CirrhosisNCT02258048
The Use of Transient Elastography to Predict Clinical Decompensation in Patients With Early Cirrhosis
An observational study of Cirrhosis, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a prospective study designed to examine the role of transient elastography as a predictor of clinical decompensation in patients with early cirrhosis. The study objective is to determine if changes in measurements of liver stiffness with transient elastography can identify patients that will have a more rapid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Ambulatory patients with histologic or radiographic evidence of cirrhosis
Who may be able to join
- Ambulatory patients with histologic or radiographic evidence of cirrhosis will be screened for participation in the study.
- Able to provide informed consent
- MELD score <10
- No history of ascites, variceal bleeding, hepatorenal syndrome, overt hepatic encephalopathy.
Who cannot join
- History of variceal bleeding, ascites, hepatorenal syndrome, or overt hepatic encephalopathy
- Inability to provide informed consent
- Body mass index (BMI)>35
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
This is a prospective study designed to examine the role of transient elastography as a predictor of clinical decompensation in patients with early cirrhosis. The study objective is to determine if changes in measurements of liver stiffness with transient elastography can identify patients that will have a more rapid progression of cirrhosis and the development of clinical decompensation. The target population is patients with early stage, well-compensated cirrhosis.
Participants of this study will be asked to complete the following procedures: read and sign the informed consent, medical records review (complete medical history, physical examination, laboratory evaluation, endoscopic findings, radiographic findings), undergo transient elastography to measure liver stiffness every three months until the development of clinical decompensation (ascites, variceal bleeding, hepatorenal syndrome, overt hepatic encephalopathy) for up to 2 years.
Read the detailed description
This is a prospective study designed to examine the role of transient elastography as a predictor of clinical decompensation in patients with early cirrhosis. The study objective is to determine if changes in measurements of liver stiffness with transient elastography can identify patients that will have a more rapid progression of cirrhosis and the development of clinical decompensation. The target population is patients with early stage, well-compensated cirrhosis.
This study will attempt to determine if serial measurements of liver stiffness with transient elastography in patients with early cirrhosis can identify patients at risk of morbidity or mortality associated with hepatic decompensation.
For the Screening Visit, the following procedures will be performed:
- Patient will read and sign informed consent. Subjects will be given sufficient time to consider, ask questions, and sign the consent forms.
- Patient will be assigned a subject number
- Patient will be asked to provide demographic information
- Patient will be asked to provide a complete medical history and laboratory evaluation
- Physical examination including blood pressure, heart rate, height, and weight.
- The following assessments will also be performed:
- Calculation of modified Child Pugh Score: Using the following biochemical variables: Serum Albumin, Total Bilirubin, Serum Creatinine, and INR.
- MELD Score: Based on a continuous function of Bilirubin, INR, and Creatinine, which uses a continuous variable ranging from 6-40.
- 30cc of blood will be obtained, and serum frozen at -80C (freezer located in Dr. Sigal's office) for up to 5 years. The blood will only be accessible to Dr. Sigal and his research team. This blood may be analysed for known markers of liver disease, markers that may be discovered in the future, and/or to identify new markers of liver disease.
For the Follow-Up Visits the following procedures will be performed every 3 months for up to 2 years:
- An interim medical history will be obtained, with particular attention to the development of clinical decompensation (ascites, variceal bleeding hepatorenal syndrome, overt hepatic encephalopathy).
- Physical examination.
- Measurement of liver stiffness using hepatic elastography.
- 30cc of blood will be obtained, and serum frozen for future analyses as above.
- Conditions
- Cirrhosis
- Keywords
- Cirrhosis
- Medical subject headings
- Fibrosis
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 |
|---|---|---|
| Patients with cirrhosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Stiffness
Liver stiffness will be measured using hepatic elastography.
