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

Active, not recruiting

• Conditions: Anatomic 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 IIIA Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8
• Interventions: Procedure: Biospecimen Collection; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT04999826
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-11
• Primary Completion: 2022-12-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 105

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaire, biospecimen collection)	Biospecimen Collection	Participants complete questionnaires over 10 minutes and undergo blood, urine, saliva, and fecal samples collection.
Observational (questionnaire, biospecimen collection)	Quality-of-Life Assessment	Participants complete questionnaires over 10 minutes and undergo blood, urine, saliva, and fecal samples collection.
Observational (questionnaire, biospecimen collection)	Questionnaire Administration	Participants complete questionnaires over 10 minutes and undergo blood, urine, saliva, and fecal samples collection.

Primary Outcome Measures

Name	Time	Method
Utilization of multiscale omics to build a cohort database for breast cancer survivors	Up to study completion, up to 30 months

Secondary Outcome Measures

Name	Time	Method
Detection of unique patterns of variance	Up to study completion, up to 30 months	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States