EPIMURE: Prevalence of EGFR Mutations in epidermoïd Bronchopulmonary Cancers in Réunion Island

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Unknown status
CT.gov ID
NCT04261725
Collaborator
(none)
90
3
24
30
1.3

Study Details

Study Description

Brief Summary

Lung cancer is the most common cancer in the world with 1.8 million estimated incident cases in 2012 (12.9% of diagnosed cancers) and 1.6 million deaths annually. In mainland France, lung cancer represents 12% of all incident cancers. The standardized incidence rates for the world population were then 52.6 per 100,000 for men and 23.4 / 100,000 for women, respectively. In Reunion, 415 cases of primary bronchopulmonary cancers were reported for the years 2011-2012, which gives standardized incidence rates lower than those observed in mainland France (33.1 / 100,000 in humans, 8.2 / 100,000 in women).

If the incidence of bronchopulmonary cancer is lower in Réunion than in mainland France, the study of histological subtypes appears different: the investigators observe a greater frequency of adenocarcinomas (65% vs 45%), at the expense squamous cell carcinomas. In addition, for adenocarcinomas, the frequency of EGFR type mutations is twice as high (23% vs 11%). Thus, if this rate of EGFR mutations observed in mainland France is very close to those described in all Caucasian populations, that observed in the Reunionese population appears closer to those described in Asian populations, and more particularly the Indian population. This can perhaps be explained by the fact that the population of Reunion is a cosmopolitan and highly mixed race, whose share of Asian origin, mainly Indian and Chinese, is significant.

In clinical practice, INCa recommends carrying out the search for the EGFR mutation for any patient with locally advanced or metastatic lung carcinoma, not small cell and non epidermoid. This restriction to the histology of adenocarcinoma is justified by the low frequency of EGFR mutations for other histological types in Caucasian populations. However, some studies describe significant EGFR mutation rates for epidermoid cancers in Asian populations, particularly in India. Thus, given that a large part of the Réunion population shares Asian origins, the question of the frequency of EGFR mutations among squamous cell carcinomas in Réunion is asked.

The hypothesis of this research is that, given the ethnic characteristics of the Reunionese population, the proportion of bronchopulmonary epidermoid cancers carrying the EGFR mutation is potentially significantly higher than that observed in Caucasian populations, including the French metropolitan population. If this rate of EGFR mutations were high in the Reunion population, it would then be necessary to allow the search for this mutation to be extended to all bronchopulmonary cancers, which will improve their therapeutic management.

Condition or Disease Intervention/Treatment Phase
  • Genetic: EGFR mutation

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Prevalence of EGFR Mutations in epidermoïd Bronchopulmonary Cancers Diagnosed in Réunion
Actual Study Start Date :
Jan 6, 2020
Anticipated Primary Completion Date :
Jan 5, 2022
Anticipated Study Completion Date :
Jan 5, 2022

Arms and Interventions

Arm Intervention/Treatment
Squamous Cell Lung Cancer

Genetic analysis for searching EGFR mutation

Genetic: EGFR mutation
Searching the EGFR mutation in pulmonary biopsy

Outcome Measures

Primary Outcome Measures

  1. Prevalence of EGFR mutations among bronchopulmonary squamous cell carcinomas [1 month]

    Proportion of bronchopulmonary squamous cell carcinomas carrying the EGFR mutation among all bronchopulmonary squamous cell carcinomas treated at the CHU de la Réunion and at the Clinique Sainte Clotilde and whose histological diagnosis was carried out in one of the two laboratories anatomopathology of the University Hospital of Réunion.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • aged 18 and over,

  • who is diagnosed with bronchopulmonary squamous cell carcinoma in one of the 2 anatomopathology laboratories at Reunion University Hospital,

Exclusion Criteria:
  • refuses to participate in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hosiptalier Universitaire de La Réunion - site Nord Saint-Denis Réunion 97400
2 Centre Hospitalier niversitaire - site Sud Saint-Pierre Réunion 97410
3 Clinique Saint Clotilde Sainte-Clotilde Réunion 97400

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de la Réunion

Investigators

  • Principal Investigator: Michel ANDRE, MD, Centre Hospitalier Universitaire de la Réunion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT04261725
Other Study ID Numbers:
  • 2017/CHU/18
First Posted:
Feb 10, 2020
Last Update Posted:
Feb 10, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 10, 2020