- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06054295
Somatic Mosaicism in Twins Discordant for Childhood Cancer
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Jenny Poynter, PhD
- Telefonnummer: (612) 625-4232
- E-mail: poynt006@umn.edu
Studiesteder
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55455
- Rekruttering
- University of Minnesota
-
Kontakt:
- Jenny Poynter, PhD
- Telefonnummer: 612-625-4232
- E-mail: poynt006@umn.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Newly diagnosed same sex twins with pediatric central nervous system (CNS) tumors
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: FAMILY_BASED
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Compare the prevalence of somatic mosaicism in classic cancer-associated genes in monozygotic (MZ) twins discordant for childhood brain tumors.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Compare the profile of mutations detected in DNA extracted from pre- and post-treatment blood samples from a subset of CNS tumor patients.
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Jenny Poynter, PhD, University of Minnesota
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AEPI22N2
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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