Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression
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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 |
- 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) |
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 |
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 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:
|
Ovarian Neoplasms Neoplastic Processes Neoplasms, Germ Cell and Embryonal Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Pathologic Processes Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 23, 2013