An observational study in Wilms Tumor, sponsored by South Egypt Cancer Institute. Recruiting at 1 site in Egypt. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by South Egypt Cancer Institute · Observational
The goal of this cross sectional observational study is to determine the percentage of Wilms tumors among pediatric cancers at Shefa Al-Orman Children Cancer Hospital from june 2020 to june 2024,to study the outcome of patients with Wilms tumor treated according to SIOP Umbrella protocol during the study period and to study the treatment related complications during therapy according to common terminology criteria of adverse events version 5.0 (CTCAE Version 5.0).
Research Design and Methods:
Study design: cross sectional study Study setting: Shefa Al-Orman Children Cancer hospital Study period: from June 2020 to June 2024
Study Objectives:
Data collection: Each patient is subjected to all the following according to the centre policy:
I. History and physical examination at presentation:
Clinical history and Physical examination including
II. Laboratory studies done for diagnosis of renal tumors at presentation:
III. Imaging Studies:
Abdominal CT scan or MRI with special attention to
* Presence and function of the opposite kidney
*Evidence of bilateral lesions
*Evidence of involvement of renal vein or inferior vena cava with tumor
*Lymph node involvement
*Liver metastasis
Echocardiography: To
IV. Pathology:
Ultrasound or CT guided True cut needle biopsy is indicated in the following conditions:
A- Unusual clinical presentations:
B- Unusual findings by imaging:
C- Contraindications for the use of Needle Biopsy:
V. Reporting of treament related complications include:
Chemotherapy toxicity will be determined according to WHO Common Terminology Criteria for Adverse Events (CTCAE Version 5.0, 2017) (2).
VI. Treatment: Patients are treated according to SIOP Umbrella protocol (1)
Children and young adolescene younger than 18 years of age admitted and treated at Shefa Al-orman Children Cancer Hospital during the study period
Exclusion Criteria:
Overall-survival (OS)
will be calculated from date of diagnosis to last date of follow up or date of death for any cause
Time frame: from date of diagnosis to last date of follow up or date of death for any cause
Event-free survival (EFS)
will be measured from the date of Wilms tumor diagnosis to the first treatment failure or date of last follow-up. Treatment failure included abandonment of treatment, death, and progressive or relapsed disease.
Time frame: the date of Wilms tumor diagnosis to the first treatment failure or date of last follow-up. Treatment failure included abandonment of treatment, death, and progressive or relapsed disease.
Plan to share: No
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South Egypt Cancer Institute