To Determine the Cumulative Incidence of AKI Using KDIGO Criteria in Pediatric Patients With Malignancy in South Egypt Cancer Institute (SECI)NCT06081608
Acute Kidney Injury Among Pediatric Cancer Patients At South Egypt Cancer Institute
An observational study of To Determine the Cumulative Incidence of AKI Using KDIGO Criteria in Pediatric Patients With Malignancy in South Egypt Cancer Institute (SECI), run by Assiut University.
Trial summary
Cancer is the second most frequent cause of premature death in children. The incidence of pediatric cancer varies by region and country, but it is generally considered rare with an estimated 300,000 new cases diagnosed worldwide. Read more about this study
- Who is it for?
- Ages 30 days to 18 years
- Conditions the study is for
- To Determine the Cumulative Incidence of AKI Using KDIGO Criteria in Pediatric Patients With Malignancy in South Egypt Cancer Institute (SECI)
- What is being tested?
- kidney function test
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Sep 2024
- How long will I take part?
- 12 Months
- 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 30 days to 18 years
- All sexes
- Child, Adult
Study population: •Children of both sexes (aged from 1 month to 18 years at diagnosis)
Who may be able to join
- • Children of both sexes (aged from 1 month to 18 years at diagnosis)
- Patients with either hematological malignancies or solid tumors admitted to the Paediatric Oncology and Haematological Malignancies Department
Who cannot join
- Children who had an unconfirmed cancer diagnosis.
- Children more than 18 years at diagnosis.
- Children with preexisting chronic kidney disease (CKD) that defined as the presence of structural or functional kidney damage that persist over minimum of three month
- The patient underwent hematopoietic stem cell transplantation. Patients with 1 s.Cr level.
- Patient underwent renal transplant.
About this study
Cancer is the second most frequent cause of premature death in children. The incidence of pediatric cancer varies by region and country, but it is generally considered rare with an estimated 300,000 new cases diagnosed worldwide. Acute kidney injury in pediatric cancer patients refers to the sudden and often temporary loss of renal function, which can lead to a variety of complications if not treated correctly.
Read the detailed description
- Primary: To determine the cumulative incidence of AKI using KDIGO criteria in pediatric patients with malignancy in South Egypt Cancer Institute (SECI)
- Secondary:
- Incidence of Hospital-acquired and community-acquired AKI
- Asses the risk factors of the incidence of AKI
- To determine in-hospital outcome (time to in-hospital death, length of hospital stay, and time to kidney recovery) of AKI.
This is a prospective study that will be carried out in the Paediatric Oncology and Haematological Malignancies Department including patients diagnosed with malignant tumours and hospitalized from 1st April 2023 for one year duration.
- Being tested
- kidney function test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kidney function testDiagnostic test
blood sample for kidney function test
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the cumulative incidence of AKI using KDIGO criteria in pediatric patients with malignancy in South Egypt Cancer Institute (SECI)
Measured: from November 2023 till November 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine the Cumulative Incidence of AKI Using KDIGO Criteria in Pediatric Patients With Malignancy in South Egypt Cancer Institute (SECI)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Amir Fathy Riad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081608
- Sponsor's protocol ID
- 639
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury Among Pediatric Cancer Patients At South Egypt Cancer Institute
- ClinicalTrials.gov ID
- NCT06081608
- Acronym / sponsor ID
- 639
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 13 Oct 2023 (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.
Cancer is the second most frequent cause of premature death in children. The incidence of pediatric cancer varies by region and country, but it is generally considered rare with an estimated 300,000 new cases diagnosed worldwide. Acute kidney injury in pediatric cancer patients refers to the sudden and often temporary loss of renal function, which can lead to a variety of complications if not treated correctly.
Detailed description
- Primary: To determine the cumulative incidence of AKI using KDIGO criteria in pediatric patients with malignancy in South Egypt Cancer Institute (SECI)
- Secondary:
- Incidence of Hospital-acquired and community-acquired AKI
- Asses the risk factors of the incidence of AKI
- To determine in-hospital outcome (time to in-hospital death, length of hospital stay, and time to kidney recovery) of AKI.
This is a prospective study that will be carried out in the Paediatric Oncology and Haematological Malignancies Department including patients diagnosed with malignant tumours and hospitalized from 1st April 2023 for one year duration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- •Children of both sexes (aged from 1 month to 18 years at diagnosis)
Key inclusion criteria (2 listed)
- • Children of both sexes (aged from 1 month to 18 years at diagnosis)
Key exclusion criteria (5 listed)
- Children who had an unconfirmed cancer diagnosis.
- Children more than 18 years at diagnosis.
- Children with preexisting chronic kidney disease (CKD) that defined as the presence of structural or functional kidney damage that persist over minimum of three month
- The patient underwent hematopoietic stem cell transplantation. Patients with 1 s.Cr level.
- Patient underwent renal transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kidney function testblood sample for kidney function test | Diagnostic test | – |
Primary outcome
To determine the cumulative incidence of AKI using KDIGO criteria in pediatric patients with malignancy in South Egypt Cancer Institute (SECI)
Time frame: from November 2023 till November 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of To Determine the Cumulative Incidence of AKI Using KDIGO Criteria in Pediatric Patients With Malignancy in South Egypt Cancer Institute (SECI), run by Assiut University.
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 2 inclusion and 5 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 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the cumulative incidence of AKI using KDIGO criteria in pediatric patients with malignancy in South Egypt Cancer Institute (SECI) (time frame: from November 2023 till November 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2023.