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

Ovarian Cancer Clinical Trial

Official title:

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

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

Related Conditions & MeSH terms

• Childhood Germ Cell Tumor
• Extragonadal Germ Cell Tumor
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Ovarian Cancer
• Testicular Germ Cell Tumor
• Testicular Neoplasms

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