Clinical trial · Observational
Multiscale Omics for the Development of a Cohort Database and Study Platform in Breast Cancer Survivors
Use of Multiscale Omics to Develop a Cohort Database and Study Platform in Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (22)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage 0 Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (questionnaire, biospecimen collection)
- description
- Participants complete questionnaires over 10 minutes and undergo blood, urine, saliva, and fecal samples collection.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Utilization of multiscale omics to build a cohort database for breast cancer survivors
- timeFrame
- Up to 5 years
Secondary outcomes (3)
- measure
- Detection of unique patterns of variance
- timeFrame
- Up to 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available