Squamous Cell Lung CancerEPIMURENCT04261725
Prevalence of EGFR Mutations in epidermoïd Bronchopulmonary Cancers in Réunion Island
An observational study of Squamous Cell Lung Cancer, run by Centre Hospitalier Universitaire de la Réunion at 3 sites in Reunion.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Lung Cancer
- What is being tested?
- EGFR mutation
- How many people
- 60 participants
- Where
- 3 sitesReunion
- Study dates
- 24 Feb 2020to 18 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are diagnosed with bronchopulmonary squamous cell carcinoma in one of the 2 anatomopathology laboratories at Reunion University Hospital
Who may be able to join
- aged 18 and over,
- who is diagnosed with bronchopulmonary squamous cell carcinoma in one of the 2 anatomopathology laboratories at Reunion University Hospital,
Who cannot join
- refuses to participate in the study
Trial locations and contacts
3 sites in 1 country.
Reunion3 sites
Centre Hosiptalier Universitaire de La Réunion - site Nord
Saint-Denis, 97400
Centre Hospitalier niversitaire - site Sud
Saint-Pierre, 97410
Clinique Saint Clotilde
Sainte-Clotilde, 97400
About this study
Official title: Evaluation of the Prevalence of EGFR Mutations in epidermoïd Bronchopulmonary Cancers Diagnosed in Réunion
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.
Read more
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.
- Conditions
- Squamous Cell Lung Cancer
- Being tested
- EGFR mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR mutationGenetic
Searching the EGFR mutation in pulmonary biopsy
| Study group | Role | What they receive |
|---|---|---|
| Squamous Cell Lung Cancer | Genetic analysis for searching EGFR mutation Receives: Genetic: EGFR mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start24 Feb 2020
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel ANDRE, MD, Principal investigator, Centre Hospitalier Universitaire de la Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261725
- Sponsor's protocol ID
- 2017/CHU/18
- Acronym
- EPIMURE
- Status last verified
- Jan 2023
- First submitted
- 6 Feb 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of EGFR Mutations in epidermoïd Bronchopulmonary Cancers Diagnosed in Réunion
- ClinicalTrials.gov ID
- NCT04261725
- Acronym / sponsor ID
- EPIMURE / 2017/CHU/18
- Conditions
- Squamous Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Squamous Cell Lung Cancer | – | Genetic: EGFR mutationGenetic analysis for searching EGFR mutation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with bronchopulmonary squamous cell carcinoma in one of the 2 anatomopathology laboratories at Reunion University Hospital
Key inclusion criteria (2 listed)
- aged 18 and over,
- who is diagnosed with bronchopulmonary squamous cell carcinoma in one of the 2 anatomopathology laboratories at Reunion University Hospital,
Key exclusion criteria (1 listed)
- refuses to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGFR mutationSearching the EGFR mutation in pulmonary biopsy | Genetic | Squamous Cell Lung Cancer |
Primary outcome
Prevalence of EGFR mutations among bronchopulmonary squamous cell carcinomas
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel ANDRE, MD principal investigator
Centre Hospitalier Universitaire de la Réunion
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Lung Cancer, run by Centre Hospitalier Universitaire de la Réunion at 3 sites in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of EGFR mutations among bronchopulmonary squamous cell carcinomas (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.