Pediatric Central Nervous System TumorNCT06054295
Somatic Mosaicism in Twins Discordant for Childhood Cancer
An observational study of Pediatric Central Nervous System Tumor and Central Nervous System Tumor, run by Children's Oncology Group at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Central Nervous System Tumor, Central Nervous System Tumor, Discordant Twin
- What is being tested?
- Biospecimen collection and Questionnaire Administration
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Newly diagnosed same sex twins with pediatric central nervous system (CNS) tumors
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Jenny Poynter, PhD, 612-625-4232, poynt006@umn.edu
About this study
Official title: Somatic Mosaicism in Twins Discordant for Childhood Cancer: a Pilot Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Pediatric Central Nervous System Tumor, Central Nervous System Tumor, Discordant Twin, Somatic Mutation
- Being tested
- Biospecimen collection, Questionnaire Administration
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen collectionOther
Collection of both blood and saliva samples from participants at the time of study enrollment
Questionnaire AdministrationOther
The brief questionnaire will assess health history, demographics, environmental exposures, family history of cancer, and birth characteristics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Biospecimen collection; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the prevalence of somatic mosaicism in classic cancer-associated genes in monozygotic (MZ) twins discordant for childhood brain tumors.
Sequence blood and saliva DNA samples from 25 MZ twin pairs using a panel of 94 known cancer associated genes.
Measured: Up to 18 months
Secondary outcomes (1)
Compare the profile of mutations detected in DNA extracted from pre- and post-treatment blood samples from a subset of CNS tumor patients.
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
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start3 Jun 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Central Nervous System TumorStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jenny Poynter, PhD, Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054295
- Sponsor's protocol ID
- AEPI22N2
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatic Mosaicism in Twins Discordant for Childhood Cancer: a Pilot Study
- ClinicalTrials.gov ID
- NCT06054295
- Acronym / sponsor ID
- AEPI22N2
- Conditions
- Pediatric Central Nervous System Tumor, Central Nervous System Tumor, Discordant Twin, Somatic Mutation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative | – | Other: Biospecimen collection, Other: Questionnaire AdministrationTwins 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Newly diagnosed same sex twins with pediatric central nervous system (CNS) tumors
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen collectionCollection of both blood and saliva samples from participants at the time of study enrollment | Other | Ancillary-Correlative |
| Questionnaire AdministrationThe brief questionnaire will assess health history, demographics, environmental exposures, family history of cancer, and birth characteristics. | Other | Ancillary-Correlative |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jenny Poynter, PhD study chair
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Central Nervous System Tumor and Central Nervous System Tumor, run by Children's Oncology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Poynter, PhD ((612) 625-4232, poynt006@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.