An observational study in Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by Mayo Clinic · Observational
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.
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.
142 studies on the registry are indexed under Breast Carcinoma In Situ; 26 are open to participants now.
This study's enrollment of 105 is below the median of 214 across 26 observational studies indexed under Breast Carcinoma In Situ.
Browse Breast Carcinoma In Situ studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with breast cancer stages 0 through 3 at time of diagnosis
Exclusion Criteria:
Participants complete questionnaires over 10 minutes and undergo blood, urine, saliva, and fecal samples collection.
Procedure: Biospecimen Collection · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Undergo biospecimen collection
Also known as: Biological Sample Collection
Ancillary studies
Also known as: Quality of Life Assessment
Complete questionnaires
Utilization of multiscale omics to build a cohort database for breast cancer survivors
Time frame: Up to 5 years
Detection of unique patterns of variance
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.
Time frame: Up to 5 years
Detection of unique patterns of variance
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.
Time frame: Up to 5 years
Detection of unique patterns of variance
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.
Time frame: Up to 5 years
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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