Breast Cancer Clinical Trial

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

Summary

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

105

Study ID:

NCT04999826

Recruitment Status:

Active, not recruiting

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

105

Study ID:

NCT04999826

Recruitment Status:

Active, not recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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