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Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression

Genomic Signatures of Malignant Germ Cell Tumor Progression: A Retrospective Study of Banked Specimens

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01433224
Enrollment
90
Registered
2011-09-13
Start date
2011-10-31
Completion date
2016-05-31
Last updated
2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor

Keywords

recurrent childhood malignant germ cell tumor, recurrent extragonadal germ cell tumor, recurrent malignant testicular germ cell tumor, recurrent ovarian germ cell tumor

Brief summary

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer. PURPOSE: This research trial studies samples from younger patients with malignant germ cell tumor progression.

Detailed description

OBJECTIVES: * Explore inter-tumoral heterogeneity in DNA methylation by tumor histology. * Determine the genomic methylation pattern in the tumors. * Correlate methylation pattern with tumor histology and clinical characteristics. * Carry out exome capture and massively parallel sequencing on selected germ cell tumors (GCTs) and matched normal tissue. * Perform exome capture and Solexa sequencing on a selected set of GCTs. * Validate candidate mutations in an independent set of tumors. * Determine the expression profile of mRNAs, lincRNAs and microRNAs in the tumors using RNA Seq. OUTLINE: Archived blood and tumor tissue samples are analyzed for genomic methylation pattern, exome capture and sequencing, and candidate mutations by methylation-specific PCR techniques, single nucleotide polymorphism (SNP) arrays, and Solexa sequencing methods. Results are validated by using pyrosequencing assays and primer-extension assays. Methylation pattern is also associated with each patient's tumor histology and clinical data.

Interventions

GENETICDNA methylation analysis
GENETICRNA analysis
GENETICmutation analysis
GENETICnucleic acid sequencing
GENETICpolymerase chain reaction
GENETICpolymorphism analysis
OTHERlaboratory biomarker analysis
OTHERmedical chart review

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Tumor and blood specimens from patients registered on the Children Oncology Group (COG) Germ Cell Tumor Protocols, and from other study sites for non-COG patients, including Children's Medical Center, Dallas and the Dana-Farber Cancer Institute, Boston * Patients' clinical data PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Design outcomes

Primary

MeasureTime frame
Event-free survival
Genomic prognostic signatures associated with GCTS
Genetic variants that contribute to GCTS pathogenesis
Expression of various forms of RNA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026