Childhood CancerKINDEST-CCSNCT06153147
KIdney aNd blooD prESsure ouTcomes in Childhood Cancer Survivors (CCS)
An observational study of Childhood Cancer and Chronic Kidney Diseases, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Background: Childhood cancer survivors (CCS) are at elevated risk of chronic health conditions. Chemotherapies can cause recurrent acute kidney injury which may progress to kidney fibrosis, chronic kidney disease (CKD) or hypertension (HTN). CCS surviving to adulthood are at ≥3 times the risk (vs. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Childhood Cancer, Chronic Kidney Diseases, Hypertension
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2024to 31 Dec 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Observational cohort study of CCS at 5 Ontario child cancer centres
Who may be able to join
- 3 years ± 6 months after therapy for first cancer
- Received high-risk therapy for first cancer, as defined by the Canadian Oncology Group (COG) as alkylating agents; platinums; abdominal or total body radiation; high dose methotrexate; stem cell transplant; nephrectomy; or other therapy which may be known to possibly cause late kidney and/or BP effects.
Who cannot join
- Pre-cancer severe CKD and/or previous kidney transplant
- >19 years old at 3 years after cancer therapy completion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Hospital For Sick Children
Toronto, Ontario, M5G 1E8
Yasmine Hejri-Rad, BA, 416-813-7910 ext. 309031, yasmine.hejri-rad@sickkids.ca
Salma Abrahim, MSc, salma.abrahim@sickkids.ca
About this study
Official title: KIdney aNd blooD prESsure ouTcomes in Childhood Cancer Survivors (CCS): Prospective Study
Background: Childhood cancer survivors (CCS) are at elevated risk of chronic health conditions. Chemotherapies can cause recurrent acute kidney injury which may progress to kidney fibrosis, chronic kidney disease (CKD) or hypertension (HTN). CCS surviving to adulthood are at ≥3 times the risk (vs. non-CCS) for CKD, HTN and lower quality of life. However, the timing of CKD and HTN onset in CCS completing cancer therapy in childhood remains unclear.
Guidelines provide recommendations on managing post-cancer therapy effects in CCS, but they lack specificity on kidney testing content, frequency and complications. This discord is largely due to knowledge gaps on which CCS develop CKD or HTN after cancer therapy, when outcomes occur and their severity. Existing work has shown in select patients, CKD and HTN in CCS likely begins in the first 5 years post-cancer therapy and that the burden is significant. With robust data on CKD and HTN, international CCS follow-up guidelines can be optimized to include detailed and actionable recommendations on kidney and blood pressure monitoring and treatment.
Read the detailed description
Significant improvements in childhood cancer survival rates have come at the cost of an increase in chronic health conditions. Childhood cancer survivors (CCS) often experience chronic kidney disease (CKD) and hypertension (HTN), yet data on the onset and severity of these diseases in the primary years after childhood cancer therapy is unclear. Both CKD and HTN are major treatable cardiovascular risk factors, and the knowledge gap in the first 5 years after therapy impedes the creation of evidence-based guidelines and early intervention plans.
Currently, the Children's Oncology Group international guidelines, which are used to identify and manage therapy effects in CCS, lack information on CKD testing and appropriate measures. With appropriate treatment, CKD and HTN complications are treatable.
In 500 CCS at high risk for blood pressure (BP) and late kidney effects due to cancer therapy, we will determine the prevalence of HTN and CKD at 3 and 5 years after cancer therapy, and the extent to which eGFR, albuminuria and BP worsen from 3 to 5 years after therapy. In addition, we will assess whether acute kidney injury during cancer therapy and cardiometabolic risk factors are associated with these outcomes.
Based on the evidence from the study, we hope to improve current CCS kidney and BP guidelines to advise on appropriate treatments and measures for HTN and CKD. As CCS are vulnerable to cardiovascular disease, addressing CKD and HTN complications will improve their overall quality of life.
