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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 25, 2019
Sponsor:
Information provided by (Responsible Party):
Luis Fontana, Universidad de Granada

Brief Summary:

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
Breast Cancer

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
Cases
Women's age will range 25-70 years. Cases will be women diagnosed and surgically intervened of breast cancer, stages I and II.
Controls
Controls will be women surgically intervened of breast augmentation or reduction.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Quantitation of the exposure to non-persistent EDCs (bisphenols) in urine samples [ Time Frame: December 31, 2020 ]
    Concentrations (ng/mL) of Bisphenols.

  2. Quantitation of the exposure to non-persistent EDCs (parabens) in urine samples [ Time Frame: December 31, 2020 ]
    Concentrations (ng/mL) of parabens

  3. Quantitation of the exposure to non-persistent EDCs (benzophenones) in urine samples [ Time Frame: December 31, 2020 ]
    Concentrations (ng/mL) of benzophenones

  4. Quantitation of urinary concentrations of estrogens [ Time Frame: December 31, 2020 ]
    Concentrations (ng-pg/ml) of estrogens.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women diagnosed of breast cancer, stages I and II.
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  1. For cases:

    • Women with antecedents of cancer or advanced tumor stage (metastasis).
    • Women who have received antibiotic treatment 3 months prior to recruitment, or any neoadjuvant therapy.
  2. For controls:

    • Women with oncological, gynecological or endocrine antecedents.
    • Women who have received antibiotic treatment 3 months prior to recruitment.

Information from the National Library of Medicine

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


Contacts
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Contact: Luis Fontana, Ph. D. +34958241000 ext 20322 fontana@ugr.es

Locations
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Spain
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    fontana@ugr.es   
Sub-Investigator: Mariana F Fernandez, Ph.D.         
Sponsors and Collaborators
Universidad de Granada
Investigators
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Principal Investigator: Luis Fontana, Ph.D. Universidad de Granada

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT03885648     History of Changes
Other Study ID Numbers: PI-0538-2017
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Luis Fontana, Universidad de Granada:
Breast cancer
Microbiota
Endocrine disruptors
Estrogens

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases