NL-OMON40487已完成不适用
Protocol to obtain tumor biopsies from patients with locally advanced (incurable) or metastatic cancer to improve selection for clinical trials. - CPCT-05 biopsy protocol patient selection
niversitair Medisch Centrum Utrecht0 个研究点目标入组 1,500 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
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 至 99（—）
入选标准
- •1. Patients with cancer who are eligible to enter into a trial with systemic anti-cancer therapy. A CPCT-05 biopsy may be combined with a diagnostic biopsy at all instances, if deemed appropriate for selection for study participation.Exempt from biopsy: glioblastoma patients who have undergone surgery with adequate histological material available for identification of tumor specific mutations.
- •2. Histologic biopsy can safely be obtained:
- •a. Patients with safely accessible lesions according to the medical specialist performing the biopsy procedure.
- •b. Patients not known should not have with known bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgeries.
- •c. Patients must not using use any anti-coagulant medication at the time of biopsy: all aspirin derivatives, NSAID*s, coumarines, platelet function inhibitors, heparins (including LMWHs) and oral factor Xa inhibitors are not allowed, unless medication can either be safely stopped or counteracted. If the medical specialist performing the biopsy of a superficial lesion agrees with performing the biopsy procedure while the patient is on anticoagulant therapy other than therapeutically dosed coumarines, LMWHs and oral Xa inhibitors, the biopsy may be performed with caution.
- •d. Adequate hematology and coagulation status as measured by
- •:i. Hb > 6.0 mmol/L
- •Note: Red blood cell transfusions are allowed to increase the Hb.
- •Platelet count >100 x 109/L
- •ii. PT < 1.5 x ULN or PT-INR < 1.5
- •iii. APTT < 1.5 x ULN
- •iv. On the day of biopsy in patients using coumarines: PT-INR < 1.5
- •e. Biopsies should be performed at least four weeks after last bevacizumab administration (only in patients previously treated with bevacizumab).
- •3. Patients not known with contraindications for lidocaine (or its derivatives) or (in case of endoscopic guided biopsy procedure) midazolam and phentanyl.
- •4. Patients with adequate organ function as measured by:
- •a. Adequate liver function (only in case of planned liver biopsy):
- •i. Total bilirubin < 1.5 x ULN (except in case of documented Gilbert*s disease)
- •b. Adequate renal function (only in case of planned kidney biopsy):
- •i. Creatinine < 1.5 x ULN or
- •ii. Creatinine clearance (calculated by Cockroft) > 60 mL/min
- •5. WHO performance status 0-2
- •6. Patients age > 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent.
排除标准
- •defined as positive selection criteria
研究者
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