DNA Analysis in Samples From Younger Patients With Germ Cell Tumors and Their Parents or Siblings

NCT01434355 | Completed

• 4 other identifiers: AEPI10N1NCI-2011-03464CDR0000711070COG-AEPI10N1
• Study Type: observational
• Target: 932
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Malignant Ovarian Germ Cell Tumor; Childhood Malignant Testicular Germ Cell Tumor; Ovarian Choriocarcinoma; Ovarian Embryonal Carcinoma; Ovarian Mixed Germ Cell Tumor; Ovarian Teratoma; Ovarian Yolk Sac Tumor; Testicular Choriocarcinoma; Testicular Embryonal Carcinoma; Testicular Seminoma; Testicular Teratoma; Testicular Yolk Sac Tumor

Outcome Measures

Primary Outcomes (1)

• Pediatric GCT associated with genetic susceptibility

  Will be modeled using a Poisson regression. A likelihood ratio test determines the statistical significance.

  Up to 5 years

Secondary Outcomes (2)

• List of genes that distinguish between the three most common histologic subtypes of pediatric GCT: yolk sac tumor, teratoma, and germinoma

  Up to 5 years

• Validation of array results by pyrosequencing

  Up to 5 years

Study Arms (1)

Correlative studies

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

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Correlative studies

Questionnaire Administration OTHER

Ancillary studies

Correlative studies

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

You may qualify if:

• The patient is enrolled on COG-ACCRN07
• The patient has a primary diagnosis of germ cell tumor (GCT) including germinoma (ICCC 9060-9065) teratoma (9080-9084), embryonal carcinoma (9070-9072), yolk sac tumor (9071),choriocarcinoma (9100, 9103, 9104), and mixed GCT (9085, 9101, 9102, 9105) in all sites including the brain and central nervous system and registered with Children's Oncology Group (COG) by a North American member institution
• The patient must be diagnosed with a germ cell tumor between July 1, 2008 and December 31, 2015
• The patient must be \< 20 years of age at the time of diagnosis
• The patient must have at least one biological parent alive and willing to participate
• In the event that one case parent cannot contribute DNA, a case sibling, defined as the biological brother or sister of the study subject, may donate instead
• All questionnaire respondents must understand English or Spanish
• Concomitant treatment on a therapeutic trial is not required

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Childrens Oncology Group

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and tissue

MeSH Terms

Conditions

Ovarian Germ Cell Cancer; Testicular Neoplasms; Teratoma, Ovarian; Seminoma; Teratoma, Testicular; Endodermal Sinus Tumor

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Mesonephroma

Study Officials

• Jenny Poynter

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 14, 2011
• Study Start: November 1, 2011
• Primary Completion: August 4, 2016
• Study Completion: August 4, 2016
• Last Updated: January 7, 2019

Record last verified: 2017-10

Locations

US (1)