Hepatocellular CarcinomaNCT04720430
Blood Sample Collection for Experimental Blood Test to Track Liver Cancer
An observational study of Hepatocellular Carcinoma, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This study investigates if an experimental blood test can help predict how well cancer will remain under control with treatment. Ther experimental blood test involves measuring mircoRNAs. MicroRNAs are small molecules which help regulate how genes are expressed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2019to 9 Nov 2023
- 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
- Adult, Older adult
Study population: Patientss with hepatocellular carcinoma felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy
Who may be able to join
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Definite diagnosis of hepatocellular carcinoma established (by standard radiographic or histologic criteria)
- Felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy
Who cannot join
- Either active or recent solid organ cancer other than hepatocellur carcinoma (HCC) within the last 5 years, unless determined by transplant hepatology team not to represent contra-indication to liver transplantation
- Contra-indication to LRT (as assessed by interventional radiologist, for example severe thrombocytopenia, severe vascular disease precluding access, etc)
- History of prior liver transplantation
- Active or prior systemic therapy for HCC
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Circulating MicroRNA Levels as a Predictor of Successful Bridging or Down-Staging Loco-Regional Therapy (LRT) to Liver Transplantation for Patients With Hepatocellular Carcinoma (HCC)
This study investigates if an experimental blood test can help predict how well cancer will remain under control with treatment. Ther experimental blood test involves measuring mircoRNAs. MicroRNAs are small molecules which help regulate how genes are expressed. This information may help researchers guide treatment for other patients in the future.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Clinical Status - Liver Transplant
Undergoing liver transplant
Measured: At study completion, up to 12 months
Patient Clinical Status - Death
Will assess the following: death
Measured: At study completion, up to 12 months
Patient Clinical Status - Candidacy
No longer candidate for transplantation for reasons other than tumor progression
Measured: At study completion, up to 12 months
Patient Clinical Status
No longer candidate for transplantation due to tumor progression despite loco-regional therapy efforts
Measured: At study completion, up to 12 months
Incidence of "Wait List Drop Off"
Will be estimated and presented with a Clopper-Pearson exact binomial confidence interval
Measured: At study completion, up to 12 months
Secondary outcomes (2)
Time to "Wait List Drop Off"
Cox proportinal hazards modeling will be used to investigate the associations of each micro ribonucleic acid (miRNO) with time to "wait list drop off"
Measured: Up to 12 months
Clinical Status of the subset of patients successfully reaching liver transplant
Logistic regression modeling will be used to investigate the correlation of each miRNA with clincial status (alive without recurrence vs. recurrence or death) within one year of transplant will be cinducted in the subset of those undergoing transplant. The p-values will be adjusted for false discovery rate inflation by the methods of Benjamni \& Hochberg (1995) for both secondary analyses, respectively
Measured: At 1 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start3 Dec 2019
- Primary completion15 Feb 2023
- Study completion9 Nov 2023
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 Thomas Jefferson 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
- Cohort
- Time perspective
- Other
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720430
- Sponsor's protocol ID
- 19D.737
- Other IDs
- JT 13572
- Status last verified
- Apr 2025
- First submitted
- 7 Dec 2020
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating MicroRNA Levels as a Predictor of Successful Bridging or Down-Staging Loco-Regional Therapy (LRT) to Liver Transplantation for Patients With Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT04720430
- Acronym / sponsor ID
- 19D.737
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- 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 study investigates if an experimental blood test can help predict how well cancer will remain under control with treatment. Ther experimental blood test involves measuring mircoRNAs. MicroRNAs are small molecules which help regulate how genes are expressed. This information may help researchers guide treatment for other patients in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patientss with hepatocellular carcinoma felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy
Key inclusion criteria (4 listed)
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Definite diagnosis of hepatocellular carcinoma established (by standard radiographic or histologic criteria)
- Felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy
Key exclusion criteria (4 listed)
- Either active or recent solid organ cancer other than hepatocellur carcinoma (HCC) within the last 5 years, unless determined by transplant hepatology team not to represent contra-indication to liver transplantation
- Contra-indication to LRT (as assessed by interventional radiologist, for example severe thrombocytopenia, severe vascular disease precluding access, etc)
- History of prior liver transplantation
- Active or prior systemic therapy for HCC
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
Patient Clinical Status - Liver Transplant
Time frame: At study completion, up to 12 months
Undergoing liver transplant
Patient Clinical Status - Death
Time frame: At study completion, up to 12 months
Will assess the following: death
Patient Clinical Status - Candidacy
Time frame: At study completion, up to 12 months
No longer candidate for transplantation for reasons other than tumor progression
Patient Clinical Status
Time frame: At study completion, up to 12 months
No longer candidate for transplantation due to tumor progression despite loco-regional therapy efforts
Incidence of "Wait List Drop Off"
Time frame: At study completion, up to 12 months
Will be estimated and presented with a Clopper-Pearson exact binomial confidence interval
2 secondary outcomes
Time to "Wait List Drop Off"
Time frame: Up to 12 months
Clinical Status of the subset of patients successfully reaching liver transplant
Time frame: At 1 year after transplantation
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 29 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thomas Jefferson 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 4 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 29 Apr 2025. 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?
Patient Clinical Status - Liver Transplant (time frame: At study completion, up to 12 months). The study lists 5 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 29 Apr 2025.