Somatic Mosaicism in Twins Discordant for Childhood Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A - 18 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06054295
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Children's Oncology Group
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jenny Poynter, PhD
Principal Investigator Affiliation	University of Minnesota
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pediatric Central Nervous System Tumor, Central Nervous System Tumor, Discordant Twin, Somatic Mutation

Additional Details

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.

Arms & Interventions

Arms

: Ancillary-Correlative

Twins with CNS tumors, identified through the Children's Oncology Group's Project:EveryChild (PEC) registry, will have both blood and saliva samples collected at the time of study enrollment.

Interventions

Other: - Biospecimen collection

Collection of both blood and saliva samples from participants at the time of study enrollment

Other: - Questionnaire Administration

The brief questionnaire will assess health history, demographics, environmental exposures, family history of cancer, and birth characteristics.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55455

Site Contact

Jenny Poynter, PhD

[email protected]

612-625-4232

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