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Study of Wilms Tumors Among Patients of Shefa Al-Orman Children Cancer Hospital

Study of Wilms Tumors Among Patients of Shefa Al-Orman Children Cancer Hospital

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06288802
Enrollment
50
Registered
2024-03-01
Start date
2020-06-15
Completion date
2024-12-31
Last updated
2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wilms Tumor

Keywords

wilms, incidence, outcome

Brief summary

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).

Detailed description

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: 1. To determine the percentage of Wilms tumors among pediatric cancers. 2. To study the outcome of patients with Wilms tumor treated according to SIOP Umbrella protocol (1). 3. To study the treatment related complications during therapy according to common terminology criteria of adverse events version 5.0 (CTCAE Version 5.0) (2). Data collection: Each patient is subjected to all the following according to the centre policy: I. History and physical examination at presentation: 1. Demographic data as: Age, sex, residence and date of diagnosis. 2. Clinical history and Physical examination including * Initial signs and symptoms of pediatric renal tumors including palpable abdominal mass, abdominal pain, hypertension, hematuria, weight loss, constipation, diarrhea, urinary tract infection, previous trauma….etc. * Associated congenital anomalies including. Aniridia, genitourinary anomalies, hemihypertrophy * Family history of cancer II. Laboratory studies done for diagnosis of renal tumors at presentation: \- Complete blood count: presence/absence of polycythemia, anemia, thrombocytopenia * Serum chemistries: blood urea nitrogen, creatinine, uric acid, Alanin transaminases, aspartate aminotransferase, serum bilirubin. * Assessment of coagulation factors: prothrombin time, partial thromboplastin time III. Imaging Studies: 1. Abdominal ultrasound 2. 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 3. Chest computed tomography scan. 4. Echocardiography: To * Assess myocardial contractility before starting cardiotoxic chemotherapy. * Detect the presence of tumor in the inferior vena cava or right atrium IV. Pathology: 1. Ultrasound or CT guided True cut needle biopsy is indicated in the following conditions: A- Unusual clinical presentations: \- Age \> 5-6 years or less than 6 months B- Unusual findings by imaging: \- Calcification \- Voluminous adenopathies \- Renal parenchyma not visible \- Almost totally extrarenal process C- Contraindications for the use of Needle Biopsy: * Suspicion of rupture or hemorrhage * Needle biopsy is unlikely to be of benefit in pure cystic structures with no solid component. Immediate surgery to establish the diagnosis is recommended in such cases. 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)

Interventions

None listed

Sponsors

Shefa Al-orman Children Cancer Hospital
CollaboratorUNKNOWN
Assiut University
CollaboratorOTHER
South Egypt Cancer Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* 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

* Patients aged older than 18 years old, died early at presentation before starting chemotherapy, patients with non-Wilms renal tumors, relapsed renal tumors.

Design outcomes

Primary

MeasureTime frameDescription
Overall-survival (OS)from date of diagnosis to last date of follow up or date of death for any causewill be calculated from date of diagnosis to last date of follow up or date of death for any cause

Secondary

MeasureTime frameDescription
Event-free survival (EFS)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.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.

Countries

Egypt

Contacts

Primary ContactMahmoud Elzembely, MD
elzimbily@aun.edu.eg+201146703107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026