Epigenetic and Metabolomic Changes in Childhood Cancer Survivors as a Late Effect of Treatment - a Pilot Study

Epigenetic and Metabolomic Changes in Childhood Cancer Survivors

Sponsors

Lead sponsor: Wake Forest University Health Sciences

Source 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.

Overall Status Recruiting
Start Date February 25, 2019
Completion Date September 2020
Primary Completion Date June 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Epigenetic Testing Over 9 months
Metabolomic testing Over 9 months
Enrollment 16
Condition
Intervention

Intervention type: Other

Intervention name: One-time blood draw

Description: 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.

Intervention type: Other

Intervention name: Evaluation of CpG methylation

Description: Evaluation of CpG methylation sites will be completed using the MethylationEPIC BeadChip (Infinium) microarray.

Intervention type: Other

Intervention name: Metabolomic analysis

Description: Metabolomic analysis will be performed by mass spectrometry when funds are available.

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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.

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.

Gender: All

Minimum age: 1 Year

Maximum age: 18 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Kevin Buckley, MD Principal Investigator Wake Forest University Health Sciences
Location
facility status contact contact_backup investigator
Comprehensive Cancer Center of Wake Forest University Recruiting Principal Investigator 336-716-2011 [email protected] Kevin Buckley, MD Principal Investigator
Location Countries

United States

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Study Design Info

Observational model: Case-Control

Time perspective: Prospective

Source: ClinicalTrials.gov