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Follow-up Modalities of Low Grade Precancerous Bronchial Lesions

NCT00213603 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 365

Last updated 2013-01-18

No results posted yet for this study

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.

Conditions

  • Precancerous Conditions
  • Thoracic Neoplasms

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Luc c Thiberville, MD · University Hospital, Rouen

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00213603 on ClinicalTrials.gov