Multiscale Omics for the Development of a Cohort Database and Study Platform in Breast Cancer Survivors
NCT ID: NCT04999826
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
105 participants
OBSERVATIONAL
2021-04-01
2022-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (questionnaire, biospecimen collection)
Participants complete questionnaires over 10 minutes and undergo blood, urine, saliva, and fecal samples collection.
Biospecimen Collection
Undergo biospecimen collection
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaires
Interventions
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Biospecimen Collection
Undergo biospecimen collection
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Complete questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 fast before providing blood and urine
* Pregnant women (per participant report) and males
* Unwilling to travel to Mayo Clinic Rochester to provide bio specimens
18 Years
75 Years
FEMALE
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Brent A. Bauer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2021-07536
Identifier Type: REGISTRY
Identifier Source: secondary_id
19-005860
Identifier Type: -
Identifier Source: org_study_id