EUCTR2006-005795-41-IT进行中（未招募）1 期
A CLINICO-PATHOLOGICAL PHASE II STUDY WITH TRANSLATIONAL ELEMENTS TOINVESTIGATE THE POSSIBLE INFECTIVE CAUSES OF NON-HODGKIN LYMPHOMA OF THE OCULAR ADNEXAE WITH PARTICULAR REFERENCE TO CHLAMYDIA SPECIES AND THE EFFECTS OF MALT LYMPHOMA TREATMENT WITH TETRACYCLINE - ND
INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP (IELSG)0 个研究点目标入组 100 人开始时间: 2007年6月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age 16 years or over
- •2. Histologically confirmed marginal zone B-cell lymphoma of MALT-type
- •3. Lymphoma localised to the ocular adnexae (conjunctiva, lacrymal gland, orbit soft tissue, clinical stage IEA) 4. No previous treatment, excepting RT for localised lymphoma of the contralateral eye
- •5. At least one measurable lesion
- •6. No systemic antibiotic therapy in the last three months
- •7. No other malignancy in the previous 5 years apart from appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •8. In women with reproductive potential a willingness to use contraception from entry
- •into the study for a period of 3 months
- •9. Written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant or lactating women
- •2. Known allergy to tetracycline
- •3. Patients unwilling to comply with the requirements of follow-up as defined by this protocol
- •4. Myasthenia gravis (tetracycline can exacerbate muscle weakness)
- •5. Systemic lupus erythematous (tetracycline can exacerbate the condition)
- •6. Patients with large or rapidly enlarging tumours requiring immediate radiotherapy
研究者
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