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| Name | Class |
|---|---|
| Shefa Al-orman Children Cancer Hospital | UNKNOWN |
| Assiut University | OTHER |
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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:
Demographic data as: Age, sex, residence and date of diagnosis.
Clinical history and Physical examination including
II. Laboratory studies done for diagnosis of renal tumors at presentation:
- Complete blood count: presence/absence of polycythemia, anemia, thrombocytopenia
III. Imaging Studies:
Abdominal ultrasound
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
Chest computed tomography scan.
Echocardiography: To
IV. Pathology:
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:
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)
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| Measure | Description | Time Frame |
|---|---|---|
| Overall-survival (OS) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Children and young adolescene younger than 18 years of age admitted and treated at Shefa Al-orman Children Cancer Hospital during the study period
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud Elzembely, MD | Contact | +201146703107 | elzimbily@aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mahmoud Elzembely, MD | South Egypt Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shefa Al-orman Children Cancer Hospital | Recruiting | Luxor | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33258687 | Background | 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. | |
| 29089605 |
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| ID | Term |
|---|---|
| D009396 | Wilms Tumor |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
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| Result |
| 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. |
| D014571 |
| Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |