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Somatic Mosaicism in Twins Discordant for Childhood Cancer

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ClinicalTrials.gov Identifier: NCT06054295
Recruitment Status : Recruiting
First Posted : September 26, 2023
Last Update Posted : October 10, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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.

Condition or disease Intervention/treatment
Pediatric Central Nervous System Tumor Central Nervous System Tumor Discordant Twin Somatic Mutation Other: Biospecimen collection Other: Questionnaire Administration

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Somatic Mosaicism in Twins Discordant for Childhood Cancer: a Pilot Study
Actual Study Start Date : September 29, 2023
Estimated Primary Completion Date : October 5, 2025
Estimated Study Completion Date : December 31, 2025

Group/Cohort Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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 ]
    Sequence blood and saliva DNA samples from 25 MZ twin pairs using a panel of 94 known cancer associated genes.


Secondary Outcome Measures :
  1. Compare the profile of mutations detected in DNA extracted from pre- and post-treatment blood samples from a subset of CNS tumor patients. [ Time Frame: Up to 18 months ]
    Determine the frequency of somatic mosaicism in twins discordant for CNS tumors. Will use an exact test of proportions to determine whether the affected twin is more likely to have a mosaic mutation. The comparison of pre-treatment and post-treatment samples in the CNS tumor cases will include a descriptive comparison of the mutations identified in each sample



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed same sex twins with pediatric central nervous system (CNS) tumors
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06054295


Contacts
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Contact: Jenny Poynter, PhD (612) 625-4232 poynt006@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Jenny Poynter, PhD    612-625-4232    poynt006@umn.edu   
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Jenny Poynter, PhD University of Minnesota
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT06054295    
Other Study ID Numbers: AEPI22N2
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases