ACTRN12624000976583进行中(未招募)Unknown
Colorectal adenoma-carcinoma sequence rediscovered: interaction of human gut microbiota and local immune system in health and carcinogenesis in adult patients
Vilnius University Faculty of Medicine0 个研究点目标入组 54 人开始时间: 2024年8月12日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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