Interaction of human gut microbiota and local immune system in health and progression of colorectal adenoma (MIMICA-1)

Not Applicable

Active, not recruiting

• Conditions: Colorectal cancer (adenocarcinoma); Colorectal adenoma (simple and advanced); Colorectal carcinoma in situ; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12624000976583
• Lead Sponsor: Vilnius University Faculty of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified