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出境医 / 临床实验 / Biomarkers of Renal Dysfunction in Neuroblastoma Survivors
Biomarkers of Renal Dysfunction in Neuroblastoma Survivors
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 |
|---|---|
| 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 |
| Estimated Primary Completion Date : | May 2021 |
| Estimated Study Completion Date : | May 2021 |
Arms 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.
|
Outcome Measures
Primary Outcome Measures :
- indicators of renal injury [ Time Frame: 2 years ]urine collected from the first morning void will be used to assess urine creatinine
Biospecimen Retention: Samples Without DNA
Urine
Eligibility Criteria
| Ages Eligible for Study: | up to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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.
Criteria
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
| United States, New York | |
| 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 |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 9, 2019 | ||||||||
| First Posted Date | May 13, 2019 | ||||||||
| Last Update Posted Date | August 26, 2020 | ||||||||
| Actual Study Start Date | May 9, 2019 | ||||||||
| Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
indicators of renal injury [ Time Frame: 2 years ] urine collected from the first morning void will be used to assess urine creatinine
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Biomarkers of Renal Dysfunction in Neuroblastoma Survivors | ||||||||
| Official Title | Biomarkers of Renal Dysfunction in Neuroblastoma Survivors | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description:
Urine
|
||||||||
| 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. | ||||||||
| Condition | Neuroblastoma Survivors | ||||||||
| 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-β1, IL-18 and KIM-1). Serum BUN, creatinine, and cystatin-C will be assessed using serum samples drawn for routine clinical care.
|
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| Study Groups/Cohorts | 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.
Intervention: Other: Urine sample
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Active, not recruiting | ||||||||
| Actual Enrollment |
28 | ||||||||
| Original Estimated Enrollment |
80 | ||||||||
| Estimated Study Completion Date | May 2021 | ||||||||
| Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | up to 20 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03947346 | ||||||||
| Other Study ID Numbers | 19-160 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Memorial Sloan Kettering Cancer Center | ||||||||
| Study Sponsor | Memorial Sloan Kettering Cancer Center | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Memorial Sloan Kettering Cancer Center | ||||||||
| Verification Date | August 2020 | ||||||||
