KIdney aNd blooD prESsure ouTcomes in Childhood Cancer Survivors (CCS)

NCT06153147 | Recruiting

• 1 other identifier: OCREB 4177
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cancer; Chronic Kidney Diseases; Hypertension; Acute Kidney Injury; Nephrotoxicity

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  At baseline for independent factors on CKD outcomes at 3 and 5 years

Study Arms (1)

Late effects after nephrotoxic chemotherapies.

3 and 5 year kidney and blood pressure effects after cancer therapy.

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Observational cohort study of CCS at 5 Ontario child cancer centres

You may qualify if:

• 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.

You may not qualify if:

• Pre-cancer severe CKD and/or previous kidney transplant
• \>19 years old at 3 years after cancer therapy completion

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital For Sick Children

Toronto, Ontario, M5G 1E8, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

5 milliliter (mL) of whole blood using Serum Separation Tubes (SST) 30 milliliter (mL) of urine 24 hour and first morning urine

MeSH Terms

Conditions

Neoplasms; Renal Insufficiency, Chronic; Hypertension; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Michael Zappitelli, MD

CONTACT

4168137605; michael.zappitelli@sickkids.ca

Yasmine Hejri-Rad, BA

CONTACT

416-813-7605; yasmine.hejri-rad@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Nephrologist and Senior Scientist

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 1, 2023
• Study Start: January 5, 2024
• Primary Completion (Estimated): October 25, 2029
• Study Completion (Estimated): December 31, 2039
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

CA (1)