跳至主要内容
临床试验/NCT06071572
NCT06071572招募中不适用

San Raffaele IBD Biobank: Accelerating Research From the Bed to the Bench Side

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
To perform DNA, RNA and protein extraction, cell isolation, serum isolation and metabolomic analysis from IBD patients blood, tissue, feces and saliva

研究概览

简要总结

The developments of knowledge and possibilities of investigation in the biomedical field, and in particularly in the field of inflammatory bowel diseases need to be analyzed and study vast cases of biological material carefully collected, preserved and correlated with complete clinical-pathological-instrumental data. In order to organize and make uniform the collection, storage and management of samples and the clinical data associated with them, a biobank is being set up, called "IBD Biobank" aimed at studying inflammatory intestinal diseases. THE subjects/patients who decide to authorize the collection, storage and use of biological material for future research purposes which are not currently identifiable will be called, in this document, donors. The IBD Biobank involves the recruitment of adult subjects. To each donor will be given informed consent DSAN 1178/6 ("Regulation e informed consent for the collection, conservation and use of human biological material spontaneous monocentric or multicentric studies with promoting OSR") or the most updated version of this informed consent, according to the directives of the OSR Ethics Committee. The biological material of the IBD Biobank will be processed at the laboratories of the Biological Resources Center (CRB) e preserved at BIOREP srl (Via Olgettina, 60, c/o San Raffaele Hospital-DIBIT2 - Palazzina San Michele 20132 Milan). Generally biological materials will be collected during the already scheduled surgery and the routine clinical examination as part of outpatient visits, day hospitals and hospital admissions. The biological samples will come stored in tubes equipped with barcode identification (2D) which guarantee a code unique to each rate and preserve its anonymity. The clinical-pathological-instrumental data, demographic and anamnestic information will be entered by trained personnel on a computerized database anonymously by assigning a UPN code identifying the patient. Access the database is managed via personal login and password. All data entered is recorded and stored on the server of the IRCCS San Raffaele Hospital in Milan.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with IBD (min 18 years)

排除标准

  • Patients without IBD

结局指标

主要结局

To perform DNA, RNA and protein extraction, cell isolation, serum isolation and metabolomic analysis from IBD patients blood, tissue, feces and saliva

时间窗: 1-36

In particular, the analysis are: Tissue: DNA, RNA and protein extraction, cell isolation Blood: DNA, RNA and protein extraction, cell isolation and serum isolation Feces: DNA and RNA extraction, metabolomic analysis Saliva: DNA and RNA extraction

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvio Danese

Director of Gastroenterology and Endoscopy Unit

IRCCS San Raffaele

研究点 (1)

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