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

This study is currently recruiting participants.
Verified October 2017 by Children's Oncology Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT01434355
First Posted: September 14, 2011
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose
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.

Condition Intervention
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 Other: laboratory biomarker analysis Other: questionnaire administration

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Molecular Epidemiology of Pediatric Germ Cell Tumors

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Pediatric GCT associated with genetic susceptibility [ Time Frame: Up to 5 years ]
    Will be modeled using a Poisson regression. A likelihood ratio test determines the statistical significance.


Secondary Outcome Measures:
  • List of genes that distinguish between the three most common histologic subtypes of pediatric GCT: yolk sac tumor, teratoma, and germinoma [ Time Frame: Up to 5 years ]
    A permutation based Chi-Square test for categorical covariates or a permutation based Kruskal-Wallis test (continuous risk factors) will be used.

  • Validation of array results by pyrosequencing [ Time Frame: Up to 5 years ]
    A standard case-only approach evaluating differences in methylation by histology, age and gender will be done using chi-square and ANOVA.


Biospecimen Retention:   Samples With DNA
Saliva and tissue

Estimated Enrollment: 932
Study Start Date: November 2011
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Correlative studies
Other: questionnaire administration
Ancillary studies

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a primary diagnosis of germ cell tumor (GCT) meeting other criteria.
Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434355


Locations
United States, California
Children's Oncology Group Recruiting
Monrovia, California, United States, 91006-3776
Contact: Jenny Poynter, PhD    612-625-4232    poynt006@umn.edu   
Principal Investigator: Jenny Poynter, PhD         
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jenny Poynter, PhD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01434355     History of Changes
Other Study ID Numbers: AEPI10N1
NCI-2011-03464 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AEPI10N1 ( Other Identifier: Children's Oncology Group )
AEPI10N1 ( Other Identifier: Children's Oncology Group )
AEPI10N1 ( Other Identifier: CTEP )
First Submitted: September 13, 2011
First Posted: September 14, 2011
Last Update Posted: October 9, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Neoplasms, Germ Cell and Embryonal
Germinoma
Ovarian Neoplasms
Teratoma
Testicular Neoplasms
Carcinoma, Embryonal
Endodermal Sinus Tumor
Seminoma
Choriocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Genital Neoplasms, Male
Genital Diseases, Male
Testicular Diseases
Mesonephroma
Trophoblastic Neoplasms
Adenocarcinoma
Pregnancy Complications, Neoplastic
Pregnancy Complications