Prevalence of Liver Fibrosis and Cirrhosis in Patients With Squamous Cell Carcinoma of the Head and Neck (fibr'HOM)
Primary Purpose
Liver Fibroses, Liver Cirrhoses, Squamous Cell Carcinoma of the Head and Neck
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of the hepatic fibrosis
Sponsored by
About this trial
This is an interventional other trial for Liver Fibroses
Eligibility Criteria
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
Sites / Locations
- CHU Amiens PicardieRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
prevalence of cirrhosis
Arm Description
Study the prevalence of cirrhosis in patients with VADS cancer
Outcomes
Primary Outcome Measures
Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer
Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer
Secondary Outcome Measures
Full Information
NCT ID
NCT03139058
First Posted
April 27, 2017
Last Updated
August 20, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03139058
Brief Title
Prevalence of Liver Fibrosis and Cirrhosis in Patients With Squamous Cell Carcinoma of the Head and Neck
Acronym
fibr'HOM
Official Title
Prevalence of Liver Fibrosis and Cirrhosis in Patients With Squamous Cell Carcinoma of the Head and Neck
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2018 (Anticipated)
Primary Completion Date
June 20, 2019 (Anticipated)
Study Completion Date
June 20, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibroses, Liver Cirrhoses, Squamous Cell Carcinoma of the Head and Neck
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prevalence of cirrhosis
Arm Type
Other
Arm Description
Study the prevalence of cirrhosis in patients with VADS cancer
Intervention Type
Other
Intervention Name(s)
Evaluation of the hepatic fibrosis
Intervention Description
Evaluation of the hepatic fibrosis stage by a hepatological assessment (Clinical, biological and imaging)
Primary Outcome Measure Information:
Title
Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer
Description
Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cyril PAGE, PhD
Phone
+33322668623
Email
page.cyril@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyril PAGE, PhD
Organizational Affiliation
CHU AMIENS PICARDIE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyril PAGE, PhD
Phone
+33322668623
Email
page.cyril@chu-amiens.fr
12. IPD Sharing Statement
Learn more about this trial
Prevalence of Liver Fibrosis and Cirrhosis in Patients With Squamous Cell Carcinoma of the Head and Neck
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