Fatty LiverNASHNCT02860884
Using Infrared Spectroscopy for Diagnosis Severity of Nonalcoholic Fatty Liver Disease
An observational study of Fatty Liver and Non-alcoholic Fatty Liver Disease, run by Rennes University Hospital at 1 site in France.
Trial summary
The main objective of this study is to evaluate the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatty Liver, Non-alcoholic Fatty Liver Disease
- What is being tested?
- liver biopsy and infrared spectroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- Aug 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: Patients who have undergone a liver biopsy for simple fatty liver or NASH and for which a serum sample is serum bank
Who may be able to join
- Patients who have undergone a liver biopsy for simple fatty liver or NASH and for which a serum sample is serum bank
- Men or Women
- aged of 18 years or more
- After giving their consent to participate in research
Who cannot join
- Known Cancer
- Refusal of consent
- Inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to evaluate the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH
- Conditions
- Fatty Liver, Non-alcoholic Fatty Liver Disease
- Being tested
- liver biopsy, infrared spectroscopy
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver biopsyProcedure or surgery
infrared spectroscopyOther
| Study group | Role | What they receive |
|---|---|---|
| simple fatty liver | patients with fatty liver disease Receives: Procedure: liver biopsy; Other: infrared spectroscopy | |
| NASH | patients with nonalcoholic steatohepatitis Receives: Procedure: liver biopsy; Other: infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Evaluation of the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH with liver biopsy as a gold standard
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Retrospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860884
- Sponsor's protocol ID
- 35RC13_8989
- Acronym
- NASH
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 9 Aug 2016
- 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 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Infrared Spectroscopy for Diagnosis Severity of Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT02860884
- Acronym / sponsor ID
- NASH / 35RC13_8989
- Conditions
- Fatty Liver, Non-alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Aug 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 main objective of this study is to evaluate the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simple fatty liver | – | Procedure: liver biopsy, Other: infrared spectroscopypatients with fatty liver disease |
| NASH | – | Procedure: liver biopsy, Other: infrared spectroscopypatients with nonalcoholic steatohepatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone a liver biopsy for simple fatty liver or NASH and for which a serum sample is serum bank
Key inclusion criteria (4 listed)
- Patients who have undergone a liver biopsy for simple fatty liver or NASH and for which a serum sample is serum bank
- Men or Women
- aged of 18 years or more
- After giving their consent to participate in research
Key exclusion criteria (3 listed)
- Known Cancer
- Refusal of consent
- Inflammatory disease
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 |
|---|---|---|
| liver biopsy | Procedure or surgery | NASH, simple fatty liver |
| infrared spectroscopy | Other | NASH, simple fatty liver |
Primary outcome
Sensitivity
Time frame: through study completion, an average of 1 year
Evaluation of the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH with liver biopsy as a gold standard
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 9 Aug 2016.
- 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.
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 Fatty Liver and Non-alcoholic Fatty Liver Disease, run by Rennes University Hospital at 1 site in France.
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: finished, as of the sponsor's last update on 9 Aug 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 France. 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?
Sensitivity (time frame: through study completion, an average of 1 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 9 Aug 2016.