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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Childhood Malignant Ovarian Germ Cell Tumor
  • Childhood Malignant Testicular Germ Cell Tumor
  • Choriocarcinoma
  • Germinoma
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Ovarian Choriocarcinoma
  • Ovarian Embryonal Carcinoma
  • Ovarian Mixed Germ Cell Tumor
  • Ovarian Neoplasms
  • Ovarian Teratoma
  • Ovarian Yolk Sac Tumor
  • Seminoma
  • Teratoma
  • Testicular Choriocarcinoma
  • Testicular Embryonal Carcinoma
  • Testicular Neoplasms
  • Testicular Seminoma
  • Testicular Teratoma
  • Testicular Yolk Sac Tumor

NCT number NCT01434355
Study type Observational
Source Children's Oncology Group
Contact
Status Completed
Phase
Start date November 1, 2011
Completion date August 4, 2016

See also
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Completed NCT00467051 - Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors Phase 2
Completed NCT00053352 - Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors Phase 3
Completed NCT00897442 - Collecting Tumor Samples From Patients With Gynecological Tumors N/A