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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01433224
Other study ID # AGCT11B2
Secondary ID COG-AGCT11B2AGCT
Status Completed
Phase N/A
First received September 9, 2011
Last updated May 17, 2016
Start date October 2011
Est. completion date May 2016

Study information

Verified date May 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Intervention

Genetic:
DNA methylation analysis

RNA analysis

mutation analysis

nucleic acid sequencing

polymerase chain reaction

polymorphism analysis

Other:
laboratory biomarker analysis

medical chart review


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary Event-free survival No
Primary Genomic prognostic signatures associated with GCTS No
Primary Genetic variants that contribute to GCTS pathogenesis No
Primary Expression of various forms of RNA No
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