Image

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

Recruiting
18 years and younger
All
Phase N/A

Powered by AI

Overview

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).

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)

Eligibility

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.

Study details
    Wilms Tumor

NCT06288802

South Egypt Cancer Institute

7 March 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.