Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359645
Status:
COMPLETED
Last Update Posted:
2017-05-16
First Post:
2006-08-01
Brief Title:
Randomized Trial to Assess the Impact of a Screening Program on Upper Aerodigestive Tract Cancer Mortality in a High Risk Population
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Upper aerodigestive tract UADT carcinomas oral cavity and pharynx 63 larynx 17 and esophagus 20 are frequent in France with 25000 new cases annually estimated in 2000 representing 13 of men cancer 3rd rank Five-year specific survival rate is approximately 50 11000 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 30000 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 andor digestive flexible endoscopy andor 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 10000 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
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 30000 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 andor digestive flexible endoscopy andor 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 10000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CET 1172 | None | None | None |