Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression

NCT01433224 | Completed

• 3 other identifiers: AGCT11B2COG-AGCT11B2NCI-2011-03456
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer. PURPOSE: This research trial studies samples from younger patients with malignant germ cell tumor progression.

Conditions

Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Ovarian Cancer; Testicular Germ Cell Tumor

Keywords

recurrent childhood malignant germ cell tumor; recurrent extragonadal germ cell tumor; recurrent malignant testicular germ cell tumor; recurrent ovarian germ cell tumor

Outcome Measures

Primary Outcomes (4)

• Event-free survival

• Genomic prognostic signatures associated with GCTS

• Genetic variants that contribute to GCTS pathogenesis

• Expression of various forms of RNA

Interventions

DNA methylation analysis GENETIC

RNA analysis GENETIC

mutation analysis GENETIC

nucleic acid sequencing GENETIC

polymerase chain reaction GENETIC

polymorphism analysis GENETIC

laboratory biomarker analysis OTHER

medical chart review OTHER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients registered on the Children Oncology Group (COG) Germ Cell Tumor Protocols.

DISEASE CHARACTERISTICS: * Tumor and blood specimens from patients registered on the Children Oncology Group (COG) Germ Cell Tumor Protocols, and from other study sites for non-COG patients, including Children's Medical Center, Dallas and the Dana-Farber Cancer Institute, Boston * Patients' clinical data PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Ovarian Neoplasms; Testicular Germ Cell Tumor; Testicular Neoplasms

Interventions

DNA Methylation; Base Sequence; Polymerase Chain Reaction; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases

Intervention Hierarchy (Ancestors)

Methylation; Alkylation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Genetic Phenomena; Molecular Structure; Genetic Structures; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; DNA Fingerprinting

Study Officials

• James F. Amatruda, MD, PhD

  Simmons Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 13, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2016-05