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

February 24, 2024 updated by: Mahmoud Motaz Elzembely, South Egypt Cancer Institute
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).

Study Overview

Status

Recruiting

Conditions

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)

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Luxor, Egypt
        • Recruiting
        • Shefa Al-orman Children Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children and young adolescene younger than 18 years of age admitted and treated at Shefa Al-orman Children Cancer Hospital during the study period

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall-survival (OS)
Time Frame: from date of diagnosis to last date of follow up or date of death for any cause
will be calculated from date of diagnosis to last date of follow up or date of death for any cause
from date of diagnosis to last date of follow up or date of death for any cause

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival (EFS)
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Egypt Cancer Institute

Collaborators

Assiut University
Shefa Al-orman Children Cancer Hospital

Investigators

  • Principal Investigator: Mahmoud Elzembely, MD, South Egypt Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 24, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Estimated)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 24, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2023-200647

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wilms Tumor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe