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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03947346
Other study ID # 19-160
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 9, 2019
Est. completion date May 2025

Study information

Verified date March 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 20 Years
Eligibility 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 Design


Intervention

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-ß1, IL-18 and KIM-1). Serum BUN, creatinine, and cystatin-C will be assessed using serum samples drawn for routine clinical care.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary indicators of renal injury urine collected from the first morning void will be used to assess urine creatinine 2 years