Epigenetic and Metabolomic Changes in Childhood Cancer Survivors

Terminated

• Conditions: Childhood Cancer

• Registration Number: NCT03866707
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

The purpose of this research study is to try and identify markers in childhood cancer survivors to help predict if they will develop late effects from their cancer treatment.

Detailed Description

This is a pilot study to obtain preliminary data that will be used to apply for a larger grant to fund the full study with an adequate sample size for analysis.

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.

Study Timeline

• Study Start: 2019-02-25
• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-07
• Primary Completion: 2020-05-16
• Study Completion: 2020-05-16
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Childhood cancer survivors age 1-18 years old who received intensive treatment which included anthracycline and/or alkylating agent chemotherapy.
• 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.

Read More

Exclusion Criteria

Cancer survivors:

• 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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epigenetic Testing	Over 9 months	Baseline and follow-up differences (predictor) in CpG methylation at sites on the EPIC array will be compared between subjects and controls (outcomes). Samples will be evaluated using the Infinium Methylation EPIC BeadChip microarray. This evaluates over 850,000 CpG methylation sites. The proportion of methylation for each site is based on the ratio of the fluorescence intensity of the methylated versus the combined methylated and unmethylated probes (referred to as the β value), and will be determined with GenomeStudio (Illumina, Inc.). For analysis, all β values will be converted to M values, where M is the log2 ratio of the methylated probe intensity to the unmethylated probe intensity.
Metabolomic testing	Over 9 months	Metabolic profiling will be done on serum using ultrahigh-performance liquid-phase chromatography and gas-chromatography separation, coupled with tandem mass spectrometry (UHPLC/MS/MS2 and GC/MS, respectively) at Metabolon, Inc. (Durham, NC, USA) using established procedures and technology. (10) samples will be collected at three time points based on disease type and will be flash frozen in liquid nitrogen after collection and stored at -80°C to ensure sample stability.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States