Clinical trial NCT03866707: Epigenetic and Metabolomic Changes in Childhood Cancer Survivors
Official title: Epigenetic and Metabolomic Changes in Childhood Cancer Survivors as a Late Effect of Treatment - a Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Childhood Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators propose to evaluate 8 patients who have been treated for childhood cancer and are at least 6 months off therapy. Because methylation patterns are known to change in different populations, 8 control patients matched for age, sex, and tanner stage will also be evaluated. Because of their under representation in clinical research, initially the investigators will recruit cancer survivors and controls of Caucasian Hispanic ethnicity from the same geographic region (i.e., Piedmont region of North Carolina).

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.

Eligibility 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.

Primary outcomes:
measure: Epigenetic Testing
timeFrame: Over 9 months
measure: Metabolomic testing
timeFrame: Over 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kevin Buckley, MD
role: PRINCIPAL_INVESTIGATOR
References: