Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Randomized Trial to Assess the Impact of a Screening Program on Upper Aerodigestive Tract Cancer Mortality in a High Risk Population
This study is currently recruiting participants.
Verified by Institut Gustave Roussy, July 2006
Sponsored by: Institut Gustave Roussy
Information provided by: Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT00359645
  Purpose

Randomized multicenter trial to assess the impact of a screening program for heavy alcohol drinkers and smokers treated in alcohol addiction clinics on upper aerodigestive tract cancer mortality.


Condition Intervention Phase
Pharynx Cancer
Larynx Cancer
Oral Cavity Cancer
Oesophageal Cancer
Procedure: Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years
Phase III

MedlinePlus related topics: Alcoholism Cancer Esophageal Cancer Esophagus Disorders
Drug Information available for: Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: DEPISTORL - THANCS (Trial of Head And Neck Cancer Screening) Randomized Multicenter Trial to Assess the Impact of a Screening Program for Heavy Alcohol Drinkers and Smokers Treated in Alcohol Addiction Clinics on Upper Aerodigestive Tract Cancer Mortality.

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • Upper aerodigestive tract cancer mortality

Secondary Outcome Measures:
  • Screening test morbidity
  • Upper aerodigestive tract cancer incidence
  • Upper aerodigestive tract cancer stage

Estimated Enrollment: 20000
Study Start Date: August 2006
Detailed Description:

Upper aerodigestive tract (UADT) carcinomas (oral cavity and pharynx (63%), larynx (17%) and esophagus (20%)), are frequent in France with 25.000 new cases annually estimated in 2000, representing 13% of men cancer (3rd rank). Five-year specific survival rate is approximately 50% (11.000 deaths per year) and has not improved in over three decades, primarily due to the advanced stage at presentation. UADT cancers are also associated with profound disease- and treatment-related morbidity, with alterations in speech and feeding functions, aesthetic disability, with familial and social consequences.

The high-risk population is well characterized. A synergistic effect of tobacco smoking and alcohol drinking increases the risk of developing a carcinoma by more than 100 fold. Each year, 30.000 alcohol drinkers are treated in alcohol addiction clinics and could benefit from cancer detection. Nonrandomized pilot studies have showed that a UADT cancers screening trial could be undertaken in these clinics.

Study design: prospective randomized trial comparing an observation group and a screening group. Subjects in the screening group will undergo annual screening test including head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy with cytological examination during a 3-years period. In case of a positive test, patients will undergo head and neck panendoscopy and/or digestive flexible endoscopy and/or biopsy. After the screening period, subjects will be followed during 2 additional years by annual health questionnaires. Subjects of the observation group will be followed during 5 years by annual health questionnaires. Recruitment will be performed in alcohol addiction clinics and screening tests and confirmation exams in the closest specialized head and neck clinics.

The primary objective is to demonstrate a decrease in the UADT cancer mortality after a screening strategy, including head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy with cytological examination repeated annually during 3 years. Subjects will be followed during 5 years. A sample size of 10.000 subjects in each group allows the detection of a 33% reduction in the specific mortality rate, with a power of 80% and with a one sided a-risk of 5%.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • current or previous heavy smokers (smoked >= 20 years) and alcohol drinkers who need specialized care

Exclusion Criteria:

  • Head and neck clinical examination during the past 6 months
  • History of squamous cell carcinoma of the upper aero-digestive tract.
  • Recent digestive hemorrhage from varicose esophagus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359645

Contacts
Contact: Stéphane TEMAM, PhD 00 33 (0)14-211-4617 temam@igr.fr
Contact: Anne AUPERIN, MD 00 33(0)14-211-5499 auperin@igr.fr

Locations
France
Institut_Gustave-Roussy Recruiting
Villejuif, France, 94805
Contact: Stéphane TEMAM, PhD     00 33 (0)14-211-4617     temam@igr.fr    
Hopital Paul Brousse Recruiting
Villejuif, France, 94805
Contact: Laurent KARILA, MD     00 33 (0)14-559-3087     laurent.karila@pbr.aphp.fr    
CHU de Nancy Recruiting
Nancy, France, 54035
Contact: Hervé MARTINI, MD     00 33 (0)38-385-2421     h.martini@chu-nancy.fr    
Hopital de Saint Cloud Recruiting
Saint Cloud, France, 92
Contact: GEIGER-BOICHOT, MD            
CHU de Lille Not yet recruiting
Lille, France, 59
Contact: DANEL, MD            
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Stéphane TEMAM, PhD Institut Gustave Roussy
  More Information

Société Française de Cytologie Clinique  This link exits the ClinicalTrials.gov site
Société Française d'Alcoologie  This link exits the ClinicalTrials.gov site

Study ID Numbers: DEPISTORL - THANCS, CET 1172
Study First Received: August 1, 2006
Last Updated: July 15, 2008
ClinicalTrials.gov Identifier: NCT00359645  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Gustave Roussy:
Screening
Upper aerodigestive tract cancer
Alcohol
Tobacco
Randomized trial

Study placed in the following topic categories:
Behavior, Addictive
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Pharyngeal Neoplasms
Laryngeal Neoplasms
Pharyngeal Diseases
Digestive System Diseases
Respiratory Tract Diseases
Head and Neck Neoplasms
Alcoholism
Laryngeal carcinoma
Gastrointestinal Neoplasms
Stomatognathic Diseases
Esophageal Diseases
Laryngeal Diseases
Esophageal neoplasm
Ethanol

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009