Follow-up Modalities of Low Grade Precancerous Bronchial Lesions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213603
First received: September 13, 2005
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.

Condition
Precancerous Conditions
Thoracic Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Follow-up of Low Grade Precancerous Bronchial Lesions in High Risk Patients (SELEPREBB1)

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • occurence of high grade lesion or occurence of a cancer during endoscopic or clinical follow up [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

bronchial biopsies (fixed samples)


Enrollment: 365
Study Start Date: April 2002
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

subjects at high risks for developping a lung cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213603

Locations
France
Rouen University Hospital
Rouen, Haute Normandie, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Luc c Thiberville, MD Rouen University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213603     History of Changes
Other Study ID Numbers: 2001/032/HP, PHRC French ministry of Health
Study First Received: September 13, 2005
Last Updated: January 17, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Rouen:
precancerous lesions
Lung cancer
Follow-up
Randomized study
Autofluorescence endoscopy
precancerous conditions

Additional relevant MeSH terms:
Precancerous Conditions
Thoracic Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 01, 2014