An observational study in Childhood Malignant Ovarian Germ Cell Tumor, Childhood Malignant Testicular Germ Cell Tumor and Ovarian Choriocarcinoma, sponsored by Children's Oncology Group. Completed at 1 site in United States. Open to participants aged Up to 19 Years. Per ClinicalTrials.gov, last updated 2019-01-07.
Sponsored by Children's Oncology Group · Observational
This research trial studies deoxyribonucleic acid (DNA) samples from younger patients with germ cell tumor and their parents or siblings. Studying samples of tumor tissue and saliva from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
OBJECTIVES:
I. To evaluate associations between genetic variation and pediatric germ cell tumor (GCT) using a case-parent triad design to identify variants in four genes, KITLG, SPRY4, BAK1, and DMRT1, associated with pediatric GCT.
II. To evaluate associations between genetic variation and pediatric GCT using a case-parent triad design to include targeted genotyping of single nucleotide polymorphisms (SNPs) in selected key pathways essential for normal in utero germ cell development, specifically genes involved in survival of germ cells during migration, apoptosis, and cell cycle control.
III. To explore inter- and intratumoral heterogeneity in DNA methylation by tumor histology.
OUTLINE: This is a multicenter study.
Patients and parents or siblings undergo saliva sample collection. DNA extracted from saliva samples and from patients' archived tumor tissue samples is genotyped and analyzed by methylation arrays, including methylation-specific polymerasechain reaction (PCR) (pyrosequencing) assays. Genetic variation between pediatric germ cell tumors and parent or sibling is also analyzed. Patients' and family members' health history, demographics, and environmental exposures are collected by questionnaires or telephone interviews. Medical history, such as chronic conditions, prescribed medications and congenital abnormalities, including cryptorchidism, is also collected. Birth characteristics of the child, including birth weight and gestational age, are also captured.
Inclusion Criteria:
The patient must have at least one biological parent alive and willing to participate
Patients and parents or siblings undergo saliva sample collection. DNA extracted from saliva samples and from patients' archived tumor tissue samples is genotyped and analyzed by methylation arrays, including methylation-specific PCR (pyrosequencing) assays. Genetic variation between pediatric germ cell tumors and parent or sibling is also analyzed. Patients' and family members' health history, demographics, and environmental exposures are collected by questionnaires or telephone interviews. Medical history, such as chronic conditions, prescribed medications and congenital abnormalities, including cryptorchidism, is also collected. Birth characteristics of the child, including birth weight and gestational age, are also captured.
Other: Laboratory Biomarker Analysis · Other: Questionnaire Administration
Correlative studies
Ancillary studies
Pediatric GCT associated with genetic susceptibility
Will be modeled using a Poisson regression. A likelihood ratio test determines the statistical significance.
Time frame: Up to 5 years
List of genes that distinguish between the three most common histologic subtypes of pediatric GCT: yolk sac tumor, teratoma, and germinoma
A permutation based Chi-Square test for categorical covariates or a permutation based Kruskal-Wallis test (continuous risk factors) will be used.
Time frame: Up to 5 years
Validation of array results by pyrosequencing
A standard case-only approach evaluating differences in methylation by histology, age and gender will be done using chi-square and ANOVA.
Time frame: Up to 5 years
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Children's Oncology Group