Clinical trial NCT06054295: Somatic Mosaicism in Twins Discordant for Childhood Cancer
Official title: Somatic Mosaicism in Twins Discordant for Childhood Cancer: a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Central Nervous System Tumor
Central Nervous System Tumor
Discordant Twin
Somatic Mutation
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-09-26
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed same sex twins with pediatric central nervous system (CNS) tumors

Brief summary: Somatic mosaicism in cancer associated genes is one potential explanation for discordance in childhood cancer that has not been fully explored to date. This pilot study will focus on twins with central nervous system (CNS) tumors who are identified through the Children's Oncology Group's Project: EveryChild (PEC) registry or volunteer.

Detailed description: PRIMARY OBJECTIVES:

I. To conduct a descriptive study of same sex twins (MZ and DZ) discordant for childhood CNS tumors identified through the Children's Oncology Group Project:EveryChild registry.

II. To compare the prevalence of somatic mosaicism in classic cancer-associated genes in monozygotic (MZ) twins discordant for childhood brain tumors. In our pilot study, we will sequence blood and saliva DNA samples from 25 MZ twin pairs using a panel of 94 known cancer associated genes.

SECONDARY OBJECTIVES:

I. To compare the profile of mutations detected in DNA extracted from pre- and post-treatment blood samples from a subset of CNS tumor patients. The purpose of this aim is to ensure that differences in somatic mosaicism detected in twin pairs are not caused by cancer therapy.

Outline:

Twins with CNS tumors will undergo blood and saliva DNA samples with the goal is to learn more about genetic differences that may lead to CNS tumor development.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patient with CNS tumor or have recurrent disease and enrolled on APEC14B1.
* Patient must have same sex twin. Note: (history of) treatment on a COG therapeutic trial is not required.
* Patients must be diagnosed at \< 19 years of age at the time of diagnosis.
* A family is eligible to participate if the twin with the CNS tumor is deceased but has a blood sample banked through APEC14B1.
* All patients and/or their parents or legal guardians must provide informed consent. Assent will be obtained for participants between the ages of 8-17 years.
* All institutional, FDA, and NCI requirements for human studies must be met.

Primary outcomes:
measure: Compare the prevalence of somatic mosaicism in classic cancer-associated genes in monozygotic (MZ) twins discordant for childhood brain tumors.
timeFrame: Up to 18 months
Secondary outcomes:
measure: Compare the profile of mutations detected in DNA extracted from pre- and post-treatment blood samples from a subset of CNS tumor patients.
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jenny Poynter, PhD
role: STUDY_CHAIR
References: