Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:40 AM
Study NCT ID:
NCT05700006
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2023-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
An Observational Study of Women With Breast Cancer Examining the Effect of Endocrine Therapy on Aging
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BETA
Brief Summary:
The goal of this pilot observational study is to learn about the feasibility of collecting patient-reported data and stool and blood samples from patients age 65 and older treated with aromatase inhibitor therapy for breast cancer. Participants will be treated with standard of care aromatase inhibitor therapy and will undergo serial phlebotomy, complete patient-reported questionnaires, and submit serial stool samples.
The main exploratory translational questions it aims to obtain preliminary data for are:
* What are the effects of aromatase inhibitor therapy on biomarkers of aging?
* What are the effects of aromatase inhibitor therapy on the microbiome? These data will be used for the development of future definitive studies.
The main exploratory translational questions it aims to obtain preliminary data for are:
* What are the effects of aromatase inhibitor therapy on biomarkers of aging?
* What are the effects of aromatase inhibitor therapy on the microbiome? These data will be used for the development of future definitive studies.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UMCC 2021.129 | OTHER | Rogel Cancer Center | View |