NCT03885648

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

7 years

First QC Date

March 15, 2019

Last Update Submit

July 2, 2024

Conditions

Breast Cancer

Keywords

Breast cancerMicrobiotaEndocrine disruptorsEstrogens

Outcome Measures

Primary Outcomes (2)

  • Metagenomic study of mammary microbiota

    Composition of bacteria, archaea, fungi and viruses present in breast tissue of women with breast cancer compared with that of women without breast cancer.

    December 31, 2020

  • Metagenomic study of intestinal microbiota

    Composition of bacteria, archaea, fungi and viruses present in stool samples of women with breast cancer compared with that of women without breast cancer.

    December 31, 2020

Secondary Outcomes (4)

  • Quantitation of the exposure to non-persistent EDCs (bisphenols) in urine samples

    December 31, 2020

  • Quantitation of the exposure to non-persistent EDCs (parabens) in urine samples

    December 31, 2020

  • Quantitation of the exposure to non-persistent EDCs (benzophenones) in urine samples

    December 31, 2020

  • Quantitation of urinary concentrations of estrogens

    December 31, 2020

Study Arms (2)

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.

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women diagnosed of breast cancer, stages I and II.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Mammary Pathology, General Surgery Service, University Hospital Campus de la Salud

Granada, 18100, Spain

Location

Related Publications (2)

  • Ruiz-Marin CM, Isabel Alvarez-Mercado A, Plaza-Diaz J, Rodriguez-Lara A, Gallart-Aragon T, Sanchez-Barron MT, Lartategui SR, Alcaide-Lucena M, Fernandez MF, Fontana L. A Clustering Study of Sociodemographic Data, Dietary Patterns, and Gut Microbiota in Healthy and Breast Cancer Women Participating in the MICROMA Study. Mol Nutr Food Res. 2024 Aug;68(15):e2400253. doi: 10.1002/mnfr.202400253. Epub 2024 Jul 1.

    PMID: 38950423RESULT

  • Plaza-Diaz J, Alvarez-Mercado AI, Ruiz-Marin CM, Reina-Perez I, Perez-Alonso AJ, Sanchez-Andujar MB, Torne P, Gallart-Aragon T, Sanchez-Barron MT, Reyes Lartategui S, Garcia F, Chueca N, Moreno-Delgado A, Torres-Martinez K, Saez-Lara MJ, Robles-Sanchez C, Fernandez MF, Fontana L. Association of breast and gut microbiota dysbiosis and the risk of breast cancer: a case-control clinical study. BMC Cancer. 2019 May 24;19(1):495. doi: 10.1186/s12885-019-5660-y.

    PMID: 31126257DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Mammary tissue, feces, urine and blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Luis Fontana, Ph.D.

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 21, 2019

Study Start

January 1, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

ES(1)