Malignant Genito-urinary Tumors in Children: South Egypt Cancer Institute Experience

Genitourinary Neoplasms Clinical Trial

Official title:

Malignant Genito-urinary Tumors in Children: South Egypt Cancer Institute Experience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02557230
• Other study ID #: Ped GU Tumors
• Status: Recruiting
• Start date: January 2016
• Est. completion date: April 2024

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 this study is to identify demographic & disease characteristics in pediatric oncology patients diagnosed with one of genitourinary tumors & treatment outcomes in these patients.

Description:

Background:

Tumors of the kidney, bladder, prostate, testis, and adrenal represent a large part of the adult urologic practice, but are relatively infrequent in children.

Genitourinary tumors contribute to pediatric solid tumors. Wilms tumor, rhabdomyosarcoma, and germ cell tumors are the most common malignant genitourinary tumors in children.

The natural history and management of these tumors in the pediatric age is different from that of the adults. As result of the successful work of several clinical trial groups in recent decades, there has been a significant improvement in their cure rates.

Patients & Methods:

From January 2001 till December 2015, retrieval & analysis of the medical records of pediatric patients with genitourinary tumors will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. These data will be categorized according to demographic characteristics, clinico-pathologic features, treatment modalities received, and outcomes of treatments in these patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Patients whose age less than or equal to 18 years.

• Patients diagnosed with any of neoplasms affecting the genitourinary system.

Exclusion Criteria:

• Patients whose age more than 18 years.

Related Conditions & MeSH terms

• Genitourinary Neoplasms
• Neoplasms
• Neoplasms, Genitourinary
• Urogenital 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)

Denes FT, Duarte RJ, Cristofani LM, Lopes RI. Pediatric genitourinary oncology. Front Pediatr. 2013 Dec 16;1:48. doi: 10.3389/fped.2013.00048. — View Citation

Lambert S. Adult Survivors of Pediatric Genitourinary Tumors. In: Wood HM, Wood D, editors. Transition and Lifelong Care in Congenital Urology: Springer International Publishing; 2015. p. 209-16.

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