A Study to Develop a Cohort Database and Study Platform in Breast Cancer Survivors Using Multiscale Omics
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-005860
NCT ID: NCT04999826
Sponsor Protocol Number: 19-005860
About this study
The purpose of this study is to develop a breast cancer survivor (BCS) multiscale omics database that includes a complete fecal metagenome (gut microbiome) and fecal metabolome characterization.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult females enrolled in the Mayo Clinic Biospecimen Resource for Breast Disease (IRB # 1815-04).
- Current ages 18-75 years.
- Have a prior diagnosis of stage 0-3 (in situ or invasive) breast cancer (BCS).
- Have completed active therapy (surgery, radiation, and/or chemotherapy) (8-30 months approximately) prior to provision of the samples).
- Age-matched females with no history of cancer (other than non-melanoma skin cancer) may be selected from the PRISM Study (IRB #18-002366 The Predicting Risk after Screening Mammogram (PRISM) Study) or the Mayo Clinic Breast Mammography practice.
Exclusion Criteria:
- Male biological sex or gender.
- Pregnant females (insufficient #s, skewed estrogen levels).
- Unwilling to travel to Mayo Clinic Rochester to provide the blood and urine samples.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Brent Bauer, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available