Wilms TumorNCT06288802
Study of Wilms Tumors Among Patients of Shefa Al-Orman Children Cancer Hospital
An observational study of Wilms Tumor, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Wilms Tumor
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2020to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- Children and young adolescene younger than 18 years of age admitted and treated at Shefa Al-orman Children Cancer Hospital during the study period
Who cannot join
- Patients aged older than 18 years old, died early at presentation before starting chemotherapy, patients with non-Wilms renal tumors, relapsed renal tumors.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Shefa Al-orman Children Cancer Hospital
Luxor
Mahmoud Elzembely, MD, +201146703107, elzimbily@aun.edu.eg
About this study
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:
- To determine the percentage of Wilms tumors among pediatric cancers.
- To study the outcome of patients with Wilms tumor treated according to SIOP Umbrella protocol (1).
- 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:
- History and physical examination at presentation:
- Demographic data as: Age, sex, residence and date of diagnosis.
- 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:
- 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
- Assess myocardial contractility before starting cardiotoxic chemotherapy.
- Detect the presence of tumor in the inferior vena cava or right atrium
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:
- 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.
- 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)
- Conditions
- Wilms Tumor
- Keywords
- wilms, incidence, outcome
- Medical subject headings
- Wilms Tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall-survival (OS)
will be calculated from date of diagnosis to last date of follow up or date of death for any cause
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start15 Jun 2020
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wilms TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Shefa Al-orman Children Cancer Hospital, Assiut University
- Responsible party
- Principal investigator, Mahmoud Motaz Elzembely, South Egypt Cancer Institute
- Investigators
- Mahmoud Elzembely, MD, Principal investigator, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288802
- Sponsor's protocol ID
- 04-2023-200647
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 33258687van 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Wilms Tumors Among Patients of Shefa Al-Orman Children Cancer Hospital
- ClinicalTrials.gov ID
- NCT06288802
- Acronym / sponsor ID
- 04-2023-200647
- Conditions
- Wilms Tumor
- Keywords
- wilms, incidence, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Collaborators
- Shefa Al-orman Children Cancer Hospital, Assiut University
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the percentage of Wilms tumors among pediatric cancers.
- To study the outcome of patients with Wilms tumor treated according to SIOP Umbrella protocol (1).
- 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:
- History and physical examination at presentation:
- Demographic data as: Age, sex, residence and date of diagnosis.
- 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:
- 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
- Assess myocardial contractility before starting cardiotoxic chemotherapy.
- Detect the presence of tumor in the inferior vena cava or right atrium
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:
- 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.
- 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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- Children and young adolescene younger than 18 years of age admitted and treated at Shefa Al-orman Children Cancer Hospital during the study period
Key exclusion criteria (1 listed)
- Patients aged older than 18 years old, died early at presentation before starting chemotherapy, patients with non-Wilms renal tumors, relapsed renal tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 33258687Basch 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.
- Results publication: PubMed 29089605van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Elzembely, MD principal investigator
South Egypt Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wilms Tumor, run by South Egypt Cancer Institute at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Elzembely, MD (+201146703107, elzimbily@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall-survival (OS) (time frame: from date of diagnosis to last date of follow up or date of death for any cause). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06288802, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.