Liver CancerNCT00899002
Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer
An observational study of Liver Cancer, run by Vanderbilt-Ingram Cancer Center.
Trial summary
RATIONALE: Studying samples of 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 laboratory study is looking at biomarkers in stored tumor samples from younger patients with liver cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cancer
- What is being tested?
- comparative genomic hybridization, molecular genetic technique and mutation analysis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to May 2009
- 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: Sample collection: 20 cases of fibrolamellar carcinoma and 20 hepatocellular carcinomas.
Who may be able to join
- DISEASE CHARACTERISTICS:
- Diagnosis of fibrolamellar carcinoma or hepatocellular carcinoma in a non-cirrhotic liver
- Archived tumor specimens available for analysis from Vanderbilt University or Mayo Clinic
Who cannot join
- Not specified
- PATIENT CHARACTERISTICS:
- Not specified
- PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Molecular Analysis of Liver Cancer
RATIONALE: Studying samples of 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 laboratory study is looking at biomarkers in stored tumor samples from younger patients with liver cancer.
Read the detailed description
OBJECTIVES:
- To characterize, at a molecular level, archived samples of tissue from young patients with fibrolamellar carcinoma and hepatocellular carcinoma in non-cirrhotic livers matched for age and sex.
- To perform genomic analysis on these tissue samples using array comparative genomic hybridization.
- To perform targeted gene mutation analysis on these samples by PCR.
- To perform proteomic profiling on fixed tissues in these samples by various proteomic methods, including IHC and mass spectrometry.
- To look for association between molecular aberrations and clinicopathologic features in these samples.
OUTLINE: Archived tissue samples are collected from the pathology department at Vanderbilt University Medical Center and from the Mayo Clinic in Rochester, Minnesota. Tissue samples are analyzed by genomic analysis using array comparative genomic hybridization, target gene mutation analysis by PCR, and proteomic profiling on fixed tissues using various proteomic methods, including IHC and mass spectrometry. Samples are also examined for association between molecular aberrations and clinicopathologic features found in each disease.
Clinical patient data (i.e., age, sex, race, date of diagnosis, risk factors, histology, surgical staging, follow-ups, date of death, and adjuvant therapy) are also collected.
- Conditions
- Liver Cancer
- Being tested
- comparative genomic hybridization, molecular genetic technique, mutation analysis, polymerase chain reaction, proteomic profiling
- Keywords
- childhood hepatocellular carcinoma, childhood liver cancer, adult primary liver cancer, adult primary hepatocellular carcinoma
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparative genomic hybridizationGenetic
Also called None specified
molecular genetic techniqueGenetic
Also called none noted
mutation analysisGenetic
Also called none noted
polymerase chain reactionGenetic
Also called none specified
Not noted
proteomic profilingGenetic
Also called none noted
immunohistochemistry staining methodOther
Also called none specified
not noted
laboratory biomarker analysisOther
Also called none specified
not noted
mass spectrometryOther
Also called none specified
not noted
medical chart reviewOther
Also called none specified
not noted
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of proteomic profiles and molecular pathways involved in tumor progression
Genomic analysis, targeted gene mutation analysis, immunohistochemistry, and mass spectrometry will be employed to identify proteomic profiles and specific molecular pathways involved in tumor progression of fibrolamellar carcinoma and hepatocellular carcinoma
Measured: After collection of tissue samples
Secondary outcomes (1)
Association between fibrolamellar carcinoma and hepatocellular carcinoma in terms of molecular aberrations and clinicopathologic features
Compare and contrast fibrolamellar carcinoma with hepatocellular carcinoma in terms of the molecular differences, tissue pathologies, and medical histories.
Measured: After molecular analysis of tissue and after collection of clinicopathologic data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJul 2007
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Laura Goff, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899002
- Sponsor's protocol ID
- VICC GI 0611
- Other IDs
- VU-VICC-GI-0611, VU-VICC-060479
- Status last verified
- Apr 2013
- First submitted
- 9 May 2009
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analysis of Liver Cancer
- ClinicalTrials.gov ID
- NCT00899002
- Acronym / sponsor ID
- VICC GI 0611
- Conditions
- Liver Cancer
- Keywords
- childhood hepatocellular carcinoma, childhood liver cancer, adult primary liver cancer, adult primary hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 12 May 2009 (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 learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at biomarkers in stored tumor samples from younger patients with liver cancer.
Detailed description
OBJECTIVES:
- To characterize, at a molecular level, archived samples of tissue from young patients with fibrolamellar carcinoma and hepatocellular carcinoma in non-cirrhotic livers matched for age and sex.
- To perform genomic analysis on these tissue samples using array comparative genomic hybridization.
- To perform targeted gene mutation analysis on these samples by PCR.
- To perform proteomic profiling on fixed tissues in these samples by various proteomic methods, including IHC and mass spectrometry.
- To look for association between molecular aberrations and clinicopathologic features in these samples.
OUTLINE: Archived tissue samples are collected from the pathology department at Vanderbilt University Medical Center and from the Mayo Clinic in Rochester, Minnesota. Tissue samples are analyzed by genomic analysis using array comparative genomic hybridization, target gene mutation analysis by PCR, and proteomic profiling on fixed tissues using various proteomic methods, including IHC and mass spectrometry. Samples are also examined for association between molecular aberrations and clinicopathologic features found in each disease.
Clinical patient data (i.e., age, sex, race, date of diagnosis, risk factors, histology, surgical staging, follow-ups, date of death, and adjuvant therapy) are also collected.
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
- Sample collection: 20 cases of fibrolamellar carcinoma and 20 hepatocellular carcinomas.
Key inclusion criteria (3 listed)
- Diagnosis of fibrolamellar carcinoma or hepatocellular carcinoma in a non-cirrhotic liver
- Archived tumor specimens available for analysis from Vanderbilt University or Mayo Clinic
Key exclusion criteria (5 listed)
- Not specified
- Not specified
- Not specified
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 |
|---|---|---|
| comparative genomic hybridizationAlso: None specified | Genetic | – |
| molecular genetic techniqueAlso: none noted | Genetic | – |
| mutation analysisAlso: none noted | Genetic | – |
| polymerase chain reactionAlso: none specifiedNot noted | Genetic | – |
| proteomic profilingAlso: none noted | Genetic | – |
| immunohistochemistry staining methodAlso: none specifiednot noted | Other | – |
| laboratory biomarker analysisAlso: none specifiednot noted | Other | – |
| mass spectrometryAlso: none specifiednot noted | Other | – |
| medical chart reviewAlso: none specifiednot noted | Other | – |
Primary outcome
Identification of proteomic profiles and molecular pathways involved in tumor progression
Time frame: After collection of tissue samples
Genomic analysis, targeted gene mutation analysis, immunohistochemistry, and mass spectrometry will be employed to identify proteomic profiles and specific molecular pathways involved in tumor progression of fibrolamellar carcinoma and hepatocellular carcinoma
1 secondary outcome
Association between fibrolamellar carcinoma and hepatocellular carcinoma in terms of molecular aberrations and clinicopathologic features
Time frame: After molecular analysis of tissue and after collection of clinicopathologic data
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
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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.
Laura Goff, MD study chair
Vanderbilt-Ingram Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Vanderbilt-Ingram Cancer Center.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 10 Apr 2013. 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 was withdrawn before enrolling participants, so there are no results.
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 proteomic profiles and molecular pathways involved in tumor progression (time frame: After collection of tissue samples). 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 10 Apr 2013.