Morsy, MD
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Principal Investigator:
- Khalid M. Rezk, MD
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Principal Investigator:
- Ameer M. Abuelgheet, MD
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Principal Investigator:
- Badawy M. Ahmed, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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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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
|
|
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.
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Groff DB. Pelvic neoplasms in children. J Surg Oncol. 2001 May;77(1):65-71. doi: 10.1002/jso.1068.
- Skandalakis, J. E. and S. W. Gray (1994). Embryology for surgeons: the embryological basis for the treatment of congenital anomalies, Williams & Wilkins.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ped Pelvi-abd Malig
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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