Biomarkers of Renal Dysfunction in Neuroblastoma Survivors

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03947346
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Anticipated Duration (Months): 47.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroblastoma Survivors	Other: Urine sample

Study Design

• Study Type: Observational
• Actual Enrollment: 28 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Biomarkers of Renal Dysfunction in Neuroblastoma Survivors
• Actual Study Start Date: May 9, 2019
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. indicators of renal injury [2 years]

   urine collected from the first morning void will be used to assess urine creatinine

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT03947346
• Other Study ID Numbers: 19-160
• First Posted: May 13, 2019
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Memorial Sloan Kettering Cancer Center: Kidney Function; Biomarkers; 19-160
• Additional relevant MeSH terms: Neuroblastoma; Renal Insufficiency

Study Results

No Results Posted as of Aug 15, 2022