Mechanisms of Cancerogenesis of Woodworkers Adenocarcinomas (ADK-FO)
Mechanisms of Cancerogenesis for Woodworkers Adenocarcinomas: Transcriptional Study of Olfactory Cleft Cells of Patients Exposed or Not to Wood Dust
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Pilot study, single center, prospective and retrospective, aiming to better understand the mechanisms of carcinogenesis of nasal adenocarcinoma among 2 groups of subjects based on their potential risk of nasal adenocarcinoma.
Patients will be recruited prospectively, in the ENT department (Prof. R. JANKOWSKI-Institut Lorrain Heart and vessels Louis Mathieu -Hospitals Brabois-CHU Nancy), during a visit for another medical reason.
They will be divided into 2 groups as follows:
- Group 1: NON EXPOSED : control group: patients not exposed to wood dust (low risk)
- Group 2: EXPOSED: patients exposed to wood dust (high risk)
After complete information, inclusion in the study will be proposed to patients
If inclusion is accepted, patients will undergo, during the nasal fiber endoscopy (performed for care), and under local anesthesia (performed for care), a brushing of the most accessible olfactory clef (performed for research). These samples will be compared to tumor samples which are already available (REFCOR)
The samples of groups 1 and 2 will be sent directly to the laboratory of Pathological Anatomy Cytology (Pr-J.M. VIGNAUD Hospital Brabois- CHU Nancy). They will briefly vortexed (5 min) and frozen. They will be kept in the laboratory of Pathological Anatomy Cytology (Pr-J.M. VIGNAUD Hospital Brabois- CHU Nancy) until analysis. The samples will be transferred from the laboratory of Pathological Anatomy Cytology (Pr-J.M. VIGNAUD Hospital Brabois- CHU Nancy) to the Genomics Platform (INSERM, U954, Prof. JL GUEANT- Faculty of Medicine, University of Lorraine), for analysis.
RNA will be extracted from olfactory cells , using RNeasy Mini kit (Qiagen) with DNase treatment. The concentration and purity of the DNA / RNA will be measured (OD at 230nm, 260nm and 280nm) with a Nanodrop spectrophotometer (Nyxor). The RNA integrity will be determined from the profiles of ribosomal RNAs (18S & 28S) measured on LabOnChip® (2100 Bioanalyzer System, Agilent Technologies). The RNA samples will be stored at -80 ° C until use.
The transcriptome analysis will be conducted on chips Whole Human Genome 60K * 8 developed by Agilent®, and according to the manufacturer's protocol (single-color Agilent protocol).
At the end of the research samples will be destroyed.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Vandoeuvre Les Nancy, Франция, 54511
- Service ORL-CHRU NANCY
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Male, > 50 years
- No known tumor
- patient needing fiberendoscopy, but for nasal pathology
- informed consent given
- affiliation to a healthcare scheme compulsory
- prior medical exam 'NON EXPOSED' group: no wood dust exposure 'EXPOSED' group : wood dust exposure > 20 years with delay since the beginning of exposure > 30 years
Exclusion criteria:
- Prior radiotherapy on sinus or nasal fossa
- Inflammatory disease of nasal fossa
- Genetic disease with cancer risk (xeroderma pigmentosum, chromosomal abnormality deletion or translocation, DNA repair deficiency)
- No informed consent
- No affiliation to a healthcare scheme compulsory
- prior medical exam
- Contra-indication to Xylocaine
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
NON EXPOSED
Male, >50 years, unexposed to wood dust, without any nasal pathology, without known tumor -> Brushing of the olfactory cleft |
Non invasive sampling of olfactory cleft cells, by brushing under local anesthesia during fiberendoscopy Form: survey of acceptability
|
|
EXPOSED
Male, >50 years, exposed to wood dust, without any nasal pathology, without known tumor -> Brushing of the olfactory cleft |
Non invasive sampling of olfactory cleft cells, by brushing under local anesthesia during fiberendoscopy Form: survey of acceptability
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The identification of expression profiles specific of wood dust exposure (comparison of both groups (exposed / non exposed))
Временное ограничение: through study completion, an average of 1 year
|
Descriptive data (Mean, Median, Min, Max).
Comparison of gene expression levels ( Ttest ) of both groups: identification of expression profiles specific of each group (Ftest)
|
through study completion, an average of 1 year
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The identification of expression profiles predictive of a nasal adenocarcinoma transformation.
Временное ограничение: through study completion, an average of 1 year
|
Comparison of gene expression levels of the 15 exposed patients with known gene expression levels of 15 tumor samples (intestinal adenocarcinomas related to wood dust) (T Test) Identification of common modifications of gene expression (Ftest)
|
through study completion, an average of 1 year
|
|
The acceptability of the brushing technique
Временное ограничение: through study completion, an average of 1 year
|
The acceptability will be evaluated on a composite criterion with three sub-criteria
|
through study completion, an average of 1 year
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Patrice Gallet, MD, CHRU NANCY
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2015-A02004-45
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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