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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage 0 Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8

Intervention / Treatment
-----------------
* Procedure: Biospecimen Collection
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaire, biospecimen collection)<br>Participants complete questionnaires over 10 minutes and undergo blood, urine, saliva, and fecal samples collection. | Procedure: Biospecimen Collection<br>* Undergo biospecimen collection<br>* Other names: Biological Sample Collection;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization of multiscale omics to build a cohort database for breast cancer survivors |  | Up to study completion, up to 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to study completion, up to 30 months | 
| 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. | Up to study completion, up to 30 months | 
| 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. | Up to study completion, up to 30 months |