Childhood HepatoblastomaNCT01336881
Biomarkers in Tissue Samples From Young Patients With Liver Cancer
An observational study of Childhood Hepatoblastoma and Stage I Childhood Liver Cancer, run by Children's Oncology Group at 1 site in United States.
Trial summary
This research trial is studying biomarkers in tissue samples from young patients with liver cancer. Studying samples of 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Childhood Hepatoblastoma, Stage I Childhood Liver Cancer, Stage II Childhood Liver Cancer
- What is being tested?
- RNA analysis, gene expression analysis and microarray analysis
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2011
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Young patients with liver cancer
Who may be able to join
- Diagnosis of hepatoblastoma or other liver cancer including the following subtypes:
- Pure fetal histology
- Transitional histology
- Small cell undifferentiated histology
- Participated on the Children's Oncology Group (COG) clinical trials
- Available data and tumor samples
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Monrovia, California, 91006-3776
About this study
Official title: Genetics and Biology of Liver Tumorigenesis in Children
This research trial is studying biomarkers in tissue samples from young patients with liver cancer. Studying samples of 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To identify biomarker signatures associated with hepatoblastoma subtypes (by microRNA array profiling), and their potential correlation with liver developmental stages as well as outcome.
II. To correlate expression array data with copy number array data.
SECONDARY OBJECTIVES:
- To carry out a focused sequencing interrogation of amplified or deleted genomic regions as well as genes in key cell pathways involved in embryonic development and/or stem cell signaling pathways for which preliminary data suggests involvement in the pathogenesis of hepatoblastoma.
II. To perform whole exome sequencing in a subset of tumors.
OUTLINE: This is a multicenter study.
Archived tumor tissue samples are analyzed for hepatoblastoma and other liver tumor biomarkers by microRNA array profiling and exome sequencing. Results are then compared with patients' clinical data.
- Conditions
- Childhood Hepatoblastoma, Stage I Childhood Liver Cancer, Stage II Childhood Liver Cancer, Stage III Childhood Liver Cancer, Stage IV Childhood Liver Cancer
- Being tested
- RNA analysis, gene expression analysis, microarray analysis, nucleic acid sequencing, diagnostic laboratory biomarker analysis
- Medical subject headings
- Hepatoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA analysisGenetic
gene expression analysisGenetic
microarray analysisGenetic
Also called gene expression profiling
nucleic acid sequencingGenetic
Also called Gene Sequencing, Molecular Biology, Nucleic Acid Sequencing
diagnostic laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Correlative (tissue analysis) | Archived tumor tissue samples are analyzed for hepatoblastoma and other liver tumor biomarkers by microRNA array profiling and exome sequencing. Results are then compared with patients' clinical data. Receives: Genetic: RNA analysis; Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: nucleic acid sequencing; Other: diagnostic laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers associated with hepatoblastoma subtypes and cancer stages
Measured: Baseline
Secondary outcomes (2)
Genes involved in embryonic development and/or stem cell signaling pathways for which preliminary data suggests involvement in the pathogenesis of hepatoblastoma
Measured: Baseline
Exome sequencing
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood HepatoblastomaStudies 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
- Time perspective
- Retrospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gail Tomlinson, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336881
- Sponsor's protocol ID
- AHEP11B1
- Other IDs
- NCI-2011-02852, COG-AHEP11B1, CDR0000698720
- Status last verified
- May 2016
- First submitted
- 15 Apr 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
- Genetics and Biology of Liver Tumorigenesis in Children
- ClinicalTrials.gov ID
- NCT01336881
- Acronym / sponsor ID
- AHEP11B1
- Conditions
- Childhood Hepatoblastoma, Stage I Childhood Liver Cancer, Stage II Childhood Liver Cancer, Stage III Childhood Liver Cancer, Stage IV Childhood Liver Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2011
- Primary completion
- Jul 2011 (actual)
- First posted
- 18 Apr 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.
This research trial is studying biomarkers in tissue samples from young patients with liver cancer. Studying samples of 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.
Detailed description
PRIMARY OBJECTIVES:
- To identify biomarker signatures associated with hepatoblastoma subtypes (by microRNA array profiling), and their potential correlation with liver developmental stages as well as outcome.
II. To correlate expression array data with copy number array data.
SECONDARY OBJECTIVES:
- To carry out a focused sequencing interrogation of amplified or deleted genomic regions as well as genes in key cell pathways involved in embryonic development and/or stem cell signaling pathways for which preliminary data suggests involvement in the pathogenesis of hepatoblastoma.
II. To perform whole exome sequencing in a subset of tumors.
OUTLINE: This is a multicenter study.
Archived tumor tissue samples are analyzed for hepatoblastoma and other liver tumor biomarkers by microRNA array profiling and exome sequencing. Results are then compared with patients' clinical data.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Correlative (tissue analysis) | – | Genetic: RNA analysis, Genetic: gene expression analysis, Genetic: microarray analysis, Genetic: nucleic acid sequencing, Other: diagnostic laboratory biomarker analysisArchived tumor tissue samples are analyzed for hepatoblastoma and other liver tumor biomarkers by microRNA array profiling and exome sequencing. Results are then compared with patients' clinical data. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Young patients with liver cancer
Key inclusion criteria (6 listed)
- Diagnosis of hepatoblastoma or other liver cancer including the following subtypes:
- Participated on the Children's Oncology Group (COG) clinical trials
- Available data and tumor samples
Key exclusion criteria (0 listed)
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 | Correlative (tissue analysis) |
| gene expression analysis | Genetic | Correlative (tissue analysis) |
| microarray analysisAlso: gene expression profiling | Genetic | Correlative (tissue analysis) |
| nucleic acid sequencingAlso: Gene Sequencing, Molecular Biology, Nucleic Acid Sequencing | Genetic | Correlative (tissue analysis) |
| diagnostic laboratory biomarker analysis | Other | Correlative (tissue analysis) |
Primary outcome
Biomarkers associated with hepatoblastoma subtypes and cancer stages
Time frame: Baseline
2 secondary outcomes
Genes involved in embryonic development and/or stem cell signaling pathways for which preliminary data suggests involvement in the pathogenesis of hepatoblastoma
Time frame: Baseline
Exome sequencing
Time frame: Baseline
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.
Gail Tomlinson, MD principal investigator
Children's Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Hepatoblastoma and Stage I Childhood Liver Cancer, run by Children's Oncology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Biomarkers associated with hepatoblastoma subtypes and cancer stages (time frame: Baseline). 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.