Childhood Germ Cell TumorNCT01433224
Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression
An observational study of Childhood Germ Cell Tumor and Extragonadal Germ Cell Tumor, run by Children's Oncology Group.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Ovarian Cancer
- What is being tested?
- DNA methylation analysis, RNA analysis and mutation analysis
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
About this study
Official title: Genomic Signatures of Malignant Germ Cell Tumor Progression: A Retrospective Study of Banked Specimens
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.
Read the detailed description
OBJECTIVES:
- Explore inter-tumoral heterogeneity in DNA methylation by tumor histology.
- Determine the genomic methylation pattern in the tumors.
- Correlate methylation pattern with tumor histology and clinical characteristics.
- Carry out exome capture and massively parallel sequencing on selected germ cell tumors (GCTs) and matched normal tissue.
- Perform exome capture and Solexa sequencing on a selected set of GCTs.
- Validate candidate mutations in an independent set of tumors.
- Determine the expression profile of mRNAs, lincRNAs and microRNAs in the tumors using RNA Seq.
OUTLINE: Archived blood and tumor tissue samples are analyzed for genomic methylation pattern, exome capture and sequencing, and candidate mutations by methylation-specific PCR techniques, single nucleotide polymorphism (SNP) arrays, and Solexa sequencing methods. Results are validated by using pyrosequencing assays and primer-extension assays. Methylation pattern is also associated with each patient's tumor histology and clinical data.
- Conditions
- Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor
- Being tested
- DNA methylation analysis, RNA analysis, mutation analysis, nucleic acid sequencing, polymerase chain reaction
- Keywords
- recurrent childhood malignant germ cell tumor, recurrent extragonadal germ cell tumor, recurrent malignant testicular germ cell tumor, recurrent ovarian germ cell tumor
- Medical subject headings
- Ovarian Neoplasms, Testicular Germ Cell Tumor, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA methylation analysisGenetic
RNA analysisGenetic
mutation analysisGenetic
nucleic acid sequencingGenetic
polymerase chain reactionGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
medical chart reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Genomic prognostic signatures associated with GCTS
Genetic variants that contribute to GCTS pathogenesis
Expression of various forms of RNA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James F. Amatruda, MD, PhD, Principal investigator, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433224
- Sponsor's protocol ID
- AGCT11B2
- Other IDs
- COG-AGCT11B2, AGCT11B2, NCI-2011-03456
- Status last verified
- May 2016
- First submitted
- 9 Sep 2011
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Signatures of Malignant Germ Cell Tumor Progression: A Retrospective Study of Banked Specimens
- ClinicalTrials.gov ID
- NCT01433224
- Acronym / sponsor ID
- AGCT11B2
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Explore inter-tumoral heterogeneity in DNA methylation by tumor histology.
- Determine the genomic methylation pattern in the tumors.
- Correlate methylation pattern with tumor histology and clinical characteristics.
- Carry out exome capture and massively parallel sequencing on selected germ cell tumors (GCTs) and matched normal tissue.
- Perform exome capture and Solexa sequencing on a selected set of GCTs.
- Validate candidate mutations in an independent set of tumors.
- Determine the expression profile of mRNAs, lincRNAs and microRNAs in the tumors using RNA Seq.
OUTLINE: Archived blood and tumor tissue samples are analyzed for genomic methylation pattern, exome capture and sequencing, and candidate mutations by methylation-specific PCR techniques, single nucleotide polymorphism (SNP) arrays, and Solexa sequencing methods. Results are validated by using pyrosequencing assays and primer-extension assays. Methylation pattern is also associated with each patient's tumor histology and clinical data.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients registered on the Children Oncology Group (COG) Germ Cell Tumor Protocols.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | – |
Primary outcome
Event-free survival
Genomic prognostic signatures associated with GCTS
Genetic variants that contribute to GCTS pathogenesis
Expression of various forms of RNA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James F. Amatruda, MD, PhD principal investigator
Simmons Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Germ Cell Tumor and Extragonadal Germ Cell Tumor, run by Children's Oncology Group.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.