NCT04999826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

July 22, 2021

Last Update Submit

December 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Utilization of multiscale omics to build a cohort database for breast cancer survivors

    Up to 5 years

Secondary Outcomes (3)

  • Detection of unique patterns of variance

    Up to 5 years

  • Detection of unique patterns of variance

    Up to 5 years

  • Detection of unique patterns of variance

    Up to 5 years

Study Arms (1)

Observational (questionnaire, biospecimen collection)

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

Procedure: Biospecimen CollectionOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Undergo biospecimen collection

Also known as: Biological Sample Collection
Observational (questionnaire, biospecimen collection)

Ancillary studies

Also known as: Quality of Life Assessment
Observational (questionnaire, biospecimen collection)

Complete questionnaires

Observational (questionnaire, biospecimen collection)

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with breast cancer stages 0 through 3 at time of diagnosis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, saliva, stool

MeSH Terms

Conditions

Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Carcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Brent A. Bauer, M.D.

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2021

First Posted

August 11, 2021

Study Start

April 1, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations