Association of Breast and Gut Microbiota Dysbiosis and the Risk of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Metagenomic study of mammary microbiota
研究概览
简要总结
Breast cancer ranks first in women, and is the second cause of death in this gender. In addition to genetics, the environment contributes to the development of the disease, although the factors involved are not well known. Among the latter is the influence of microorganisms and, therefore, attention is recently being paid to the mammary microbiota. The hypothesis of this study is that the risk of breast cancer could be associated with the composition and functionality of the mammary/gut microbiota, and that exposure to environmental contaminants (endocrine disruptors, EDCs) might contribute to alter the microbiota.
This is a case-control clinical study that will be performed in women between 25 and 70 years of age. Cases will be women diagnosed and surgically intervened of breast cancer (stages I and II). Women with antecedents of cancer or advanced tumor stage (metastasis), or who have received antibiotic treatment within 3 months prior to recruitment, or any neoadjuvant therapy, will be excluded. Controls will be women surgically intervened of breast augmentation or reduction. Women with oncological, gynecological or endocrine history, and those who have received antibiotic treatment within 3 months prior to recruitment will also be excluded. Blood, urine, breast tissue and stool samples will be collected. Data regarding anthropometric, sociodemographic, reproductive history, tumor features and dietary habits will be gathered.
Metabolomic studies will be carried out in stool and breast tissue samples. Metagenomic studies will also be performed in stool and breast tissue samples to ascertain the viral, fungal, bacterial and archaea populations of the microbiota. Quantitation of estrogens, estrogen metabolites and EDCs in samples of serum, urine and breast tissue will also be performed.
This is the first time that the contribution of bacteria, archaea, viruses and fungi together with their alteration by environmental contaminants to the risk of breast cancer will be evaluated in the same study. Results obtained could contribute to elucidate risk factors, improve the prognosis, as well as to propose novel intervention studies in this disease.
详细描述
The study will follow the Declaration of Helsinki and the Spaniard legislation regarding clinical research. Data obtained will be confidential and only the researchers and participants, upon request, will have access to them. The study will also follow the data protection legislation of Spain to guarantee data confidentiality, treatment and availability.
Participation is volunteer. Participants will be informed about the nature of the research and the usage of biological samples. In addition to verbal information, participants will be presented and read an informed consent. Permission has been granted by the Ethics Committee of Andalusia (Spain).
Inclusion and exclusion criteria. Women's age will range 25-70 years. Cases will be women diagnosed and surgically intervened of incident breast cancer, stages I and II. Controls will be women surgically intervened of breast augmentation or reduction. Women with antecedents of cancer or advanced tumor stage (metastasis), or who have received antibiotic treatment 3 months prior to recruitment, or any neoadjuvant therapy, will be excluded of the study. Women with oncological, gynecological or endocrine antecedents and those who have received of antibiotic treatment 3 months prior to recruitment will be also excluded. Controls will be matched to cases by age (± 2 years), category of body mass index and hospital of recruitment.
Sample size. The number of breast cancer cases will include at least 100 women, matched with 100 control women. Three hospitals will participate in the recruitment: The University Hospital of Jaén, Spain; the University Hospital Campus de la Salud of Granada, Spain; and Ana Moreno Clinic (Granada, Spain).
Biological samples. Blood, breast tissue, stool and urine samples from cases and controls will be collected. Serum will be separated from blood by centrifugation. Breast tissue samples will be taken during surgery, from a marginal area 3-5 cm apart from the tumor. For controls, samples will be taken from any available breast tissue during breast reduction or augmentation surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Metagenomic study of mammary microbiota
时间窗: December 31, 2020
Composition of bacteria, archaea, fungi and viruses present in breast tissue of women with breast cancer compared with that of women without breast cancer.
Metagenomic study of intestinal microbiota
时间窗: December 31, 2020
Composition of bacteria, archaea, fungi and viruses present in stool samples of women with breast cancer compared with that of women without breast cancer.
次要结局
- Quantitation of the exposure to non-persistent EDCs (bisphenols) in urine samples(December 31, 2020)
- Quantitation of the exposure to non-persistent EDCs (benzophenones) in urine samples(December 31, 2020)
- Quantitation of the exposure to non-persistent EDCs (parabens) in urine samples(December 31, 2020)
- Quantitation of urinary concentrations of estrogens(December 31, 2020)
研究者
Luis Fontana
Full Professor, Ph. D., Department of Biochemistry and Molecular Biology II, School of Pharmacy, Campus de Cartuja s/n, 18071 Granada, Spain. Phone: +34958241000 Extension 20322 / +34958242318. E-mail: fontana@ugr.es
Universidad de Granada