Biomarkers of Renal Dysfunction in Neuroblastoma Survivors

The main purpose of this study is to learn more about biomarkers of kidney function in the blood and urine of neuroblastoma survivors. A biomarker is a biological molecule found in blood, urine, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition.

Study Overview

• Status: Completed
• Conditions: Neuroblastoma Survivors
• Intervention / Treatment: Other: Urine sample

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Childhood cancer survivors followed by the Pediatric Long-Term Follow-Up (LTFU) Program will be recruited for the current study.

Description

Inclusion Criteria:

• Diagnosis of neuroblastoma between 0-18 years of age
• < 21 years of age at time of study enrollment
• Two or more years from completion of systemic chemotherapy and/or radiation therapy

Exclusion Criteria:

• Patients treated with observation only
• Patients with multiple primary cancers

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
survivors of neuroblastoma treated with nephrotoxic therapy; Upon enrollment, all subjects will receive a urine collection kit by mail. Participants will bring in a first-morning urine specimen on the day of their routinely scheduled long-term follow-up visit, and will then have an additional blood and urine sample drawn with their other clinical care labs upon arrival to MSK.	Other: Urine sample; The urine collected from the first morning void will be used to assess urine creatinine and microalbumin. The fresh urine specimen will be analyzed for novel urinary biomarkers of (urinary NGAL, TGF-β1, IL-18 and KIM-1). Serum BUN, creatinine, and cystatin-C will be assessed using serum samples drawn for routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
indicators of renal injury	urine collected from the first morning void will be used to assess urine creatinine	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Danielle Friedman, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): July 15, 2025
• Study Completion (Actual): July 15, 2025

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Biomarkers; Kidney Function; 19-160
• Additional Relevant MeSH Terms: Urogenital Diseases; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neuroblastoma; Renal Insufficiency
• Other Study ID Numbers: 19-160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No