Prevalence of Liver Fibrosis and Cirrhosis in Patients With Squamous Cell Carcinoma of the Head and Neck (fibr'HOM)

August 20, 2018 updated by: Centre Hospitalier Universitaire, Amiens
Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS). Among patients with VADS cancer, more than 60% reported daily alcohol consumption of more than 20 g / d. Such poisoning can be harmful, causing histological lesions of alcoholic liver disease, such as steatosis, alcoholic hepatitis, liver fibrosis and cirrhosis. In a population consuming more than 50 g of alcohol per day for 5 years, the prevalence of severe hepatic fibrosis is between 30% and 40%. In the therapeutic management of a cancer of VADS, the presence of cirrhosis is a prognostic element, increasing the postoperative risk of haemorrhage, surgical site infection and acute renal failure. The search for cirrhosis in the pre-therapeutic assessment is therefore important. The diagnosis of cirrhosis is not a problem when clinical, biological, radiological or endoscopic signs of hepatic insufficiency or portal hypertension are present. Asymptomatic cirrhosis is more difficult to diagnose without liver biopsy. Noninvasive hepatic exploration techniques have recently been developed and validated for the evaluation of liver fibrosis in the context of alcoholic liver disease. Fibroscan® (Echosens, Paris, France) is an imaging device for measuring the liver hardness (hepatic elasticity expressed in kPa), with a strong correlation with the presence of histological fibrosis of the liver. At the threshold of 19.5 kPa, Fibroscan can be used to diagnose cirrhosis with good diagnostic performance (Se 80%, Sp 90%, VPP 93%, VPN 70%) and good inter- and intra-observer reproducibility. Elastometry is a simple, reliable and non-invasive tool to systematically evaluate hepatic fibrosis in patients with VADS cancer. The examination can be performed during a routine care consultation. The post-therapeutic morbidity induced by cirrhosis in the cancers of VADS is not well known and there is no recommendation in France about the hepatic explorations to be carried out during the initial assessment of these neoplasias. It is essential to be able to specify this morbidity in order to adapt if necessary the therapeutic strategy of cancers of VADS.

The objective of this study is to systematically determine the presence of cirrhosis and / or liver fibrosis in patients with VADS cancer, in order to investigate their impact on the morbidity after treatment of squamous cell carcinomas of the head and neck.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient over 18 years of age
  • Supported in the department of Orl & CCF or Maxillo-Faciale surgery of the CHU d'Amiens

  • Histological diagnosis of epidermoid carcinoma:

    • From the oral cavity
    • From the oropharynx
    • Hypopharynx
    • Larynx
  • Any stage of cancer
  • Affiliation to a social security scheme

Exclusion Criteria:

  • Patient already treated previously for a cancer of the VADS
  • Patient referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: prevalence of cirrhosis
Study the prevalence of cirrhosis in patients with VADS cancer
Other: Evaluation of the hepatic fibrosis
Evaluation of the hepatic fibrosis stage by a hepatological assessment (Clinical, biological and imaging)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer
Time Frame: 1 day
Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire, Amiens

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cyril PAGE, PhD, CHU Amiens Picardie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI2016_843_0034

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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