Follow-up Modalities of Low Grade Precancerous Bronchial Lesions

• Register: ClinicalTrials.gov
• Last refreshed on: 21 January 2013
• Main ID: NCT00213603
• Date of registration: 13/09/2005
• Primary sponsor: University Hospital, Rouen
• Public title: Follow-up Modalities of Low Grade Precancerous Bronchial Lesions
• Scientific title: Endoscopic Follow-up of Low Grade Precancerous Bronchial Lesions in High Risk Patients (SELEPREBB1)
• Date of first enrolment: April 2002
• Target sample size: 365
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00213603
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

France

Contacts

• Name: Luc c Thiberville, MD
• Affiliation: Rouen University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient with one or several of the following risk factor for lung cancer:

- Tobacco consumption more than 30 pack years

- Lung or ENT cancer history, cured

- Occupational exposure to respiratory carcinogens

- Normal baseline CT scan

- Autofluorescence endoscopy showing moderate dysplasia or lower grade lesion

- Written informed consent

Exclusion Criteria:

- Treatment with Vit A derivative

- Contra indication for a fiberoptic bronchoscopy under local anesthesia.

- Known evolutive cancer

- Chest radiation therapy within 5 years before inclusion or chemotherapy within two
years before inclusion.

- Impossibility for a 3 years follow-up



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Precancerous Conditions

Thoracic Neoplasms

Primary Outcome(s)

occurence of high grade lesion or occurence of a cancer during endoscopic or clinical follow up [Time Frame: 3 years]

Secondary ID(s)

2001/032/HP

PHRC French ministry of Health

Source(s) of Monetary Support

Please refer to primary and secondary sponsors