Malignant Pediatric Pelvic Tumors: A Retrospective Study

Abdominal Neoplasms Clinical Trial

Official title:

Malignant Pediatric Pelvi-abdominal Tumors: A Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02557256
• Other study ID #: Ped Pelvi-abd Malig
• Status: Recruiting
• Start date: January 2016
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Neoplasms
• Neoplasms
• Pelvic Neoplasms

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Groff DB. Pelvic neoplasms in children. J Surg Oncol. 2001 May;77(1):65-71. doi: 10.1002/jso.1068. — View Citation

Skandalakis, J. E. and S. W. Gray (1994). Embryology for surgeons: the embryological basis for the treatment of congenital anomalies, Williams & Wilkins.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	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
Primary	Event Free Survival (EFS)	Time from the date of initiation of treatment until disease progression, or death for any reason.	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