Adrenocortical CarcinomaNCT01528956
Studying Genes in Samples From Younger Patients With Adrenocortical Tumor
An observational study of Adrenocortical Carcinoma, run by Children's Oncology Group.
Trial summary
RATIONALE: Studying samples of blood and tumor 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. PURPOSE: This research trial studies genes in samples from younger patients with adrenocortical tumor. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Adrenocortical Carcinoma
- What is being tested?
- DNA methylation analysis, RNA analysis and gene expression analysis
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients enrolled on COG-ARAR0332
DISEASE CHARACTERISTICS:
- Banked tumor and blood samples obtained from patients enrolled on COG-ARAR0332 in North America and Brazil
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Using New Approaches for Genomics Studies in Pediatric Adrenocortical Tumors: Whole Genome Sequencing; Deep Sequencing; miRNA; methDNA and SNP 6.0
RATIONALE: Studying samples of blood and tumor 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.
PURPOSE: This research trial studies genes in samples from younger patients with adrenocortical tumor.
Read the detailed description
OBJECTIVES:
- To perform whole-genome sequencing, deep sequencing, micro RNA analysis, methylation status, copy number variation analysis, and single-nucleotide polymorphisms (SNPs) analysis in pediatric adrenocortical tumors and compare those results to those of the same patient's normal cells.
OUTLINE: Archived tumor and blood samples are analyzed for whole-genome sequencing, deep sequencing, micro RNA , methylation status, copy variation, and single-nucleotide polymorphisms. Results are then compared with patients' normal cells.
- Conditions
- Adrenocortical Carcinoma
- Being tested
- DNA methylation analysis, RNA analysis, gene expression analysis, nucleic acid sequencing, polymorphism analysis
- Keywords
- adrenocortical carcinoma
- Medical subject headings
- Adrenocortical Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA methylation analysisGenetic
RNA analysisGenetic
gene expression analysisGenetic
nucleic acid sequencingGenetic
polymorphism analysisGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of genetic factors affecting adrenocortical tumors
Comprehensive catalog of altered genes in adrenocortical samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenocortical CarcinomaStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gerard Zambetti, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528956
- Sponsor's protocol ID
- ARAR12B1
- Other IDs
- COG-ARAR12B1, CDR0000724572, ARAR12B1, NCI-2012-00244
- Status last verified
- May 2016
- First submitted
- 5 Feb 2012
- 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
- Using New Approaches for Genomics Studies in Pediatric Adrenocortical Tumors: Whole Genome Sequencing; Deep Sequencing; miRNA; methDNA and SNP 6.0
- ClinicalTrials.gov ID
- NCT01528956
- Acronym / sponsor ID
- ARAR12B1
- Conditions
- Adrenocortical Carcinoma
- Keywords
- adrenocortical carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2012
- Primary completion
- May 2016 (actual)
- First posted
- 8 Feb 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 blood and tumor 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.
PURPOSE: This research trial studies genes in samples from younger patients with adrenocortical tumor.
Detailed description
OBJECTIVES:
- To perform whole-genome sequencing, deep sequencing, micro RNA analysis, methylation status, copy number variation analysis, and single-nucleotide polymorphisms (SNPs) analysis in pediatric adrenocortical tumors and compare those results to those of the same patient's normal cells.
OUTLINE: Archived tumor and blood samples are analyzed for whole-genome sequencing, deep sequencing, micro RNA , methylation status, copy variation, and single-nucleotide polymorphisms. Results are then compared with patients' normal cells.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients enrolled on COG-ARAR0332
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 | – |
| gene expression analysis | Genetic | – |
| nucleic acid sequencing | Genetic | – |
| polymorphism analysis | Genetic | – |
Primary outcome
Identification of genetic factors affecting adrenocortical tumors
Comprehensive catalog of altered genes in adrenocortical samples
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.
Gerard Zambetti, PhD principal investigator
St. Jude Children's Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenocortical Carcinoma, 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 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?
Identification of genetic factors affecting adrenocortical tumors. The study lists 2 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.