Recruiting

Observational Study

Sponsor:

Children's Oncology Group

Code:

NCT06054295

Conditions

Pediatric Central Nervous System Tumor

Central Nervous System Tumor

Discordant Twin

Somatic Mutation

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Biospecimen collection

Questionnaire Administration

Study Details

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.

Conditions

Pediatric Central Nervous System Tumor

Central Nervous System Tumor

Discordant Twin

Somatic Mutation

Study ID

NCT06054295

Start date

Jun 3, 2024

Status verified date

Dec, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

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

Biospecimen collection

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

Questionnaire Administration

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

Primary outcome measure

  • Compare the prevalence of somatic mosaicism in classic cancer-associated genes in monozygotic (MZ) twins discordant for childhood brain tumors. [ Time Frame: Up to 18 months ]

Central Contacts and Locations

Central contacts

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

More Information

Sponsor

Children's Oncology Group

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Oncology Group on 2025-12-16.