Colorectal NeoplasmsNCT06502704
Bile Acids and Microbiome in Early Colorectal Carcinogenesis
An observational study of Colorectal Neoplasms and Colorectal Cancer, run by Vilnius University at 1 site in Lithuania.
Trial summary
Currently colorectal cancer pathogenesis is mainly explained by the adenoma-carcinoma sequence theory that was proposed more than half a century ago. It mainly focuses on the explanation of genetic mutations that develop throughout the disease course. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Polyp
- How many people
- 60 participants
- Where
- 1 siteLithuania
- Study dates
- 5 Jul 2024to 1 Jan 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: > 18 years of age, atients that have clinical indications for colonoscopy.
Who may be able to join
- Patients that have clinical indications for colonoscopy
Who cannot join
- Pregnancy
- Immunocompromised
- Previously diagnosed colorectal diseases
- Radiotherapy to the pelvis
- Long term antibiotic use within 6 months
- Continuous use of proton pump inhibitors
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661
Tomas Poskus, PhD, +37052365000, Tomas.Poskus@santa.lt
Matas Jakubauskas, PhD, +37052365000, Matas.Jakubauskas@santa.lt
About this study
Official title: Bile Acids and Microbiome - Possible Novel Progression Factors and Diagnostic Indicators in Early Colorectal Carcinogenesis
Currently colorectal cancer pathogenesis is mainly explained by the adenoma-carcinoma sequence theory that was proposed more than half a century ago. It mainly focuses on the explanation of genetic mutations that develop throughout the disease course. However, several studies argue that there are also noticeable bile acid metabolism changes and microbiome composition changes within in colorectal cancer patients. However, carcinoma is the final step in the sequence, and prior steps are noticeably less well studied. Thus, the investigators hypothesize, that changes within microbiome and the changes in the urine, serum and gut bile acid composition further leads to the development of colorectal adenoma and subsequent invasive carcinoma.
Adult participants (15 per group) referred for colonoscopy and histologically diagnosed with small (<1cm) adenomas, large (>1cm) adenomas, invasive CRC will be included in the study, as well as 15 healthy controls. Fecal samples will be collected from all participants before bowel preparation. Additionally, urine and serum samples will be collected. Participants will undergo polypectomy, endoscopic mucosal resections, depending on the location, size and histology of the polyp found. During colonoscopy the mucosal biopsy specimens from the lesion and from the healthy bowel -terminal ileum, and colon will be obtained using sterile biopsy forceps. The collected samples will be stored for bile acid and microbiome analysis and for possible further pathology and genetic testing. Healthy participants without visible colorectum pathology during colonoscopy will undergo colon and terminal ileum mucosal sampling.
The investigators plan to evaluate the correlation between the urine and gut microbiome changes and bile acid composition and concentration in adenoma-carcinoma sequence and possibly determine novel bile acids. In addition, fecal, urine and tissue samples will be explored for gut microbiota and bile acid composition changes in healthy and along the adenoma-carcinoma sequence, with the possibility to propose a diagnostic test.
- Conditions
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Polyp, Microbiome, Bile Acid Malabsorption
- Keywords
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Polyp, Microbiome, Bile Acid
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | No pathology upon colonoscopy | |
| Small adenoma | < 1cm size polyp upon colonoscopy | |
| Large adenoma | > 1cm size polyp upon colonoscopy | |
| Cancer | Adenocarcinoma upon colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome and bile acid composition correlation to dysplastic changes
Microbiome and bile acid composition changes will be detected and correlated with progression of the dysplastic changes within the epithelium of the large bowel.
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Bile acid composition in healthy participants
Compare bile acid composition of healthy controls to patients with early and advanced adenomas and colorectal cancer, novel bile acid identification that could play a role in the adenoma-carcinoma sequence and identify the diagnostic potential of bile acid composition patterns
Measured: Through study completion, an average of 2 years
Bile acid composition in urine, stool and serum
Determine the bile acid composition in urine, stool and serum of healthy controls
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start5 Jul 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos
- Responsible party
- Sponsor
- Investigators
- Tomas Poskus, PhD, Principal investigator, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502704
- Sponsor's protocol ID
- 2024/5-1587-1047
- Status last verified
- Jul 2024
- First submitted
- 17 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bile Acids and Microbiome - Possible Novel Progression Factors and Diagnostic Indicators in Early Colorectal Carcinogenesis
- ClinicalTrials.gov ID
- NCT06502704
- Acronym / sponsor ID
- 2024/5-1587-1047
- Conditions
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Polyp, Microbiome, Bile Acid Malabsorption
- Keywords
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Polyp, Microbiome, Bile Acid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos
- Study start
- 5 Jul 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 16 Jul 2024 (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.
Currently colorectal cancer pathogenesis is mainly explained by the adenoma-carcinoma sequence theory that was proposed more than half a century ago. It mainly focuses on the explanation of genetic mutations that develop throughout the disease course. However, several studies argue that there are also noticeable bile acid metabolism changes and microbiome composition changes within in colorectal cancer patients. However, carcinoma is the final step in the sequence, and prior steps are noticeably less well studied. Thus, the investigators hypothesize, that changes within microbiome and the changes in the urine, serum and gut bile acid composition further leads to the development of colorectal adenoma and subsequent invasive carcinoma.
Adult participants (15 per group) referred for colonoscopy and histologically diagnosed with small (<1cm) adenomas, large (>1cm) adenomas, invasive CRC will be included in the study, as well as 15 healthy controls. Fecal samples will be collected from all participants before bowel preparation. Additionally, urine and serum samples will be collected. Participants will undergo polypectomy, endoscopic mucosal resections, depending on the location, size and histology of the polyp found. During colonoscopy the mucosal biopsy specimens from the lesion and from the healthy bowel -terminal ileum, and colon will be obtained using sterile biopsy forceps. The collected samples will be stored for bile acid and microbiome analysis and for possible further pathology and genetic testing. Healthy participants without visible colorectum pathology during colonoscopy will undergo colon and terminal ileum mucosal sampling.
The investigators plan to evaluate the correlation between the urine and gut microbiome changes and bile acid composition and concentration in adenoma-carcinoma sequence and possibly determine novel bile acids. In addition, fecal, urine and tissue samples will be explored for gut microbiota and bile acid composition changes in healthy and along the adenoma-carcinoma sequence, with the possibility to propose a diagnostic test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | –No pathology upon colonoscopy |
| Small adenoma | – | –< 1cm size polyp upon colonoscopy |
| Large adenoma | – | –> 1cm size polyp upon colonoscopy |
| Cancer | – | –Adenocarcinoma upon colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- > 18 years of age, atients that have clinical indications for colonoscopy.
Key inclusion criteria (1 listed)
- Patients that have clinical indications for colonoscopy
Key exclusion criteria (6 listed)
- Pregnancy
- Immunocompromised
- Previously diagnosed colorectal diseases
- Radiotherapy to the pelvis
- Long term antibiotic use within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiome and bile acid composition correlation to dysplastic changes
Time frame: Through study completion, an average of 2 years
Microbiome and bile acid composition changes will be detected and correlated with progression of the dysplastic changes within the epithelium of the large bowel.
2 secondary outcomes
Bile acid composition in healthy participants
Time frame: Through study completion, an average of 2 years
Bile acid composition in urine, stool and serum
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Tomas Poskus, PhD principal investigator
Vilnius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Colorectal Cancer, run by Vilnius University at 1 site in Lithuania.
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 6 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 16 Jul 2024. 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 Lithuania. 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 Tomas Poskus, PhD (+37052365000, Tomas.Poskus@santa.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome and bile acid composition correlation to dysplastic changes (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2024.