Fusobacterium Nucleatum at Colorectal Cancer Sites

NCT05945082 | Unknown

• 1 other identifier: Dnr 2016/469
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Presence of F.nucleatum in a colon cancer biopsy

  dichotomous (present / absent)

  At timepoint of biopsy

Interventions

biopsy OTHER

biopsy of a colorectal cancer site

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of colorectal cancer

Sponsors & Collaborators

• Malmö University: lead
• Skane University Hospital: collaborator

Study Sites (1)

Skane University Hospital

Malmo, Sweden

RECRUITING

Related Publications (1)

• Plomp N, Bertl K, Lydrup ML, Sjoberg K, Harmsen HJM, Stavropoulos A. Does Fusobacterium in Colorectal Cancer Sites Originate From the Oral Cavity? A Pilot Study. Clin Exp Dent Res. 2024 Dec;10(6):e70016. doi: 10.1002/cre2.70016.

  PMID: 39491831 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Periodontitis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Kristina Bertl

CONTACT

00436645151194; kristina.bertl@mau.se

Andreas Stavropoulos

CONTACT

andreas.stavropoulos@mau.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 14, 2023
• Study Start: November 29, 2017
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

SE (1)