Childhood Germ Cell TumorNCT01572467
Studying Genes in Samples From Younger Patients With Ovarian or Testicular Sex Cord Stromal Tumors
An observational study of Childhood Germ Cell Tumor and Leydig Cell Tumor, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. PURPOSE: This research trial is studying genes in tumor samples from younger patients with ovarian or testicular sex cord stromal tumors. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Childhood Germ Cell Tumor, Leydig Cell Tumor, Ovarian Cancer
- What is being tested?
- RNA analysis, gene expression analysis and mutation analysis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Jul 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 Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients With Ovarian or Testicular Sex Cord Stromal Tumors
DISEASE CHARACTERISTICS:
- Fixed and frozen tissue samples from the ATBR01 B1 tissue bank and from the International Pleuropulmonary Blastoma Registry, Children's Hospital of Boston, and Massachusetts General Hospital
- Tissue samples from patients diagnosed with:
- Ovarian
- Sertoli-Leydig cell tumor
- Juvenile granulosa cell tumor
- Adult granulosa cell tumor
- Gynandroblastoma
- Sex cord stromal tumor with annular tubules
- Sex cord stromal tumor, undifferentiated
- Sertoli tumor
- Leydig tumor
- Testicular:
- Granulosa cell tumor
- Sertoli tumor
- Leydig tumor
- Sertoli-Leydig
- Undifferentiated stromal tumor
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: DICER1 Mutations and miRNA in Ovarian and Testicular Sex Cord Stromal Tumors of Childhood
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.
PURPOSE: This research trial is studying genes in tumor samples from younger patients with ovarian or testicular sex cord stromal tumors.
Read the detailed description
OBJECTIVES:
- To assess the role of DICER1 mutations and miRNA pathways in the etiology and progression of ovarian or testicular sex cord stromal tumors.
OUTLINE: Archived tumor tissue samples are analyzed for D1CER1 mutation and mRNA expression by reverse-transcriptase polymerase chain reaction (RT-PCR) and laser micro dissector. Results are then correlated with medical data, including age at diagnosis, diagnosis, pathology report, presenting symptoms, family history, treatment, outcome, and length of follow-up, when available.
- Conditions
- Childhood Germ Cell Tumor, Leydig Cell Tumor, Ovarian Cancer
- Being tested
- RNA analysis, gene expression analysis, mutation analysis, reverse transcriptase-polymerase chain reaction, laboratory biomarker analysis
- Keywords
- Leydig cell tumor, ovarian stromal cancer, childhood malignant testicular germ cell tumor, childhood malignant ovarian germ cell tumor
- Medical subject headings
- Leydig Cell Tumor, Ovarian Neoplasms, Testicular Neoplasms, Ovarian Germ Cell Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA analysisGenetic
gene expression analysisGenetic
mutation analysisGenetic
reverse transcriptase-polymerase chain reactionGenetic
laboratory biomarker analysisOther
medical chart reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between DICER1 mutations and miRNA pathways with outcomes using descriptive analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJul 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dana A. Hill, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572467
- Sponsor's protocol ID
- ARAR12B2
- Other IDs
- COG-ARAR12B2, NCI-2012-00721, ARAR12B2
- Status last verified
- Jul 2016
- First submitted
- 5 Apr 2012
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DICER1 Mutations and miRNA in Ovarian and Testicular Sex Cord Stromal Tumors of Childhood
- ClinicalTrials.gov ID
- NCT01572467
- Acronym / sponsor ID
- ARAR12B2
- Conditions
- Childhood Germ Cell Tumor, Leydig Cell Tumor, Ovarian Cancer
- Keywords
- Leydig cell tumor, ovarian stromal cancer, childhood malignant testicular germ cell tumor, childhood malignant ovarian germ cell tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2012
- Primary completion
- Jul 2016 (actual)
- First posted
- 6 Apr 2012 (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 tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.
PURPOSE: This research trial is studying genes in tumor samples from younger patients with ovarian or testicular sex cord stromal tumors.
Detailed description
OBJECTIVES:
- To assess the role of DICER1 mutations and miRNA pathways in the etiology and progression of ovarian or testicular sex cord stromal tumors.
OUTLINE: Archived tumor tissue samples are analyzed for D1CER1 mutation and mRNA expression by reverse-transcriptase polymerase chain reaction (RT-PCR) and laser micro dissector. Results are then correlated with medical data, including age at diagnosis, diagnosis, pathology report, presenting symptoms, family history, treatment, outcome, and length of follow-up, when available.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients With Ovarian or Testicular Sex Cord Stromal Tumors
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 |
|---|---|---|
| RNA analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| mutation analysis | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| laboratory biomarker analysis | Other | – |
| medical chart review | Other | – |
Primary outcome
Correlation between DICER1 mutations and miRNA pathways with outcomes using descriptive analysis
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 14 Jul 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.
Dana A. Hill, MD principal investigator
Children's National Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Germ Cell Tumor and Leydig Cell Tumor, run by Children's Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 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?
Correlation between DICER1 mutations and miRNA pathways with outcomes using descriptive analysis. 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 14 Jul 2016.