Clinical Trials Directory

Trials / Terminated

TerminatedNCT03866707

Epigenetic and Metabolomic Changes in Childhood Cancer Survivors

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

Status
Terminated
Phase
Study type
Observational
Enrollment
7 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
1 Year – 18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHEROne-time blood drawSubjects 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.
OTHEREvaluation of CpG methylationEvaluation of CpG methylation sites will be completed using the MethylationEPIC BeadChip (Infinium) microarray.
OTHERMetabolomic analysisMetabolomic analysis will be performed by mass spectrometry when funds are available.

Timeline

Start date
2019-02-25
Primary completion
2020-05-16
Completion
2020-05-16
First posted
2019-03-07
Last updated
2023-12-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03866707. Inclusion in this directory is not an endorsement.