Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT06288802
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Wilms Tumors Among Patients of Shefa Al-Orman Children Cancer Hospital
Sponsor:
South Egypt Cancer Institute
Organization:
Study Overview
Official Title:
Study of Wilms Tumors Among Patients of Shefa Al-Orman Children Cancer Hospital
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: