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RecruitingNCT06288802Updated Mar 1, 2024

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

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

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
50
Ages
Up to 18 Years
Sex
All
01

Study 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).

Read the 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)

02

Conditions studied

  • Wilms Tumor

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Keywords

  • wilms
  • incidence
  • outcome
03

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
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

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

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.
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

06

Study locations

1 of 1 sites recruiting
  • Shefa Al-orman Children Cancer Hospital
    Luxor, Egypt
    Recruiting
07

References and documents

Publications

  • Basch E, Becker C, Rogak LJ, Schrag D, Reeve BB, Spears P, Smith ML, Gounder MM, Mahoney MR, Schwartz GK, Bennett AV, Mendoza TR, Cleeland CS, Sloan JA, Bruner DW, Schwab G, Atkinson TM, Thanarajasingam G, Bertagnolli MM, Dueck AC. Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Clin Trials. 2021 Feb;18(1):104-114. doi: 10.1177/1740774520975120. Epub 2020 Dec 1. PubMed 33258687 ↗
  • van den Heuvel-Eibrink MM, Hol JA, Pritchard-Jones K, van Tinteren H, Furtwangler R, Verschuur AC, Vujanic GM, Leuschner I, Brok J, Rube C, Smets AM, Janssens GO, Godzinski J, Ramirez-Villar GL, de Camargo B, Segers H, Collini P, Gessler M, Bergeron C, Spreafico F, Graf N; International Society of Paediatric Oncology - Renal Tumour Study Group (SIOP-RTSG). Position paper: Rationale for the treatment of Wilms tumour in the UMBRELLA SIOP-RTSG 2016 protocol. Nat Rev Urol. 2017 Dec;14(12):743-752. doi: 10.1038/nrurol.2017.163. Epub 2017 Oct 31. PubMed 29089605 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06288802
Lead sponsor
South Egypt Cancer Institute
Collaborators
Shefa Al-orman Children Cancer Hospital, Assiut University
Responsible party
Mahmoud Motaz Elzembely (Lecturer of Pediatric Hematology Oncology, South Egypt Cancer Institute) — Principal investigator
First posted
Mar 1, 2024
Start date
Jun 15, 2020
Primary completion
Jun 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 1, 2024

Study contacts

Mahmoud Elzembely, MD
Contact
elzimbily@aun.edu.eg
+201146703107
Mahmoud Elzembely, MD
principal investigator · South Egypt Cancer Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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