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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01433224
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : May 18, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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.

Condition or disease Intervention/treatment
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

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.

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Genomic Signatures of Malignant Germ Cell Tumor Progression: A Retrospective Study of Banked Specimens
Study Start Date : October 2011
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01433224

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

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) )
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 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