Breast Cancer and Its Relationship With the Microbiota (MICROMA)
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|ClinicalTrials.gov Identifier: NCT03885648|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 24, 2020
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Association of Breast and Gut Microbiota Dysbiosis and the Risk of Breast Cancer|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2022|
Women's age will range 25-70 years. Cases will be women diagnosed and surgically intervened of breast cancer, stages I and II.
Controls will be women surgically intervened of breast augmentation or reduction.
- Metagenomic study of mammary microbiota [ Time Frame: 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 [ Time Frame: 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.
- Quantitation of the exposure to non-persistent EDCs (bisphenols) in urine samples [ Time Frame: December 31, 2020 ]Concentrations (ng/mL) of Bisphenols.
- Quantitation of the exposure to non-persistent EDCs (parabens) in urine samples [ Time Frame: December 31, 2020 ]Concentrations (ng/mL) of parabens
- Quantitation of the exposure to non-persistent EDCs (benzophenones) in urine samples [ Time Frame: December 31, 2020 ]Concentrations (ng/mL) of benzophenones
- Quantitation of urinary concentrations of estrogens [ Time Frame: December 31, 2020 ]Concentrations (ng-pg/ml) of estrogens.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885648
|Contact: Luis Fontana, Ph. D.||+34958241000 ext firstname.lastname@example.org|
|Unit of Mammary Pathology, General Surgery Service, University Hospital Campus de la Salud||Recruiting|
|Granada, Spain, 18100|
|Contact: Luis Fontana, Ph. D. +34958241000 ext 20322 email@example.com|
|Sub-Investigator: Mariana F Fernandez, Ph.D.|
|Principal Investigator:||Luis Fontana, Ph.D.||Universidad de Granada|