Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05748145
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-01-26
Brief Title:
Metronidazole as Preoperative Therapy in CRC FusoMetro-001
Sponsor:
Oncology Institute of Southern Switzerland
Organization:
Oncology Institute of Southern Switzerland
Study Overview
Official Title:
Preoperative Treatment With Metronidazole to Evaluate the Efficacy in Reducing Fusobacterium Nucleatum Tumor Colonization in Patients With Colorectal Cancer CRC a Proof-of-concept Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The proposed proof-of concept trial aims at determining the effectiveness of metronidazole in decreasing the Fusobacterium nucleatum load in tissues and possibly on its detrimental effects on tumor cells and tumor microenvironment
Detailed Description:
Colorectal cancer CRC is among the most frequent tumor types and is a leading cause of cancer-related death worldwide Surgery represents the first therapeutic option whereas advanced cases are usually treated by established chemotherapy protocols yet with variable response rates
Mechanisms underlying unresponsiveness are still largely unclear Recently the gut microbiota consisting of trillions of microorganisms which populate the gastrointestinal tract has also been implicated in chemo-resistance
Defined bacterial species have been reported to be associated with CRC In particular Fusobacterium nucleatum Fn a commensal bacterium of the oral cavity is enriched in CRC tissues and its abundance appears to be associated with reduced patient survival
In experimental models Fn promotes CRC cell proliferation and reduces tumor responsiveness to 5-fluorouracil 5-FU Furthermore it suppresses tumor infiltration by immune cells associated with improved prognosis
Administration of metronidazole effectively reduces Fn load and overall tumor growth in animal models
However its efficacy in reducing Fn loads in human CRC has not been verified so far
The proposed proof-of concept trial aims at determining the effectiveness of metronidazole in decreasing the Fn load in tissues and possibly on its detrimental effects on tumor cells and tumor microenvironment
Mechanisms underlying unresponsiveness are still largely unclear Recently the gut microbiota consisting of trillions of microorganisms which populate the gastrointestinal tract has also been implicated in chemo-resistance
Defined bacterial species have been reported to be associated with CRC In particular Fusobacterium nucleatum Fn a commensal bacterium of the oral cavity is enriched in CRC tissues and its abundance appears to be associated with reduced patient survival
In experimental models Fn promotes CRC cell proliferation and reduces tumor responsiveness to 5-fluorouracil 5-FU Furthermore it suppresses tumor infiltration by immune cells associated with improved prognosis
Administration of metronidazole effectively reduces Fn load and overall tumor growth in animal models
However its efficacy in reducing Fn loads in human CRC has not been verified so far
The proposed proof-of concept trial aims at determining the effectiveness of metronidazole in decreasing the Fn load in tissues and possibly on its detrimental effects on tumor cells and tumor microenvironment
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