Multiscale Omics for the Development of a Cohort Database and Study Platform in Breast Cancer Survivors

December 23, 2025 updated by: Mayo Clinic

Use of Multiscale Omics to Develop a Cohort Database and Study Platform in Breast Cancer Survivors

This study gathers information to create a database to improve the ability to diagnose cancer, predict long term health of breast cancer patients, and help develop future treatment products. This study will provide a foundational platform for therapeutic development and intervention studies in the future and may for therapeutic development and intervention studies in the future, and may advance researchers understanding of the contribution gut bacteria to altered circulating estrogens in breast cancer survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To use multiscale omics to build a cohort database that can be used as a reference population in support of multivariate analysis, predictive modeling, and development of natural product therapeutics and precision medicine applications for breast cancer survivors.

SECONDARY OBJECTIVE:

I. To detect unique patterns of variance between 1) targeted serum metabolites, 2) plasma metabolome, 3) gut microbiome community structure, 4) gut microbiome metabolome, 5) urine metabolome, 6) quality of life measures, and 7) breast cancer survivors (BCS) symptoms by using multivariate analysis, machine learning tools, and artificial intelligence applied to the large data sets developed in this trial.

OUTLINE:

Participants complete questionnaires over 10 minutes and undergo blood, urine, saliva, and fecal samples collection.

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with breast cancer stages 0 through 3 at time of diagnosis

Description

Inclusion Criteria:

  • BCS GROUP
  • Female patients diagnosed with breast cancer age 18 - 75, stages 0 through 3 at time of diagnosis
  • Who have completed active therapy (including surgery, radiation, and/or chemotherapy)
  • Able to speak English and complete surveys and provide the specimen (willing to follow the sample collection instructions)
  • Able to read, understand and sign inform consent
  • CONTROL GROUP
  • Healthy Volunteers age 18 - 75
  • Able to speak and read English, complete consent, surveys, and provide specimens

Exclusion Criteria:

  • Unable to give written consent
  • Unable to fast before providing blood and urine
  • Pregnant women (per participant report) and males
  • Unwilling to travel to Mayo Clinic Rochester to provide bio specimens

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (questionnaire, biospecimen collection)
Participants complete questionnaires over 10 minutes and undergo blood, urine, saliva, and fecal samples collection.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Complete questionnaires
Procedure: Biospecimen Collection
Undergo biospecimen collection
Other Names:
  • Biological Sample Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Utilization of multiscale omics to build a cohort database for breast cancer survivors
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of unique patterns of variance
Time Frame: Up to 5 years
Will be detected between 1) serum metabolites, 2) plasma metabolome, 3) gut microbiome community structure, 4) gut microbiome metabolome, 5) urine metabolome, 6) quality of life measures, and 7) BCS symptoms by using multivariate analysis applied to the large data sets developed in this trial.
Up to 5 years
Detection of unique patterns of variance
Time Frame: Up to 5 years
Will be detected between 1) serum metabolites, 2) plasma metabolome, 3) gut microbiome community structure, 4) gut microbiome metabolome, 5) urine metabolome, 6) quality of life measures, and 7) BCS symptoms by using machine learning tools applied to the large data sets developed in this trial.
Up to 5 years
Detection of unique patterns of variance
Time Frame: Up to 5 years
Will be detected between 1) serum metabolites, 2) plasma metabolome, 3) gut microbiome community structure, 4) gut microbiome metabolome, 5) urine metabolome, 6) quality of life measures, and 7) BCS symptoms by using artificial intelligence applied to the large data sets developed in this trial.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Brent A. Bauer, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

July 22, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-005860 (Mayo Clinic in Rochester)
  • NCI-2021-07536 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anatomic Stage I Breast Cancer AJCC v8

Clinical Trials on Quality-of-Life Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe