Hepatocellular CarcinomaNCT01963949
Prospective, Observational Study of Biomarkers in Liver Cancer - Identification of Actionable Events
An observational study of Hepatocellular Carcinoma, run by University of Texas Southwestern Medical Center.
Trial summary
To collect tumor tissue from patients with liver masses suspicious for primary liver cancer. The research biopsy will be used to identify biomarkers in future studies. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Nov 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 500 patients with a liver mass suspicious for HCC
Who may be able to join
- Liver mass suspicious for primary liver cancer with a diagnostic liver biopsy planned as a part of clinical care
- Age ≥ 18 years.
- ECOG performance status 0-2
- Adequate organ and marrow function as defined below:
- INR ≤ 1.5 platelets ≥ 70,000/mcl
- Ability to understand and the willingness to sign a written informed consent
- Target liver mass not subcapsular in nature as determined by the participating biopsy team
- Child Pugh Turcotte score A or B
Who cannot join
- Previous treatment for HCC
- Any contraindication for clinical-care liver biopsy, including anti-coagulation therapy that cannot be discontinued prior to biopsy or large volume ascites
About this study
To collect tumor tissue from patients with liver masses suspicious for primary liver cancer. The research biopsy will be used to identify biomarkers in future studies.
Read the detailed description
In this study patients are referred to the Department of Radiology for an image-guided (either CT or ultrasound) core needle biopsy of a liver mass suspicious for primary liver cancer as a part their clinical care. A written informed consent will be obtained for the clinical biopsy per standard protocol. Additional core biopsy of the liver mass will be performed for research purposes at the time of the clinical care biopsy. The additional research biopsy is not mandatory and is subject to a separate written informed consent, which will be obtained prior to the clinical biopsy.
- Conditions
- 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 |
|---|---|---|
| Primary Liver Cancer | Patients that have liver masses suspicious for primary liver cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy of Liver Masses
To obtain tissue from biopsy of liver masses suspicious for primary liver cancer for use in future biomarker studies.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2018 (estimated)
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 University of Texas Southwestern Medical CenterThe 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
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Yopp, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963949
- Sponsor's protocol ID
- SCCC
- Status last verified
- May 2014
- First submitted
- 11 Oct 2013
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study of Biomarkers in Liver Cancer - Identification of Actionable Events
- ClinicalTrials.gov ID
- NCT01963949
- Acronym / sponsor ID
- SCCC
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2018 (estimated)
- First posted
- 17 Oct 2013 (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.
To collect tumor tissue from patients with liver masses suspicious for primary liver cancer. The research biopsy will be used to identify biomarkers in future studies.
Detailed description
In this study patients are referred to the Department of Radiology for an image-guided (either CT or ultrasound) core needle biopsy of a liver mass suspicious for primary liver cancer as a part their clinical care. A written informed consent will be obtained for the clinical biopsy per standard protocol. Additional core biopsy of the liver mass will be performed for research purposes at the time of the clinical care biopsy. The additional research biopsy is not mandatory and is subject to a separate written informed consent, which will be obtained prior to the clinical biopsy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Liver Cancer | – | –Patients that have liver masses suspicious for primary liver cancer. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 500 patients with a liver mass suspicious for HCC
Key inclusion criteria (8 listed)
- Liver mass suspicious for primary liver cancer with a diagnostic liver biopsy planned as a part of clinical care
- Age ≥ 18 years.
- ECOG performance status 0-2
- Adequate organ and marrow function as defined below:
- INR ≤ 1.5 platelets ≥ 70,000/mcl
Key exclusion criteria (2 listed)
- Previous treatment for HCC
- Any contraindication for clinical-care liver biopsy, including anti-coagulation therapy that cannot be discontinued prior to biopsy or large volume ascites
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
Biopsy of Liver Masses
Time frame: 5 years
To obtain tissue from biopsy of liver masses suspicious for primary liver cancer for use in future biomarker studies.
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 19 May 2014.
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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.
Adam Yopp, MD principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by University of Texas Southwestern Medical 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 8 inclusion and 2 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 19 May 2014. 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?
Biopsy of Liver Masses (time frame: 5 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 19 May 2014.