Measured: 2 years
Secondary outcomes (1)
Evidence of Portal Hypertension
Presence of significant portal hypertension will be determined by the presence of ascites or thrombocytopenia.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Samuel Sigal no longer with NYU
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Sigal, M.D., Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258048
- Sponsor's protocol ID
- 10-02236
- Status last verified
- Mar 2016
- First submitted
- 2 Oct 2014
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Transient Elastography to Predict Clinical Decompensation in Patients With Early Cirrhosis
- ClinicalTrials.gov ID
- NCT02258048
- Acronym / sponsor ID
- 10-02236
- Conditions
- Cirrhosis
- Keywords
- Cirrhosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Samuel Sigal no longer with NYU
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Oct 2014 (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.
This is a prospective study designed to examine the role of transient elastography as a predictor of clinical decompensation in patients with early cirrhosis. The study objective is to determine if changes in measurements of liver stiffness with transient elastography can identify patients that will have a more rapid progression of cirrhosis and the development of clinical decompensation. The target population is patients with early stage, well-compensated cirrhosis.
Participants of this study will be asked to complete the following procedures: read and sign the informed consent, medical records review (complete medical history, physical examination, laboratory evaluation, endoscopic findings, radiographic findings), undergo transient elastography to measure liver stiffness every three months until the development of clinical decompensation (ascites, variceal bleeding, hepatorenal syndrome, overt hepatic encephalopathy) for up to 2 years.
Detailed description
This is a prospective study designed to examine the role of transient elastography as a predictor of clinical decompensation in patients with early cirrhosis. The study objective is to determine if changes in measurements of liver stiffness with transient elastography can identify patients that will have a more rapid progression of cirrhosis and the development of clinical decompensation. The target population is patients with early stage, well-compensated cirrhosis.
This study will attempt to determine if serial measurements of liver stiffness with transient elastography in patients with early cirrhosis can identify patients at risk of morbidity or mortality associated with hepatic decompensation.
For the Screening Visit, the following procedures will be performed:
- Patient will read and sign informed consent. Subjects will be given sufficient time to consider, ask questions, and sign the consent forms.
- Patient will be assigned a subject number
- Patient will be asked to provide demographic information
- Patient will be asked to provide a complete medical history and laboratory evaluation
- Physical examination including blood pressure, heart rate, height, and weight.
- The following assessments will also be performed:
- Calculation of modified Child Pugh Score: Using the following biochemical variables: Serum Albumin, Total Bilirubin, Serum Creatinine, and INR.
- MELD Score: Based on a continuous function of Bilirubin, INR, and Creatinine, which uses a continuous variable ranging from 6-40.
- 30cc of blood will be obtained, and serum frozen at -80C (freezer located in Dr. Sigal's office) for up to 5 years. The blood will only be accessible to Dr. Sigal and his research team. This blood may be analysed for known markers of liver disease, markers that may be discovered in the future, and/or to identify new markers of liver disease.
For the Follow-Up Visits the following procedures will be performed every 3 months for up to 2 years:
- An interim medical history will be obtained, with particular attention to the development of clinical decompensation (ascites, variceal bleeding hepatorenal syndrome, overt hepatic encephalopathy).
- Physical examination.
- Measurement of liver stiffness using hepatic elastography.
- 30cc of blood will be obtained, and serum frozen for future analyses as above.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cirrhosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulatory patients with histologic or radiographic evidence of cirrhosis
Key inclusion criteria (4 listed)
- Ambulatory patients with histologic or radiographic evidence of cirrhosis will be screened for participation in the study.
- Able to provide informed consent
- MELD score <10
- No history of ascites, variceal bleeding, hepatorenal syndrome, overt hepatic encephalopathy.
Key exclusion criteria (3 listed)
- History of variceal bleeding, ascites, hepatorenal syndrome, or overt hepatic encephalopathy
- Inability to provide informed consent
- Body mass index (BMI)>35
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
Liver Stiffness
Time frame: 2 years
Liver stiffness will be measured using hepatic elastography.
1 secondary outcome
Evidence of Portal Hypertension
Time frame: 2 years
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 10 Mar 2016.
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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.
Samuel Sigal, M.D. principal investigator
NYU Langone Medical Center
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 Cirrhosis, run by NYU Langone Health 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 3 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 10 Mar 2016. 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 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?
Liver Stiffness (time frame: 2 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 10 Mar 2016.