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Endoscopic Follow-up of Low Grade Precancerous Bronchial Lesions in High Risk Patients (SELEPREBB1)

18 Years
80 Years
Not Enrolling
Precancerous Conditions, Thoracic Neoplasms

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Trial Information

Endoscopic Follow-up of Low Grade Precancerous Bronchial Lesions in High Risk Patients (SELEPREBB1)

The goal of this multicentric French randomized trial is to determine the best auto
fluorescence bronchial endoscopic follow-up strategy in high risk patients bearing low grade
bronchial precancerous lesions. This Trial compares two follow-up modalities : observation
without endoscopy for a three year period (group A " light " follow-up), versus repeated
autofluorescence endoscopies and biopsies every six months for three years (group B "
intensive ").

Methods: 300 subjects at high risk for lung cancer will be included over a two year period
and followed-up for three years. In each subject an auto-fluorescence endoscopy and a Chest
CT scan will be performed before the enrollment into the trial. To be included the subject
must present with an initial Chest CT scan not suspicious for lung cancer and bronchial
biopsy showing a moderate dysplasia or a lower grade lesion.

Subjects will be randomly assigned to one of the following arm :

(A) every 6 months clinical and chest Xrays follow-up without intermediate endoscopy, (B)
every 6 months clinical and chest Xrays follow-up including repeated autofluorescence
endoscopy and biopsies on a 6 months basis in case of low grade dysplasia or on a one year
basis in patients without dysplasia.

Stratifications factors for randomization are: Center, occupational exposure to respiratory
carcinogens, presence of a bronchial low dysplastic lesion versus absence of dysplasia.

Bronchial biopsies samples will be centrally reviewed by a panel of Pathologists.

After 36 months follow-up, each patient from the two groups will be subjected to a final
autofluorescence endoscopy and biopsy and a Spiral Chest Xray.

The final analysis will compare between the two groups :

1. The probability of progression from an initially identified low grade lesion to a high
grade lesion

2. The probability of respiratory epithelial tract progression assessed by the occurrence
of a lung cancer or high grade lesion.

3. The characteristics of lung cancers detected in each arm

4. In both arm, the influence of risk factors and persistent exposure to tobacco on lesion

First inclusion into the trial : July 2002, End of recruitment December 2005, End of follow-
up : december 2008.

An ancillary study analysing the performances of fibered confocal fluorescence microscopy
has been started in december 2005 after IRB/ethical comity approval. This ancillary study is
only performed at the Rouen University Hospital Center.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

occurence of high grade lesion or occurence of a cancer during endoscopic or clinical follow up

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Luc c Thiberville, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rouen University Hospital


France: Ministry of Health

Study ID:




Start Date:

April 2002

Completion Date:

November 2009

Related Keywords:

  • Precancerous Conditions
  • Thoracic Neoplasms
  • precancerous lesions
  • Lung cancer
  • Follow-up
  • Randomized study
  • Autofluorescence endoscopy
  • precancerous conditions
  • Neoplasms
  • Precancerous Conditions
  • Thoracic Neoplasms