Randomized Trial to Assess the Impact of a Screening Program on Upper Aerodigestive Tract Cancer Mortality in a High Risk Population
NCT ID: NCT00359645
Last Updated: 2017-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1993 participants
INTERVENTIONAL
2006-06-21
2015-12-18
Brief Summary
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Detailed Description
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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%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
Annual auto questionnaire
No interventions assigned to this group
Screening
Annual screening of Head and Neck cancer
Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years
Interventions
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Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of squamous cell carcinoma of the upper aero-digestive tract.
* Recent digestive hemorrhage from varicose esophagus
40 Years
ALL
Yes
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Principal Investigators
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Stéphane TEMAM, PhD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Centre Hospitalier MONTPERRIN
Aix-en-Provence, , France
CHIAB Annemasse Bonneville
Annemasse, , France
Centre Hospitalier d'ARRAS
Arras, , France
CHS de L'Yonne
Auxerre, , France
Chg Beziers
Béziers, , France
C.A.S.A.
Clermont, , France
CHU Hôpital Gabriel Montpied
Clermont-Ferrand, , France
Centre Hospitalier de DIEPPE
Dieppe, , France
CHU le Bocage
Dijon, , France
Centre Hospitalier Louis Sevestre
La Membrolle-sur-Choisille, , France
Centre Hospitalier du Mans
Le Mans, , France
Centre Hospitalier de LENS
Lens, , France
CHU de Lille
Lille, , France
CHBS Lorient
Lorient, , France
Centre hospitalier Lyon sud
Lyon, , France
Centre Hospitalier des Chanaux
Mâcon, , France
CHU de Nancy
Nancy, , France
CHU de Nantes
Nantes, , France
Hôpital ARCHET II
Nice, , France
Centre ANPAA d'Orléans
Orléans, , France
Centre Paul Cézanne
Orléans, , France
Hôpital de la Source
Orléans, , France
Clinique Philae
Pont-Péan, , France
Centre Hospitalier du Centre Bretagne
Pontivy, , France
Centre ANPAA 51 de Reims
Reims, , France
CHU Hôpital Pontchaillou
Rennes, , France
Hopital de Saint Cloud
Saint-Cloud, , France
CHR de la Réunion
Saint-denis de La Reunion, , France
Ch Saint-Egreve
Saint-Égrève, , France
Centre de soins de suite Marienbronn
Soultz-sous-Forêts, , France
CHU de Strasbourg - Hôpital Hautepierre
Strasbourg, , France
Hôpitaux du Leman
Thonon-les-Bains, , France
Chba Vannes
Vannes, , France
Hopital Paul Brousse
Villejuif, , France
Institut_Gustave-Roussy
Villejuif, , France
Countries
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Other Identifiers
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CET 1172
Identifier Type: -
Identifier Source: secondary_id
DEPISTORL - THANCS
Identifier Type: -
Identifier Source: org_study_id
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