- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06054295
Somatic Mosaicism in Twins Discordant for Childhood Cancer
Somatic Mosaicism in Twins Discordant for Childhood Cancer: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jenny Poynter, PhD
- Phone Number: (612) 625-4232
- Email: poynt006@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Contact:
- Jenny Poynter, PhD
- Phone Number: 612-625-4232
- Email: poynt006@umn.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
Collection of both blood and saliva samples from participants at the time of study enrollment
The brief questionnaire will assess health history, demographics, environmental exposures, family history of cancer, and birth characteristics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Jenny Poynter, PhD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEPI22N2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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