Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238986
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-01-25
Brief Title:
Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy
Detailed Description:
PRIMARY OBJECTIVES
I To describe changes in GI inflammation and the GI microbiome profile in women with breast cancer throughout chemotherapy
II To examine how GI inflammation and GI microbiome changes influence symptom experience is used above in women with breast cancer receiving chemotherapy
III To examine associations between microbial composition functional profiles at T1 and T2 T3 as well as T4 in patients who report symptom severity in neuropsychological and GI symptoms at the last three timepoints
IV To evaluate for differentially abundant metabolites and perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report neuropsychological and GI symptom occurrence at T2 T3 and T4
OUTLINE This is an observational study
Patients undergo stool and blood sample collection complete questionnaires and have their medical records reviewed on study
I To describe changes in GI inflammation and the GI microbiome profile in women with breast cancer throughout chemotherapy
II To examine how GI inflammation and GI microbiome changes influence symptom experience is used above in women with breast cancer receiving chemotherapy
III To examine associations between microbial composition functional profiles at T1 and T2 T3 as well as T4 in patients who report symptom severity in neuropsychological and GI symptoms at the last three timepoints
IV To evaluate for differentially abundant metabolites and perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report neuropsychological and GI symptom occurrence at T2 T3 and T4
OUTLINE This is an observational study
Patients undergo stool and blood sample collection complete questionnaires and have their medical records reviewed on study
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23-007468 | OTHER | Mayo Clinic Institutional Review Board | None |
| NCI-2024-00288 | REGISTRY | None | None |