Fusobacterium Nucleatum at Colorectal Cancer Sites

Not Applicable

Recruiting

• Conditions: Colorectal Cancer; Periodontitis

• Registration Number: NCT05945082
• Lead Sponsor: Malmö University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-29
• Status Verified: 2023-07
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-11
• Last Update Submitted: 2023-07-11
• Study First Posted: 2023-07-14
• Last Update Posted: 2023-07-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• diagnosis of colorectal cancer

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Presence of F.nucleatum in a colon cancer biopsy	At timepoint of biopsy	dichotomous (present / absent)

Trial Locations

Locations (1)

Skane University Hospital; 🇸🇪 Malmö, Sweden