Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06126003
Status:
TERMINATED
Last Update Posted:
2024-04-08
First Post:
2023-11-06
Brief Title:
Gut and Tumor Microbiome in Patients With Early Stage II-III Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer
Sponsor:
BioCorteX Inc
Organization:
BioCorteX Inc
Study Overview
Official Title:
A Multi-center 2-arm Observational Study Exploring the Role of the Gut and Tumor Microbiome in the Differential Immune Profile of Patients With Early Stage II-III Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer Arm-1
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not reach enrollment goals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to collect samples of blood and stool and analyse primary tumor from participants with breast cancer to see how the bacteria in the body affect cancer and how well it responds to treatment By comparing samples and data from multiple participants with breast cancer it may be possible to identify how a persons gut health and tumor microenvironment affects how they respond to certain cancer treatments
Detailed Description:
After being informed about the study and potential risks all participants giving written informed consent will provide a pre-treatment stool sample looking at the gut microbiome primary tumor sequencing analysis to infer tumor microbiome and a blood sample for the CyTOF whole blood Immune Profile Blood tests full blood count renal profile liver profile C-reactive protein medical history concomitant medications and the Eastern Cooperative Oncology Group ECOG performance level will be obtained through a mixture of self-reported and data collated from the electronic health record EHR Two food frequency questionnaires will be given to participants to complete at two timepoints at screening and at end of study There are 5 study visits Participants will provide a stool sample for gut microbiome sequencing at weeks 2 and 4 of the study During the Week 6 visit participants will provide final stool samples for gut microbiome analysis and a blood sample for CyTOF whole blood Immune Profile ECOG performance status and adverse event data will be obtained from EHR
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?:
None
Is an FDA AA801 Violation?:
None