NCT02860884

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
Last Updated

August 9, 2016

Status Verified

July 1, 2016

Enrollment Period

8 months

First QC Date

July 26, 2016

Last Update Submit

August 4, 2016

Conditions

Fatty LiverNon-alcoholic Fatty Liver Disease

Outcome Measures

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

    through study completion, an average of 1 year

Study Arms (2)

simple fatty liver

patients with fatty liver disease

Procedure: liver biopsyOther: infrared spectroscopy

NASH

patients with nonalcoholic steatohepatitis

Procedure: liver biopsyOther: infrared spectroscopy

Interventions

liver biopsyPROCEDURE
NASHsimple fatty liver
infrared spectroscopyOTHER
NASHsimple fatty liver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Known Cancer
  • Refusal of consent
  • Inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Fatty LiverNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 9, 2016

Study Start

August 1, 2014

Primary Completion

April 1, 2015

Study Completion

October 1, 2015

Last Updated

August 9, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)