Search for Olfactory Cells Within the Fetal Ethmoid Epithelium
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Immunohistological positive signal of primary olfactive neurons
研究概览
简要总结
The recent rhinological functional approach known as "Evo-Devo" leads us to consider the nose not as a single organ, but as the construction of a specifically olfactory organ within which functional respiratory structures have developed over the course of species evolution in the same way they develop during human embryogenesis.
In adult humans, the olfactory structures are limited to two narrow regions situated at the upper part of the nasal passages known as olfactory clefts. Nevertheless, phylogenetic evidence indicates that these olfactory clefts are vestiges of an olfactory organ that once occupied the entire ethmoid bone in the front of the skull base.
The hypothesis of this study posits that, during the embryological development of the ethmoid bone, it would initially be covered with olfactory mucosa, which would gradually diminish as the lateral masses of the ethmoid formed, eventually persisting exclusively within the olfactory clefts of the ethmoid by the conclusion of the first trimester (end of organogenesis). Besides their fundamental interest, the results of this study could help understand the still unknown pathogenesis of nasal polyposis, a chronic anosmic disease with a prevalence of 2 to 4% in the French and European population.
This study requires a series of ethmoidal samples from human fetuses at various ages between 7 and 15 weeks of gestational age. Specific immunohistological labeling techniques under standard optical microscopy will be used to search for and quantify olfactory nerve cells within the fetal ethmoidal mucosa.
详细描述
This research project is based on the hypothesis that olfactory epithelium is present within the mucosa of the lateral ethmoid masses, similar to the olfactory fissures at the beginning of the fetal organogenesis period, gradually disappearing before the end of the first trimester in the lateral ethmoid masses as they form.
This study aims to be descriptive, with the objective of identifying this fetal olfactory epithelium and assessing its distribution changes within the ethmoidal mucosa as fetal age progresses.
The chosen method for conducting this study relies on histological analysis using a standard optical microscope of fetal ethmoids (whole bodies or only the cephalic extremity depending on sample size) to preserve their architecture. Microscopic analysis will be coupled with immunohistochemistry or immunofluorescence techniques to characterize the cells of interest: primary olfactory neurons.
Sample collection will be prospective, with the recruitment of fetuses spread over the course of the study, spanning 18 to 24 months. The anticipated minimum sample size is 20 cases. Intermediate analyses are planned in case of non-contribution of samples or if there are a sufficient number of samples to meet the primary and secondary objectives.
The samples are fetal products obtained from either medical or surgical induced abortion procedures, with a gestational age of a minimum of 7 weeks amenorrhea and up to 14 weeks + 6 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Weeks 至 15 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fetus aged at least 7 weeks of gestation up to 14 weeks + 6 days.
- •Fetus resulting from an in-hospital procedure of voluntary termination of pregnancy, either medicinal or surgical.
- •Fetus whose mother is of legal age and legally responsible.
- •Fetus whose mother has been provided with fair and complete information about the research conducted and has given informed, voluntary, and written consent for the use of fetal products from the voluntary termination of pregnancy procedure she is undergoing.
- •Fetus whose mother has not objected to the utilization of data derived from the research.
排除标准
- •Fetus macroscopically exhibiting a craniofacial malformation
结局指标
主要结局
Immunohistological positive signal of primary olfactive neurons
时间窗: Once a series of 10 recruited samples is assembled, ca. 10 month
次要结局
- Concentration of primary olfactory neurons immunohistological signals(Once a series of 10 recruited samples is assembled, ca. 10 month)
研究者
JANKOWSKI Roger
Professor
Central Hospital, Nancy, France
