Childhood Malignant Ovarian Germ Cell Tumor Clinical Trial
Official title:
Molecular Epidemiology of Pediatric Germ Cell Tumors
Verified date | October 2017 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 932 |
Est. completion date | August 4, 2016 |
Est. primary completion date | August 4, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 19 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Childrens Oncology Group | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Up to 5 years | |
Secondary | 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. | Up to 5 years |
Status | Clinical Trial | Phase | |
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