NCT06153147 KIdney aNd blooD prESsure ouTcomes in Childhood Cancer Survivors (CCS)
| NCT ID | NCT06153147 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Childhood Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-01-05 |
| Primary Completion | 2029-10-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-01-05 with a primary completion date of 2029-10-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Pre-cancer severe CKD and/or previous kidney transplant * \>19 years old at 3 years after cancer therapy completion
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06153147 clinical trial?
This trial is open to participants of all sexes, up to 19 Years, studying Childhood Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06153147 currently recruiting?
Yes, NCT06153147 is actively recruiting participants. Contact the research team at michael.zappitelli@sickkids.ca for enrollment information.
Where is the NCT06153147 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06153147 clinical trial?
NCT06153147 is sponsored by The Hospital for Sick Children. The trial plans to enroll 500 participants.
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