Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-01 @ 6:57 AM
Study NCT ID:
NCT03702868
Status:
TERMINATED
Last Update Posted:
2021-01-29
First Post:
2018-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
A Prospective Cohort Study of Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty accruing subjects the study accrual was closed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy.
The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.
The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.
Detailed Description:
Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy.
The human gut microbiota have been considered the most important microecosystem living in symbiosis with the body. It is identified as a crucial determinant in cancer occurrence and development . Besides, Gut microbial alterations may influence the therapy efficacy and adverse drug event.
We collect the fresh tail stool sample 24h before adjuvant chemotherapy and 24h after adjuvant chemotherapy then the composition of intestinal microbiota and subsequent short-term alterations are analysed by 16srRNA sequencing.The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.
The human gut microbiota have been considered the most important microecosystem living in symbiosis with the body. It is identified as a crucial determinant in cancer occurrence and development . Besides, Gut microbial alterations may influence the therapy efficacy and adverse drug event.
We collect the fresh tail stool sample 24h before adjuvant chemotherapy and 24h after adjuvant chemotherapy then the composition of intestinal microbiota and subsequent short-term alterations are analysed by 16srRNA sequencing.The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.
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?: