Epigenetic and Metabolomic Changes in Childhood Cancer Survivors
NCT ID: NCT03866707
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
7 participants
OBSERVATIONAL
2019-02-25
2020-05-16
Brief Summary
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Detailed Description
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Specific Aim 1. What are the epigenetic differences between children treated for childhood cancers and healthy controls matched for age, sex, ethnicity, geographic region, and tanner stage.
Specific Aim 2. Compare the metabolomic differences between children treated for childhood cancers and healthy controls matched for age, sex, ethnicity, geographic region, and tanner stage.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Interventions
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One-time blood draw
Subjects will have a one-time blood draw of 5-10mL. Quantity of blood drawn for study and routine care will not exceed the maximum safe blood volume for subject size.
Evaluation of CpG methylation sites will be completed using the MethylationEPIC BeadChip (Infinium) microarray. This covers over 850,000 CpG methylation sites and is available in the investigator's Genomics Core Facility. Dr. Langefeld has analyzed numerous methylation studies, both array-based and next generation sequencing.
Metabolomic analysis will be performed by mass spectrometry when funds are available.
Evaluation of CpG methylation
Evaluation of CpG methylation sites will be completed using the MethylationEPIC BeadChip (Infinium) microarray.
Metabolomic analysis
Metabolomic analysis will be performed by mass spectrometry when funds are available.
Eligibility Criteria
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Inclusion Criteria
* Diseases which will be eligible include, high risk or very high risk acute lymphoblastic leukemia, acute myeloid leukemia, Hodgkin lymphoma, non-Hodgkin lymphoma, sarcomas.
Healthy controls:
• Healthy controls are defined as children ages 1-18 years old who are free from diseases or medical conditions that might be affected by or have an impact on this research study. Healthy controls will be matched with patients for age, sex, ethnicity, geographic region, and tanner stage, since it is known that these factors can affect the epigenetic signature of an individual. Controls will already be having blood drawn as part of their routine care.
Exclusion Criteria
• Patients who have received a bone marrow transplant will not be eligible.
Healthy controls:
• Age, sex, ethnicity, geographic region, and tanner stage matched controls with any acute or chronic disease will be excluded.
1 Year
18 Years
ALL
Yes
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Kevin Buckley, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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CCCWFU 01118
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00048882
Identifier Type: -
Identifier Source: org_study_id