Hepatocellular CarcinomaNCT02908048
Extracellular RNA Markers of Liver Disease and Cancer
An observational study of Hepatocellular Carcinoma and Biliary Tract Cancer, run by Mayo Clinic at 4 sites in United States.
Trial summary
The study will examine and evaluate the use of extracellular RNA in blood as markers for the diagnosis of liver disease or cancer, and as markers for prediction of response to treatment or recurrence of cancer after surgery Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma, Biliary Tract Cancer, Cirrhosis
- What is being tested?
- Blood samples
- How many people
- 1,865 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2014to 2 Apr 2024
- How long will I take part?
- 5 Years
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing evaluation at Mayo Clinic Florida Liver Transplant, Surgery, Oncology or Radiology clinics who have hepatocellular carcinoma (HCC) or biliary tract cancers, cirrhosis without HCC, or chronic liver disease without cirrhosis.
Who may be able to join
- Lab results from within the previous 90 days.
- Diagnosis of HCC or biliary tract cancer
- Diagnosis of cirrhosis based on histology, imaging, or ultrasound.
- Diagnosis of a chronic liver disease without cirrhosis.
Who cannot join
- Prior solid organ transplant.
- Previous cancer history with the last 5 years (excluding non-melanoma skin cancer), participation in a treatment trial for HCC
- Exclusion criteria for the cirrhosis and chronic liver disease groups:
- Prior solid organ transplant.
- Previous or current cancer history within the past 5 years (excluding non-melanoma skin cancer).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The University of Chicago Medical Center
Chicago, Illinois, 60637
Mayo Clinic Florida
Jacksonville, Florida, 32224
McGuire VA Medical Center
Richmond, Virginia, 23249
Mayo Clinic
Rochester, Minnesota, 55905
About this study
The study will examine and evaluate the use of extracellular RNA in blood as markers for the diagnosis of liver disease or cancer, and as markers for prediction of response to treatment or recurrence of cancer after surgery
Read the detailed description
The goal is to identify an extracellular RNA candidate for the detection and diagnosis of liver cancers such as hepatocellular cancer or biliary cancer, and chronic liver diseases. The use of selected exRNA biomarkers for diagnosis of hepatocellular cancer (HCC) or biliary tract cancers in patients with cirrhosis will be evaluated in a prospective case-control study. The study will create a registry of patients who have chronic liver disease, cirrhosis, liver and biliary tract cancers. A risk factor questionnaire will be administered to facilitate identification of risk factors for development of liver cancer. Patient information will be obtained from the medical record, and include demographics, medical history, liver disease, smoking and alcohol history, etiology, family history, and clinical laboratory data.
- Being tested
- Blood samples
- Keywords
- liver cancer, cholangiocarcinoma (CCA), cirrhosis, hepatitis, bile duct cancer, hepatocellular carcinoma (HCC), hepatobiliary carcinoma, hepatoma, liver mass
- Medical subject headings
- Carcinoma, Hepatocellular, Biliary Tract Neoplasms, Fibrosis, Liver Diseases, Liver Neoplasms, Cholangiocarcinoma, Hepatitis, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Blood samples collected at varying intervals over a two to three year period.
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular Carcinoma | Blood samples will be collected at entry into the study and at varying intervals over a two to three year period. Receives: Other: Blood samples | |
| Biliary Tract Cancer | Blood samples will be collected at entry into the system and at varying intervals over a two to three year period. Receives: Other: Blood samples | |
| Cirrhosis | Blood samples will be collected during regular intervals over a three year period. Receives: Other: Blood samples | |
| Chronic Liver Disease without Cirrhosis | A single blood sample will be collected at entry into the study Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of liver cancer based on tumor markers and imaging studies.
