NCT00213603

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. 1.The probability of progression from an initially identified low grade lesion to a high grade lesion
  2. 2.The probability of respiratory epithelial tract progression assessed by the occurrence of a lung cancer or high grade lesion.
  3. 3.The characteristics of lung cancers detected in each arm
  4. 4.In both arm, the influence of risk factors and persistent exposure to tobacco on lesion evolutivity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

7.6 years

First QC Date

September 13, 2005

Last Update Submit

January 17, 2013

Conditions

Precancerous ConditionsThoracic Neoplasms

Keywords

precancerous lesionsLung cancerFollow-upRandomized studyAutofluorescence endoscopyprecancerous conditions

Outcome Measures

Primary Outcomes (1)

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

    3 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects at high risks for developping a lung cancer

You may qualify if:

  • 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

You may not qualify if:

  • Treatment with Vit A derivative
  • Contra indication for a fiberoptic bronchoscopy under local anesthesia.
  • Known evolutive cancer
  • Impossibility for a 3 years follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, Haute Normandie, 76000, France

Location

Related Publications (3)

  • Thiberville L, Moreno-Swirc S, Vercauteren T, Peltier E, Cave C, Bourg Heckly G. In vivo imaging of the bronchial wall microstructure using fibered confocal fluorescence microscopy. Am J Respir Crit Care Med. 2007 Jan 1;175(1):22-31. doi: 10.1164/rccm.200605-684OC. Epub 2006 Oct 5.

    PMID: 17023733RESULT

  • Guisier F, Deslee G, Birembaut P, Escarguel B, Chapel F, Bota S, Metayer J, Lachkar S, Capron F, Homasson JP, Taulelle M, Quintana M, Raspaud C, Messelet D, Benzaquen J, Hofman P, Baddredine J, Paris C, Cales V, Laurent P, Vignaud JM, Menard O, Copin MC, Ramon P, Bouchindhomme B, Tavernier JY, Quintin I, Quiot JJ, Galateau-Salle F, Zalcman G, Piton N, Thiberville L. Endoscopic follow-up of low-grade precancerous bronchial lesions in high-risk patients: long-term results of the SELEPREBB randomised multicentre trial. Eur Respir J. 2022 Sep 15;60(3):2101946. doi: 10.1183/13993003.01946-2021. Print 2022 Sep.

    PMID: 35236723DERIVED

  • Salaun M, Roussel F, Bourg-Heckly G, Vever-Bizet C, Dominique S, Genevois A, Jounieaux V, Zalcman G, Bergot E, Vergnon JM, Thiberville L. In vivo probe-based confocal laser endomicroscopy in amiodarone-related pneumonia. Eur Respir J. 2013 Dec;42(6):1646-58. doi: 10.1183/09031936.00191911. Epub 2012 Sep 27.

    PMID: 23018901DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

bronchial biopsies (fixed samples)

MeSH Terms

Conditions

Precancerous ConditionsThoracic NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

NeoplasmsNeoplasms by SiteRespiratory Tract NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Luc c Thiberville, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2002

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

FR(1)