Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213603
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2005-09-13
Brief Title:
Follow-up Modalities of Low Grade Precancerous Bronchial Lesions
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Endoscopic Follow-up of Low Grade Precancerous Bronchial Lesions in High Risk Patients SELEPREBB1
Status:
COMPLETED
Status Verified Date:
2013-01
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:
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
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 IRBethical comity approval This ancillary study is only performed at the Rouen University Hospital Center
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 IRBethical comity approval This ancillary study is only performed at the Rouen University Hospital Center
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 |
|---|---|---|---|
| PHRC French ministry of Health | None | None | None |