An observational study in Colorectal Neoplasms, Colorectal Cancer and Colorectal Polyp, sponsored by Vilnius University. Recruiting at 1 site in Lithuania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by Vilnius University · Observational
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 60 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Vilnius University is the lead sponsor of 61 studies on the registry; 11 are open to participants now.
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> 18 years of age, atients that have clinical indications for colonoscopy.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No pathology upon colonoscopy
\< 1cm size polyp upon colonoscopy
\> 1cm size polyp upon colonoscopy
Adenocarcinoma upon colonoscopy
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.
Time frame: Through study completion, an average of 2 years
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
Time frame: 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
Time frame: Through study completion, an average of 2 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2024; primary completion for Jan 2025, 5 months later.
Of 528 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's planned 5 months is below that.
Counting every sponsor, half of 645 studies reached it within 51 months; a quarter within 27 and three quarters within 104.
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