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NCT01461070

Intestine Bacteria and Breast Cancer Risk

Completed Last updated 27 May 2020
What this trial tests

trial in Breast Neoplasms in 175 participants. Completed in 22 May 2020.

Timeline
10 August 2011
Primary endpoint
30 June 2014
22 May 2020

Quick facts

Lead sponsorNational Cancer Institute (NCI)
StatusCompleted
Study typeOBSERVATIONAL
Enrollment175
Start date10 August 2011
Primary completion30 June 2014
Estimated completion22 May 2020
Sites1 location across United States

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 50 to 69, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: \- Some bacteria found in the large and small intestines help keep people healthy and aid digestion. They may also affect a person s risk of developing cancer. Researchers want to study the relationship between intestinal bacteria and breast cancer risk factors. They can do this by looking at stool and urine samples from postmenopausal women. Objectives: \- To study intestinal bacteria and its relationship to urine-based markers of breast cancer risk in women. Eligibility: \- Women between 55 and 69 years of age with a recent mammogram that showed no signs of cancer. Design: * Participants will be screened with a medical history and basic health questionnaire. * At home, participants will complete questionnaires about cancer risk factors and food consumption. * Participants will also collect urine and stool samples. They will send the samples to the designated labs for study. * No treatment will be provided as part of this protocol.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The gut microbiota in breast cancer development and treatment: The good, the bad, and the useful!
    Nandi D, Parida S, Sharma D. · · 2023 · cited 55× · PMID 37305949 · DOI 10.1080/19490976.2023.2221452
  2. Gut Microbiota and Breast Cancer: The Dual Role of Microbes.
    Álvarez-Mercado AI, Del Valle Cano A, Fernández MF, Fontana L. · · 2023 · cited 50× · PMID 36672391 · DOI 10.3390/cancers15020443
  3. Modulating Microbiota as a New Strategy for Breast Cancer Prevention and Treatment.
    Wu H, Ganguly S, Tollefsbol TO. · · 2022 · cited 40× · PMID 36144329 · DOI 10.3390/microorganisms10091727
  4. Role of Gut Microbiota in Breast Cancer and Drug Resistance.
    Viswanathan S, Parida S, Lingipilli BT, Krishnan R, et al · · 2023 · cited 38× · PMID 36986390 · DOI 10.3390/pathogens12030468
  5. Opportunities and Challenges of the Human Microbiome in Ovarian Cancer.
    Cheng H, Wang Z, Cui L, Wen Y, et al · · 2020 · cited 27× · PMID 32133297 · DOI 10.3389/fonc.2020.00163
  6. Emulating interactions between microorganisms and tumor microenvironment to develop cancer theranostics.
    Jiang T, Yang T, Chen Y, Miao Y, et al · · 2022 · cited 18× · PMID 35401838 · DOI 10.7150/thno.70719
  7. Microbiome-targeted nanoplatforms and engineering approaches in breast cancer therapy.
    Sabeel Z, Yang Z. · · 2025 · cited 2× · PMID 41168838 · DOI 10.1186/s12943-025-02456-x

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Other recruiting trials for Breast Neoplasms

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Data sources for this page

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