Hepatocellular CarcinomaNCT02358070
Epidemiologic Study of Hepatocellular Carcinoma in the US
An observational study of Hepatocellular Carcinoma, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is: to investigate the risk factors of HCC among Americans with focus on lifestyle factors and energy balance. to identify single nucleotide polymorphisms (SNPs) and haplotypes that are associated with HCC risk through a genome-wide search. Read more about this study
- Who is it for?
- Ages 35 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 1 Sep 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 35 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with Hepatocellular Carcinoma in New Jersey and Connecticut as well as selected patients in New York, Hawaii and northern California. Healthy volunteers will comprise a random sample of New Jersey and Connecticut residents as controls.
Who may be able to join
- a diagnosis of primary liver cancer (excluding secondary tumors)
- a diagnosis of hepatocellular carcinoma if histology is available (excluding those diagnosed in intrahepatic bile duct, bile canals, biliary passages, canaliculi, gall duct and gallbladder)
- a diagnosis of hepatocellular carcinoma with or without microscopic evaluation (including those diagnosed with clinical evidence, lab tests and direct visualization or radiographic and other imaging evidence)
- a histology of primary hepatocellular carcinoma when the patients had a prior diagnosis of other forms of cancer (excluding those who had no histological diagnosis of hepatocellular carcinoma while having a prior history of other cancer;
- age at diagnosis between 35 and 84 years
- living in Connecticut, New Jersey, New York, or Hawaii for at least a year as regular residents.
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- age between 35 and 84 years
- living in New Jersey or Connecticut for at least a year as regular residents
- able to communicate well in English or Spanish
- having no medical conditions, such as mental disorders, that prevent them from providing adequately comprehensible information
- potential subjects with a previous history of cancer are eligible.
Who cannot join
- uncertain diagnoses or classification of malignancy, such as unknown origin
- a diagnosis of primary tumors in other organs, not in the liver
- unable to communicate well enough in English or Spanish
- having medical conditions, such as mental disorders, that prevent the subject from providing reasonably comprehensible information or from being able to give informed consent.
- diagnosed at age <35 years or >84 years
- temporary residents of New Jersey, Connecticut, New York, or Hawaii
Show all 10Show fewer
- age < 35 years or > 84 years
- temporary residents of New Jersey or Connecticut
- unable to speak English or Spanish
- cannot provide adequately comprehensible information
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Liver Transplant Clinic
Stanford, California, 94305
About this study
The purpose of this study is:
- to investigate the risk factors of HCC among Americans with focus on lifestyle factors and energy balance.
- to identify single nucleotide polymorphisms (SNPs) and haplotypes that are associated with HCC risk through a genome-wide search.
- to assess if genetic susceptibility differs by hepatitis virus infection or lifestyle factors, and to explore if there are interplays or effect modifications between genetic factors and viral infection or lifestyle factors.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCC group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifetime physical activity
Lifetime physical activity will be measured by collecting data on major types of physical activity separately and by determining frequency, intensity, and duration of each activity using a combined modification of Friedenreich's lifetime physical activity questionnaire and Kriska's past year physical activity questionnaires.
Measured: 20 years
Energy intake
A modified Food Frequency questionnaire based on one developed by Dr. Alan Kristal from the Fred Hutchinson Cancer Research Center (FHCRC) in Seattle will capture energy intake by differentiating low-fat food options from higher-fat counterparts.
Measured: 20 years
Lifestyle factors
Structured questionnaires will be used to elicit information on demographic, anthropometric, and socioeconomic factors, long-term use of medications, medical history, and family history of cancer, cigarette smoking and alcohol consumption, physical activity, and dietary habits. Additional information unrelated to liver cancer will be included in the questionnaire to help assess possible recall bias.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startApr 2015
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mindie Nguyen, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358070
- Sponsor's protocol ID
- HEP0049
- Status last verified
- Mar 2020
- First submitted
- 29 Jan 2015
- Last updated
- 24 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study of Hepatocellular Carcinoma in the US
- ClinicalTrials.gov ID
- NCT02358070
- Acronym / sponsor ID
- HEP0049
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 6 Feb 2015 (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.
The purpose of this study is:
- to investigate the risk factors of HCC among Americans with focus on lifestyle factors and energy balance.
- to identify single nucleotide polymorphisms (SNPs) and haplotypes that are associated with HCC risk through a genome-wide search.
- to assess if genetic susceptibility differs by hepatitis virus infection or lifestyle factors, and to explore if there are interplays or effect modifications between genetic factors and viral infection or lifestyle factors.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC group | – | – |
| control group | – | – |
Who may qualify
- Ages
- 35 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with Hepatocellular Carcinoma in New Jersey and Connecticut as well as selected patients in New York, Hawaii and northern California. Healthy volunteers will comprise a random sample of New Jersey and Connecticut residents as controls.
Key inclusion criteria (11 listed)
- a diagnosis of primary liver cancer (excluding secondary tumors)
- a diagnosis of hepatocellular carcinoma if histology is available (excluding those diagnosed in intrahepatic bile duct, bile canals, biliary passages, canaliculi, gall duct and gallbladder)
- a diagnosis of hepatocellular carcinoma with or without microscopic evaluation (including those diagnosed with clinical evidence, lab tests and direct visualization or radiographic and other imaging evidence)
- a histology of primary hepatocellular carcinoma when the patients had a prior diagnosis of other forms of cancer (excluding those who had no histological diagnosis of hepatocellular carcinoma while having a prior history of other cancer;
- age at diagnosis between 35 and 84 years
Key exclusion criteria (10 listed)
- uncertain diagnoses or classification of malignancy, such as unknown origin
- a diagnosis of primary tumors in other organs, not in the liver
- unable to communicate well enough in English or Spanish
- having medical conditions, such as mental disorders, that prevent the subject from providing reasonably comprehensible information or from being able to give informed consent.
- diagnosed at age <35 years or >84 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lifetime physical activity
Time frame: 20 years
Lifetime physical activity will be measured by collecting data on major types of physical activity separately and by determining frequency, intensity, and duration of each activity using a combined modification of Friedenreich's lifetime physical activity questionnaire and Kriska's past year physical activity questionnaires.
Energy intake
Time frame: 20 years
A modified Food Frequency questionnaire based on one developed by Dr. Alan Kristal from the Fred Hutchinson Cancer Research Center (FHCRC) in Seattle will capture energy intake by differentiating low-fat food options from higher-fat counterparts.
Lifestyle factors
Time frame: 20 years
Structured questionnaires will be used to elicit information on demographic, anthropometric, and socioeconomic factors, long-term use of medications, medical history, and family history of cancer, cigarette smoking and alcohol consumption, physical activity, and dietary habits. Additional information unrelated to liver cancer will be included in the questionnaire to help assess possible recall bias.
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 24 Mar 2020.
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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.
Mindie Nguyen, MD principal investigator
Stanford University
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 Hepatocellular Carcinoma, run by Stanford University 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 11 inclusion and 10 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 24 Mar 2020. 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?
Lifetime physical activity (time frame: 20 years). The study lists 3 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 24 Mar 2020.