Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: September 9, 2011
Last updated: May 17, 2016
Last verified: May 2016

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.

Condition Intervention
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Ovarian Cancer
Testicular Germ Cell Tumor
Genetic: DNA methylation analysis
Genetic: RNA analysis
Genetic: mutation analysis
Genetic: nucleic acid sequencing
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Genomic Signatures of Malignant Germ Cell Tumor Progression: A Retrospective Study of Banked Specimens

Resource links provided by NLM:

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival
  • Genomic prognostic signatures associated with GCTS
  • Genetic variants that contribute to GCTS pathogenesis
  • Expression of various forms of RNA

Estimated Enrollment: 90
Study Start Date: October 2011
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients registered on the Children Oncology Group (COG) Germ Cell Tumor Protocols.


  • 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


  • Not specified


  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01433224

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: James F. Amatruda, MD, PhD Simmons Cancer Center
  More Information

Responsible Party: Children's Oncology Group Identifier: NCT01433224     History of Changes
Other Study ID Numbers: AGCT11B2
COG-AGCT11B2 ( Other Identifier: Children's Oncology Group )
AGCT11B2 ( Other Identifier: Children's Oncology Group )
NCI-2011-03456 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: September 9, 2011
Last Updated: May 17, 2016

Keywords provided by Children's Oncology Group:
recurrent childhood malignant germ cell tumor
recurrent extragonadal germ cell tumor
recurrent malignant testicular germ cell tumor
recurrent ovarian germ cell tumor

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders processed this record on April 26, 2017