Hepatocellular CarcinomaNCT02412579
Genetic Profiling of Liver Cancer in Patients Undergoing Liver Transplantation
An observational study of Hepatocellular Carcinoma, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether genetic markers unique to liver cancer are present and to assess usefulness as a diagnostic tool. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 17 Mar 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatocellular Carcinoma Clinic Pre-Liver Transplant Clinic
Who may be able to join
- Patients with the diagnosis of HCC who are on the wait list for liver transplantation
- Patients with the diagnosis of HCC who have been admitted to hospital, scheduled to undergo liver transplantation within the following 24 hours.
- Age Range: 18 to 75 years old
Who cannot join
- Patients with metastatic HCC and patients with the diagnosis of HCC who are not on the wait list for liver transplantation.
- Patients older than 75 years old and younger than 18 years old.
- Patients who are unable to consent.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: Circulating MicroRNA Isoforms as Biomarkers in Hepatocellular Carcinoma and Associated Liver Transplantation
The purpose of this study is to determine whether genetic markers unique to liver cancer are present and to assess usefulness as a diagnostic tool.
Read the detailed description
Hepatocellular carcinoma (HCC) is the most common form of liver cancer and a growing trend worldwide. Decision-making regarding treatment for patients is limited by the lack of clinically actionable biomarkers. This is pronounced in the case for determining and monitoring liver transplant recipients. In an effort to improve diagnosis, the use of circulating serum-based microRNA isoforms (isomiRs) can serve as non-invasive, screening biomarkers in HCC patients pre- and post-transplantation of the liver.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- None - Standard of Care
- Keywords
- HCC, Liver Cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - Standard of CareOther
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular Carcinoma with Cirrhosis | Subjects with hepatocellular carcinoma and cirrhosis. Receives: Other: None - Standard of Care | |
| Cirrhosis without Hepatocellular Carcinoma | Subjects with only cirrhosis. Receives: Other: None - Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using next-generation sequencing methods to detect isomiRs across different HCC cohorts at all stages undergoing liver transplantation.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startMar 2015
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
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 Baylor Research InstituteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Kim, M.D., Principal investigator, Annette C. & Harold C. Simmons Transplant Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412579
- Sponsor's protocol ID
- 014-121
- Status last verified
- Jul 2022
- First submitted
- 6 Apr 2015
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating MicroRNA Isoforms as Biomarkers in Hepatocellular Carcinoma and Associated Liver Transplantation
- ClinicalTrials.gov ID
- NCT02412579
- Acronym / sponsor ID
- 014-121
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, Liver Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 9 Apr 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 determine whether genetic markers unique to liver cancer are present and to assess usefulness as a diagnostic tool.
Detailed description
Hepatocellular carcinoma (HCC) is the most common form of liver cancer and a growing trend worldwide. Decision-making regarding treatment for patients is limited by the lack of clinically actionable biomarkers. This is pronounced in the case for determining and monitoring liver transplant recipients. In an effort to improve diagnosis, the use of circulating serum-based microRNA isoforms (isomiRs) can serve as non-invasive, screening biomarkers in HCC patients pre- and post-transplantation of the liver.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular Carcinoma with Cirrhosis | – | Other: None - Standard of CareSubjects with hepatocellular carcinoma and cirrhosis. |
| Cirrhosis without Hepatocellular Carcinoma | – | Other: None - Standard of CareSubjects with only cirrhosis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatocellular Carcinoma Clinic Pre-Liver Transplant Clinic
Key inclusion criteria (3 listed)
- Patients with the diagnosis of HCC who are on the wait list for liver transplantation
- Patients with the diagnosis of HCC who have been admitted to hospital, scheduled to undergo liver transplantation within the following 24 hours.
- Age Range: 18 to 75 years old
Key exclusion criteria (4 listed)
- Patients with metastatic HCC and patients with the diagnosis of HCC who are not on the wait list for liver transplantation.
- Patients older than 75 years old and younger than 18 years old.
- Patients who are unable to consent.
- Pregnant patients.
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 |
|---|---|---|
| None - Standard of Care | Other | Cirrhosis without Hepatocellular Carcinoma, Hepatocellular Carcinoma with Cirrhosis |
Primary outcome
Using next-generation sequencing methods to detect isomiRs across different HCC cohorts at all stages undergoing liver transplantation.
Time frame: One year
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 20 Jul 2022.
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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.
Peter Kim, M.D. principal investigator
Annette C. & Harold C. Simmons Transplant Institute
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 Baylor Research Institute 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 3 inclusion and 4 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 20 Jul 2022. 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?
Using next-generation sequencing methods to detect isomiRs across different HCC cohorts at all stages undergoing liver transplantation. (time frame: One year). 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 20 Jul 2022.