None listed
Conditions
Brief summary
Current understanding of colorectal carcinogenesis is based on the adenoma-carcinoma sequence, where genetics, intestinal microbiota changes and local immunity shifts play pivotal role. Despite the emerging evidence of dysbiotic state in patients with colorectal adenocarcinoma, early and advanced adenoma are rather less studied. Similarly, the immune infiltrates reflecting the extent of local immunity and inflammation are insufficiently examined in colorectal dysplastic lesions, as well. The purpose of this prospective cohort study (MIMICA-1) is, firstly, to identify the intestinal microbiota and immune infiltration patterns around the normal bowel tissue, early and advanced adenoma, carcinoma in situ, and adenocarcinoma, and secondly, to analyze the immune – microbiome interplay along the steps of conventional colorectal tumorigenesis.
Interventions
Participants: adult patients diagnosed with colorectal (CR) polyps, with data collected from the following 4 groups: (1) adenoma up and equal to 1 cm in diameter, (2) adenoma larger than 1 cm in diameter,(3) carcinoma in situ, (4) adenocarcinoma; and healthy patients as a (5)th control group.
Observational data collection: at first, all participants will have their feces collected prior to bowel preparation for colonoscopy or surgery. This will be performed from 2 weeks until the day of planned
Participants: adult patients diagnosed with colorectal (CR) polyps, with data collected from the following 4 groups: (1) adenoma up and equal to 1 cm in diameter, (2) adenoma larger than 1 cm in diameter,(3) carcinoma in situ, (4) adenocarcinoma; and healthy patients as a (5)th control group. Observational data collection: at first, all participants will have their feces collected prior to bowel preparation for colonoscopy or surgery. This will be performed from 2 weeks until the day of planned procedure. Thereafter, as a common management, and depending on specific colorectal dysplasia found, patients will receive either endoscopic polypectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), transanal endoscopic microsurgery (TEM), or bowel resection. During the procedure additional observational material will be collected for the study, i.e. bowel biopsy specimens from right- and left-sided colon, terminal ileum, and pathologic lesion, if present. Bowel sampling will take one day and the same patient’s visit for the planned interventional procedure of colorectal lesion removal. Therefore, data will be taken twice, once bowel tissue specimens collected at the mentioned procedure and one fecal sample collected two weeks beforehand.
Sponsors
Vilnius University Faculty of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Exposure groups: (1) Patients with histologically confirmed dysplastic colorectal lesion: early and advanced-adenoma, carcinoma in situ or adenocarcinoma (advanced adenomas are defined as those with high-grade dysplasia, villous or tubulovillous histology, equal to or greater than 1 cm in diameter); (2) Adult patients; (3) Written informed consent. Control (healthy) group: (1) Healthy patients (without any polypoid lesions found during screening colonoscopy) (2) Adult patients; (3) Written informed consent.
Exclusion criteria
Exclusion criteria (1) Patients under the age of 18 years; (2) Confirmed serrated (sessile serrated (SSA), traditional serrated adenomas (TSA)) or hyperplastic polyps or non-polypoid lesions; (3) Signs of colorectal tumor obturating the lumen of the bowel which would limit complete colonoscopy; (4) Suffer from other gastrointestinal tumors; (5) Pregnancy; (6) Previous colon resection; (7) History of surgery disrupting gastrointestinal tract integrity; (8) History of inflammatory bowel disease (ulcerative, Crohn’s, radiation-induced, or infectious colitis or other previous chronic inflammatory illnesses); (9) Familial adenomatous polyposis (FAP) or other hereditary colon syndromes; (10) Clinically significant immunodeficiency; (11) Evidence of infection; (12) During the last year patient had: - suffered from Cl. difficile colitis or was a carrier of Cl. difficile; suffered from salmonellosis or other gastrointestinal infection; - a long-term (> 6 months) use or recently completed therapeutic antibiotic course within the last month; - corticosteroid and/or immunosuppressant therapy; - received chemo- or radiation therapy in the abdomen and/or pelvis chemotherapy; - regular use (> 3 months) of pre-/pro-/(sin)biotics and/or statins; - a long-term (> 6 months) use of proton pump inhibitors; (13) Patients who cannot undergo colonoscopy on time and cannot cooperate fully.
Outcome results
None listed