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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04999826
• Other study ID #: 19-005860
• Secondary ID: NCI-2021-07536
• Status: Active, not recruiting
• Start date: April 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• 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
• Breast Carcinoma In Situ
• Breast Neoplasms
• 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

Procedure:
• Biospecimen Collection
Undergo biospecimen collection

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utilization of multiscale omics to build a cohort database for breast cancer survivors		Up to study completion, up to 30 months
Secondary	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
Secondary	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
Secondary	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