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OpenTrials
Completed

NCT Number: NCT01433224

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNA methylation analysis

Genetic

RNA analysis

Genetic

mutation analysis

Genetic

nucleic acid sequencing

Genetic

polymerase chain reaction

Genetic

polymorphism analysis

Genetic

laboratory biomarker analysis

Other

medical chart review

Other

Primary outcomes

  1. Event-free survival

  2. Genomic prognostic signatures associated with GCTS

  3. Genetic variants that contribute to GCTS pathogenesis

  4. Expression of various forms of RNA

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Sep 13, 2011
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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