NCT00359645

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,993

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_3

Geographic Reach
1 country

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2015

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

9.5 years

First QC Date

August 1, 2006

Last Update Submit

May 15, 2017

Conditions

Pharynx CancerLarynx CancerOral Cavity CancerOesophageal Cancer

Keywords

ScreeningUpper aerodigestive tract cancerAlcoholTobaccoRandomized trial

Outcome Measures

Primary Outcomes (1)

  • Upper aerodigestive tract cancer mortality

    5 years

Secondary Outcomes (3)

  • Screening test morbidity

    1 week

  • Upper aerodigestive tract cancer incidence

    5 years

  • Upper aerodigestive tract cancer stage

    5 years

Study Arms (2)

Control

NO INTERVENTION

Annual auto questionnaire

Screening

EXPERIMENTAL

Annual screening of Head and Neck cancer

Procedure: Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 years

Interventions

Screening by head and neck clinical examination with a fiberoptic nasolaryngoscopy and an oesopharyngeal brush biopsy annually during 3 yearsPROCEDURE
Screening

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Centre Hospitalier MONTPERRIN

Aix-en-Provence, 13100, France

Location

CHIAB Annemasse Bonneville

Annemasse, 74 100, France

Location

Centre Hospitalier d'ARRAS

Arras, 62000, France

Location

CHS de L'Yonne

Auxerre, 89000, France

Location

Chg Beziers

Béziers, 34525, France

Location

C.A.S.A.

Clermont, 60600, France

Location

CHU Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Centre Hospitalier de DIEPPE

Dieppe, 76200, France

Location

CHU le Bocage

Dijon, 21034, France

Location

Centre Hospitalier Louis Sevestre

La Membrolle-sur-Choisille, 37390, France

Location

Centre Hospitalier du Mans

Le Mans, 72037, France

Location

Centre Hospitalier de LENS

Lens, 62300, France

Location

CHU de Lille

Lille, 59, France

Location

CHBS Lorient

Lorient, 56322, France

Location

Centre hospitalier Lyon sud

Lyon, 69, France

Location

Centre Hospitalier des Chanaux

Mâcon, 71, France

Location

CHU de Nancy

Nancy, 54035, France

Location

CHU de Nantes

Nantes, 44, France

Location

Hôpital ARCHET II

Nice, 06202, France

Location

Centre ANPAA d'Orléans

Orléans, 45000, France

Location

Centre Paul Cézanne

Orléans, 45000, France

Location

Hôpital de la Source

Orléans, 45067, France

Location

Clinique Philae

Pont-Péan, 35131, France

Location

Centre Hospitalier du Centre Bretagne

Pontivy, 56306, France

Location

Centre ANPAA 51 de Reims

Reims, 51100, France

Location

CHU Hôpital Pontchaillou

Rennes, 35033, France

Location

Hopital de Saint Cloud

Saint-Cloud, 92, France

Location

CHR de la Réunion

Saint-denis de La Reunion, 97405, France

Location

Ch Saint-Egreve

Saint-Égrève, 38521, France

Location

Centre de soins de suite Marienbronn

Soultz-sous-Forêts, 67250, France

Location

CHU de Strasbourg - Hôpital Hautepierre

Strasbourg, 67098, France

Location

Hôpitaux du Leman

Thonon-les-Bains, 74200, France

Location

Chba Vannes

Vannes, 56000, France

Location

Hopital Paul Brousse

Villejuif, 94805, France

Location

Institut_Gustave-Roussy

Villejuif, 94805, France

Location

Related Links

MeSH Terms

Conditions

Pharyngeal NeoplasmsLaryngeal NeoplasmsMouth NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsMouth DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Stéphane TEMAM, PhD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2006

First Posted

August 2, 2006

Study Start

June 21, 2006

Primary Completion

December 18, 2015

Study Completion

December 18, 2015

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

FR(35)