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NCT05945082 Clinical Trial

Fusobacterium Nucleatum at Colorectal Cancer Sites

Colorectal Cancer Clinical Trial

Official title:
Presence of Fusobacterium Nucleatum at Colorectal Cancer Sites - Influencing Factors and Screening Possibilities

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05945082
Other study ID # Dnr 2016/469
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 29, 2017
Est. completion date December 31, 2025

Study information
Verified date July 2023
Source Malmö University
Contact Kristina Bertl
Phone 00436645151194
Email kristina.bertl@mau.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recent studies suggest an association of periodontitis with an overall increased cancer risk but also with cancer development in specific anatomic regions, such as in the colon. The gut microbiome in general and specifically Fusobacterium nucleatum have been described to likely affect colorectal cancer (CRC) development. The present project intends to evaluate the possible contribution of the oral cavity as a reservoir for dissemination of F.nucleatum to the colon. Additionally, the gut microbiome and dietary intake will be assessed as possible factors influencing colonization of CRC sites with F. nucleatum and an association of F.nucleatum colonization in the colon with parameters in the saliva and serum will be tested. One-hundred-fifty patients diagnosed with CRC will be included; after cancer diagnosis and before starting cancer treatment a periodontal examination will be done and saliva and serum samples and at the time-point of tumor resection a biopsy of the CRC sites will be collected.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria: - diagnosis of colorectal cancer

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• biopsy
biopsy of a colorectal cancer site

Locations
Country Name City State
Sweden Skane University Hospital Malmö

Sponsors (2)
Lead Sponsor Collaborator
Malmö University Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of F.nucleatum in a colon cancer biopsy dichotomous (present / absent) At timepoint of biopsy
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