Clinical Trials Logo

Clinical Trial Summary

Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS).


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03139058
Study type Interventional
Source Centre Hospitalier Universitaire, Amiens
Contact Cyril PAGE, PhD
Phone +33322668623
Email page.cyril@chu-amiens.fr
Status Recruiting
Phase N/A
Start date August 20, 2018
Completion date June 20, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Recruiting NCT06236464 - Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas
Terminated NCT04659369 - Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC Phase 1
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT02572778 - Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Terminated NCT01488318 - Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma Phase 2
Active, not recruiting NCT00999700 - Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin Phase 3
Completed NCT02565758 - ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors Phase 1
Completed NCT02543476 - SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) N/A
Recruiting NCT03938012 - Evaluating Mutations in MET and TP53 Among Patients Diagnosed With Squamous Cell Carcinoma
Terminated NCT02124850 - A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab Phase 1
Active, not recruiting NCT03313804 - Priming Immunotherapy in Advanced Disease With Radiation Phase 2
Recruiting NCT05208762 - A Study of SGN-PDL1V in Advanced Solid Tumors Phase 1
Terminated NCT04453046 - Hemopurifier Plus Pembrolizumab in Head and Neck Cancer N/A
Completed NCT01758731 - Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History Phase 1
Completed NCT02473731 - A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients Phase 1
Completed NCT02022098 - Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial N/A
Completed NCT01458392 - Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck Phase 2
Completed NCT02882308 - Preoperative Administration of Olaparib With Cisplatin or With Durvalumab or Alone or no Tratment in Patients Who Are Candidates for Surgery of Carcinoma of the Head and Neck. Phase 2