The exRNA biomarker levels in the HCC and biliary tract cancer groups will be evaluated and compared to the exRNA biomarker levels present in the other groups, cirrhosis and chronic liver disease. Statistical analysis will be used to evaluate the sensitivity and specificity of these markers for the diagnosis of cancers based on findings of liver mass, imaging characteristics, size, and extent of viable tumor on imaging, or on elevated levels of tumor markers such as alpha-fetoprotein.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startJul 2014
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Why it stopped: Ran out of funds
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 Mayo ClinicThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,865 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Tushar Patel, Mayo Clinic
- Investigators
- Tushar Patel, MBChB, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908048
- Sponsor's protocol ID
- 14-004560
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2016
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracellular RNA Markers of Liver Disease and Cancer
- ClinicalTrials.gov ID
- NCT02908048
- Acronym / sponsor ID
- 14-004560
- Keywords
- liver cancer, cholangiocarcinoma (CCA), cirrhosis, hepatitis, bile duct cancer, hepatocellular carcinoma (HCC), hepatobiliary carcinoma, hepatoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Ran out of funds
- Enrolment
- 1,865 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- Jul 2014
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 20 Sep 2016 (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 study will examine and evaluate the use of extracellular RNA in blood as markers for the diagnosis of liver disease or cancer, and as markers for prediction of response to treatment or recurrence of cancer after surgery
Detailed description
The goal is to identify an extracellular RNA candidate for the detection and diagnosis of liver cancers such as hepatocellular cancer or biliary cancer, and chronic liver diseases. The use of selected exRNA biomarkers for diagnosis of hepatocellular cancer (HCC) or biliary tract cancers in patients with cirrhosis will be evaluated in a prospective case-control study. The study will create a registry of patients who have chronic liver disease, cirrhosis, liver and biliary tract cancers. A risk factor questionnaire will be administered to facilitate identification of risk factors for development of liver cancer. Patient information will be obtained from the medical record, and include demographics, medical history, liver disease, smoking and alcohol history, etiology, family history, and clinical laboratory data.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular Carcinoma | – | Other: Blood samplesBlood samples will be collected at entry into the study and at varying intervals over a two to three year period. |
| Biliary Tract Cancer | – | Other: Blood samplesBlood samples will be collected at entry into the system and at varying intervals over a two to three year period. |
| Cirrhosis | – | Other: Blood samplesBlood samples will be collected during regular intervals over a three year period. |
| Chronic Liver Disease without Cirrhosis | – | Other: Blood samplesA single blood sample will be collected at entry into the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing evaluation at Mayo Clinic Florida Liver Transplant, Surgery, Oncology or Radiology clinics who have hepatocellular carcinoma (HCC) or biliary tract cancers, cirrhosis without HCC, or chronic liver disease without cirrhosis.
Key inclusion criteria (4 listed)
- Lab results from within the previous 90 days.
- Diagnosis of HCC or biliary tract cancer
- Diagnosis of cirrhosis based on histology, imaging, or ultrasound.
- Diagnosis of a chronic liver disease without cirrhosis.
Key exclusion criteria (5 listed)
- Prior solid organ transplant.
- Previous cancer history with the last 5 years (excluding non-melanoma skin cancer), participation in a treatment trial for HCC
- Prior solid organ transplant.
- Previous or current cancer history within the past 5 years (excluding non-melanoma skin cancer).
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 |
|---|---|---|
| Blood samplesBlood samples collected at varying intervals over a two to three year period. | Other | Biliary Tract Cancer, Chronic Liver Disease without Cirrhosis, Cirrhosis, Hepatocellular Carcinoma |
Primary outcome
Diagnosis of liver cancer based on tumor markers and imaging studies.
Time frame: Five years
The exRNA biomarker levels in the HCC and biliary tract cancer groups will be evaluated and compared to the exRNA biomarker levels present in the other groups, cirrhosis and chronic liver disease. Statistical analysis will be used to evaluate the sensitivity and specificity of these markers for the diagnosis of cancers based on findings of liver mass, imaging characteristics, size, and extent of viable tumor on imaging, or on elevated levels of tumor markers such as alpha-fetoprotein.
Results and safety
The study was stopped early (reason given: Ran out of funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tushar Patel, MBChB principal investigator
Mayo Clinic
4 sites 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 and Biliary Tract Cancer, run by Mayo Clinic at 4 sites 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 4 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: stopped early, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early (reason given: Ran out of funds). Results are not available in the source record.
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?
Diagnosis of liver cancer based on tumor markers and imaging studies. (time frame: Five years). 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 5 May 2026.