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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01433224
First received: September 9, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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: mutation analysis
Genetic: nucleic acid sequencing
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]
  • Genomic prognostic signatures associated with GCTS [ Designated as safety issue: No ]
  • Genetic variants that contribute to GCTS pathogenesis [ Designated as safety issue: No ]

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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT01433224

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: James F. Amatruda, MD, PhD Simmons Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01433224     History of Changes
Other Study ID Numbers: CDR0000710847, COG-AGCT11B2
Study First Received: September 9, 2011
Last Updated: September 9, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
Neoplasms, Germ Cell and Embryonal
Ovarian Neoplasms
Testicular Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Diseases, Male
Genital Neoplasms, Female
Genital Neoplasms, Male
Gonadal Disorders
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Testicular Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014