Colorectal CancerNCT05945082
Fusobacterium Nucleatum at Colorectal Cancer Sites
A study testing biopsy in people with Colorectal Cancer and Periodontitis, run by Malmö University at 1 site in Sweden.
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)… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer, Periodontitis
- What is being tested?
- biopsy
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 29 Nov 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of colorectal cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Andreas Stavropoulos contact
Sweden1 site, 1 recruiting
- Recruiting
Skane University Hospital
Malmö
Klas Sjöberg
About this study
Official title: Presence of Fusobacterium Nucleatum at Colorectal Cancer Sites - Influencing Factors and Screening Possibilities
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
- Being tested
- biopsy
- Medical subject headings
- Colorectal Neoplasms, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyOther
biopsy of a colorectal cancer site
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of F.nucleatum in a colon cancer biopsy
dichotomous (present / absent)
Measured: At timepoint of biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start29 Nov 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945082
- Sponsor's protocol ID
- Dnr 2016/469
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39491831
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of Fusobacterium Nucleatum at Colorectal Cancer Sites - Influencing Factors and Screening Possibilities
- ClinicalTrials.gov ID
- NCT05945082
- Acronym / sponsor ID
- Dnr 2016/469
- Conditions
- Colorectal Cancer, Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Skane University Hospital
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of colorectal cancer
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsybiopsy of a colorectal cancer site | Other | – |
Primary outcome
Presence of F.nucleatum in a colon cancer biopsy
Time frame: At timepoint of biopsy
dichotomous (present / absent)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Derived from this study: PubMed 39491831Plomp 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Stavropoulos contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy in people with Colorectal Cancer and Periodontitis, run by Malmö University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristina Bertl (00436645151194, kristina.bertl@mau.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of F.nucleatum in a colon cancer biopsy (time frame: At timepoint of biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05945082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.