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

Sponsor
Mayo Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04999826
Collaborator
National Cancer Institute (NCI) (NIH)
105
Enrollment
1
Location
33
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:
  1. 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 Design

Study Type:
Observational
Actual Enrollment :
105 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Use of Multiscale Omics to Develop a Cohort Database and Study Platform in Breast Cancer Survivors
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Observational (questionnaire, biospecimen collection)

Participants complete questionnaires over 10 minutes and undergo blood, urine, saliva, and fecal samples collection.

Procedure: Biospecimen Collection
Undergo biospecimen collection
Other Names:
  • Biological Sample Collection

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Complete questionnaires

    Outcome Measures

    Primary Outcome Measures

    1. Utilization of multiscale omics to build a cohort database for breast cancer survivors [Up to study completion, up to 30 months]

    Secondary Outcome Measures

    1. 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 multivariate analysis applied to the large data sets developed in this trial.

    2. 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 machine learning tools applied to the large data sets developed in this trial.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Brent A Bauer, Mayo Clinic in Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04999826
    Other Study ID Numbers:
    • 19-005860
    • NCI-2021-07536
    • 19-005860
    • P30CA015083
    First Posted:
    Aug 11, 2021
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Breast Carcinoma In Situ

    Study Results

    No Results Posted as of Aug 4, 2022