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Follow-up Modalities of Low Grade Precancerous Bronchial Lesions

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ClinicalTrials.gov Identifier: NCT00213603
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 18, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 21, 2005
Last Update Posted Date January 18, 2013
Study Start Date April 2002
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2013)
occurence of high grade lesion or occurence of a cancer during endoscopic or clinical follow up [ Time Frame: 3 years ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Follow-up Modalities of Low Grade Precancerous Bronchial Lesions
Official Title Endoscopic Follow-up of Low Grade Precancerous Bronchial Lesions in High Risk Patients (SELEPREBB1)
Brief Summary

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. 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.

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 evolutivity.
Detailed Description

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 evolutivity.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
bronchial biopsies (fixed samples)
Sampling Method Non-Probability Sample
Study Population subjects at high risks for developping a lung cancer
Condition
  • Precancerous Conditions
  • Thoracic Neoplasms
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 17, 2013)
365
Original Enrollment
 (submitted: September 13, 2005)
300
Actual Study Completion Date November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00213603
Other Study ID Numbers 2001/032/HP
PHRC French ministry of Health
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Rouen
Study Sponsor University Hospital, Rouen
Collaborators Not Provided
Investigators
Principal Investigator: Luc c Thiberville, MD Rouen University Hospital
PRS Account University Hospital, Rouen
Verification Date January 2013