- Conditions
- Childhood Cancer, Chronic Kidney Diseases, Hypertension, Acute Kidney Injury, Nephrotoxicity
- Medical subject headings
- Neoplasms, Renal Insufficiency, Chronic, Hypertension, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Late effects after nephrotoxic chemotherapies. | 3 and 5 year kidney and blood pressure effects after cancer therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Chronic Kidney Disease (CKD) based on eGFR (using an equation) at 3 years post cancer therapy
CKD: Per Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Measured: 3 years +/- 6 months after cancer therapy end
Prevalence of Chronic Kidney Disease (CKD) based on eGFR (using an equation) at 5 years post cancer therapy
CKD: Per Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Measured: 5 years +/- 6 months after cancer therapy end
Prevalence of Hypertension (HTN) from office blood pressure (vis blood pressure machine) at 3 years post cancer therapy
Defined by 2017 American Academy of Pediatrics (AAP) guidelines
Measured: 3 years +/- 6 months after cancer therapy end
Prevalence of Hypertension (HTN) using Ambulatory Blood Pressure Measurement (ABPM) at 5 years post cancer therapy
The presence of either ambulatory hypertension or masked hypertension
Measured: 5 years +/- 6 months after cancer therapy end
Change in markers of kidney health (eGFR)(using an equation) between 3 and 5 years post cancer therapy
Change in eGFR in milliliter (mL) /min/1.73m2
Measured: Change from 3 to 5 years in eGFR
Change in markers of kidney health (Albuminuria) (using lab values) between 3 and 5 years post cancer therapy
Change in albuminuria in mg/g
Measured: Change from 3 to 5 years in Albuminuria
Change in markers of kidney health (Proteinuria) (using Lab values) between 3 and 5 years post cancer therapy
Change in proteinuria in mg/mmol
Measured: Change from 3 to 5 years in Proteinuria
Change in markers of cardiovascular health (using blood tests) between 3 and 5 years post cancer therapy
Change in BP percentile as per 2017 American Academy of Pediatrics (AAP) guidelines
Measured: Change from 3 to 5 years
Secondary outcomes (1)
Impact of Acute Kidney Injury (AKI) and Cardiometabolic risk factors (using blood work) at baseline on CKD outcomes
CKD: Per Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Measured: At baseline for independent factors on CKD outcomes at 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start5 Jan 2024
- Primary completion25 Oct 2029 (estimated)
- Study completion31 Dec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Zappitelli, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153147
- Sponsor's protocol ID
- OCREB 4177
- Acronym
- KINDEST-CCS
- Status last verified
- Apr 2024
- First submitted
- 4 Nov 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KIdney aNd blooD prESsure ouTcomes in Childhood Cancer Survivors (CCS): Prospective Study
- ClinicalTrials.gov ID
- NCT06153147
- Acronym / sponsor ID
- KINDEST-CCS / OCREB 4177
- Conditions
- Childhood Cancer, Chronic Kidney Diseases, Hypertension, Acute Kidney Injury, Nephrotoxicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 25 Oct 2029 (estimated)
- Study completion
- 31 Dec 2039 (estimated)
- First posted
- 1 Dec 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.
Background: Childhood cancer survivors (CCS) are at elevated risk of chronic health conditions. Chemotherapies can cause recurrent acute kidney injury which may progress to kidney fibrosis, chronic kidney disease (CKD) or hypertension (HTN). CCS surviving to adulthood are at ≥3 times the risk (vs. non-CCS) for CKD, HTN and lower quality of life. However, the timing of CKD and HTN onset in CCS completing cancer therapy in childhood remains unclear.
Guidelines provide recommendations on managing post-cancer therapy effects in CCS, but they lack specificity on kidney testing content, frequency and complications. This discord is largely due to knowledge gaps on which CCS develop CKD or HTN after cancer therapy, when outcomes occur and their severity. Existing work has shown in select patients, CKD and HTN in CCS likely begins in the first 5 years post-cancer therapy and that the burden is significant. With robust data on CKD and HTN, international CCS follow-up guidelines can be optimized to include detailed and actionable recommendations on kidney and blood pressure monitoring and treatment.
Detailed description
Significant improvements in childhood cancer survival rates have come at the cost of an increase in chronic health conditions. Childhood cancer survivors (CCS) often experience chronic kidney disease (CKD) and hypertension (HTN), yet data on the onset and severity of these diseases in the primary years after childhood cancer therapy is unclear. Both CKD and HTN are major treatable cardiovascular risk factors, and the knowledge gap in the first 5 years after therapy impedes the creation of evidence-based guidelines and early intervention plans.
