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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04261725
Other study ID # 2017/CHU/18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 24, 2020
Est. completion date January 18, 2022

Study information

Verified date January 2023
Source Centre Hospitalier Universitaire de la Réunion
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 18, 2022
Est. primary completion date January 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
EGFR mutation
Searching the EGFR mutation in pulmonary biopsy

Locations

Country Name City State
Réunion Centre Hosiptalier Universitaire de La Réunion - site Nord Saint-Denis
Réunion Centre Hospitalier niversitaire - site Sud Saint-Pierre
Réunion Clinique Saint Clotilde Sainte-Clotilde

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of EGFR mutations among bronchopulmonary squamous cell carcinomas Proportion of bronchopulmonary squamous cell carcinomas carrying the EGFR mutation among all bronchopulmonary squamous cell carcinomas treated at the CHU de la RĂ©union 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 RĂ©union. 1 month
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