Immunological profiles in Inflammatory Bowel Disease - Immunological profiles in IBD

Rijnstate Ziekenhuis0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•- Patients with clinical symptoms of chronic diarrhoea, rectal blood loss, abdominal pain or weight loss who underwent ileocolonoscopy. Macroscopic findings during ileocolonoscopy must suggest IBD, such as erythema, mucosal friability, oedema an bleeding, erosions, superficial or deep ulcerations and luminal narrowing.
•- Ultimately, the diagnosis of IBD must be based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria.
•- Patients must be able and willing to provide written informed consent.
•- Patients above the age of 18, both men and women.
•- Known IBD patients under treatment during follow up.

•- Possible new IBD patients who use immunosuppressive medication 4 weeks prior to inclusion (e.g. corticosteroids and anti-TNF therapy) either for IBD, other autoimmune diseases or after organ transplantation.
•- Patients diagnosed with an immune suppressive disease.
•- Patients who underwent splenectomy in the past.
•- Patients diagnosed with any other autoimmune diseases (e.g. Diabetes Mellitus type I, rheumatoid arthritis, celiac disease, psoriasis, systemic lupus erythematosus).
•- Patients diagnosed with cancer including hematologic malignancies (e.g. (non-)Hodgkin lymphoma , leukemia), solid tumors and carcinoma in situ, within 5 years before screening with the following caveats:
•- Local basal or squamous cell carcinoma of the skin that has been excised and is considered cured is not exclusionary.
•- Chronic myelogenous leukemia, hairy cell leukemia, melanoma, renal cell carcinoma, or Kaposi sarcoma are exclusionary irrespective of the duration of time before screening.
•- Cervical smear indicating the presence of adenocarcinoma I situ (AIS), high-grade squamous intraepithelial lesions (HSIL), or cervical intraepithelial neoplasia (CIN) of grade>1, is exclusionary, irrespective of the duration of time before screening.
•- Follow up IBD-patients who underwent a total colectomy in the past.

发起方

Rijnstate Ziekenhuis