Currently, the Children's Oncology Group international guidelines, which are used to identify and manage therapy effects in CCS, lack information on CKD testing and appropriate measures. With appropriate treatment, CKD and HTN complications are treatable.
In 500 CCS at high risk for blood pressure (BP) and late kidney effects due to cancer therapy, we will determine the prevalence of HTN and CKD at 3 and 5 years after cancer therapy, and the extent to which eGFR, albuminuria and BP worsen from 3 to 5 years after therapy. In addition, we will assess whether acute kidney injury during cancer therapy and cardiometabolic risk factors are associated with these outcomes.
Based on the evidence from the study, we hope to improve current CCS kidney and BP guidelines to advise on appropriate treatments and measures for HTN and CKD. As CCS are vulnerable to cardiovascular disease, addressing CKD and HTN complications will improve their overall quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Late effects after nephrotoxic chemotherapies. | – | –3 and 5 year kidney and blood pressure effects after cancer therapy. |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Observational cohort study of CCS at 5 Ontario child cancer centres
Key inclusion criteria (2 listed)
- 3 years ± 6 months after therapy for first cancer
- Received high-risk therapy for first cancer, as defined by the Canadian Oncology Group (COG) as alkylating agents; platinums; abdominal or total body radiation; high dose methotrexate; stem cell transplant; nephrectomy; or other therapy which may be known to possibly cause late kidney and/or BP effects.
Key exclusion criteria (2 listed)
- Pre-cancer severe CKD and/or previous kidney transplant
- >19 years old at 3 years after cancer therapy completion
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
Prevalence of Chronic Kidney Disease (CKD) based on eGFR (using an equation) at 3 years post cancer therapy
Time frame: 3 years +/- 6 months after cancer therapy end
CKD: Per Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Prevalence of Chronic Kidney Disease (CKD) based on eGFR (using an equation) at 5 years post cancer therapy
Time frame: 5 years +/- 6 months after cancer therapy end
CKD: Per Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Prevalence of Hypertension (HTN) from office blood pressure (vis blood pressure machine) at 3 years post cancer therapy
Time frame: 3 years +/- 6 months after cancer therapy end
Defined by 2017 American Academy of Pediatrics (AAP) guidelines
Prevalence of Hypertension (HTN) using Ambulatory Blood Pressure Measurement (ABPM) at 5 years post cancer therapy
Time frame: 5 years +/- 6 months after cancer therapy end
The presence of either ambulatory hypertension or masked hypertension
Change in markers of kidney health (eGFR)(using an equation) between 3 and 5 years post cancer therapy
Time frame: Change from 3 to 5 years in eGFR
Change in eGFR in milliliter (mL) /min/1.73m2
Change in markers of kidney health (Albuminuria) (using lab values) between 3 and 5 years post cancer therapy
Time frame: Change from 3 to 5 years in Albuminuria
Change in albuminuria in mg/g
Change in markers of kidney health (Proteinuria) (using Lab values) between 3 and 5 years post cancer therapy
Time frame: Change from 3 to 5 years in Proteinuria
Change in proteinuria in mg/mmol
Change in markers of cardiovascular health (using blood tests) between 3 and 5 years post cancer therapy
Time frame: Change from 3 to 5 years
Change in BP percentile as per 2017 American Academy of Pediatrics (AAP) guidelines
1 secondary outcome
Impact of Acute Kidney Injury (AKI) and Cardiometabolic risk factors (using blood work) at baseline on CKD outcomes
Time frame: At baseline for independent factors on CKD outcomes at 3 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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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.
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 Childhood Cancer and Chronic Kidney Diseases, run by The Hospital for Sick Children at 1 site in Canada.
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 2 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: looking for participants now, as of the sponsor's last update on 17 Apr 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Zappitelli, MD (4168137605 ext. 304077, michael.zappitelli@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Chronic Kidney Disease (CKD) based on eGFR (using an equation) at 3 years post cancer therapy (time frame: 3 years +/- 6 months after cancer therapy end). The study lists 8 primary outcomes in all. 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 17 Apr 2024.