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Fusobacterium Nucleatum at Colorectal Cancer Sites

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ClinicalTrials.gov Identifier: NCT05945082
Recruitment Status : Recruiting
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
Sponsor:
Collaborator:
Skane University Hospital
Information provided by (Responsible Party):
Malmö University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Periodontitis Other: biopsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Presence of Fusobacterium Nucleatum at Colorectal Cancer Sites - Influencing Factors and Screening Possibilities
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Intervention Details:
  • Other: biopsy
    biopsy of a colorectal cancer site

Outcome Measures
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Primary Outcome Measures :
  1. Presence of F.nucleatum in a colon cancer biopsy [ Time Frame: At timepoint of biopsy ]
    dichotomous (present / absent)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of colorectal cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05945082


Contacts
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Contact: Kristina Bertl 00436645151194 kristina.bertl@mau.se
Contact: Andreas Stavropoulos andreas.stavropoulos@mau.se

Locations
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Sweden
Skane University Hospital Recruiting
Malmö, Sweden
Contact: Klas Sjöberg         
Sponsors and Collaborators
Malmö University
Skane University Hospital
More Information
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Responsible Party: Malmö University
ClinicalTrials.gov Identifier: NCT05945082    
Other Study ID Numbers: Dnr 2016/469
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Periodontitis
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