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CompletedNCT02860884NASHUpdated Aug 9, 2016

Using Infrared Spectroscopy for Diagnosis Severity of Nonalcoholic Fatty Liver Disease

An observational study in Fatty Liver and Non-alcoholic Fatty Liver Disease, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-09.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
136
Ages
18 Years and older
Sex
All
01

Study summary

The main objective of this study is to evaluate the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH

02

Conditions studied

  • Fatty Liver
  • Non-alcoholic Fatty Liver Disease
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 136 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who have undergone a liver biopsy for simple fatty liver or NASH and for which a serum sample is serum bank

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Known Cancer
  • Refusal of consent
  • Inflammatory disease
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
136 participants (actual)
Patient registry
No

Groups and cohorts

  • simple fatty liver

    patients with fatty liver disease

    Procedure: liver biopsy · Other: infrared spectroscopy

  • NASH

    patients with nonalcoholic steatohepatitis

    Procedure: liver biopsy · Other: infrared spectroscopy

Interventions

  • Procedureliver biopsy
  • Otherinfrared spectroscopy
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What researchers measure

Primary outcomes

  1. Sensitivity

    Evaluation of the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH with liver biopsy as a gold standard

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Centre hospitalier universitaire de Rennes
    Rennes, 35033, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02860884
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Aug 9, 2016
Start date
Aug 2014
Primary completion
Apr 2015
Completion
Oct 2015
Last update
Aug 9, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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