ChiCTR1900021581尚未招募1 期
癌症治療後口腔和腸道微生物群變化的觀察性研究
香港中文大學1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年3月5日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Changes in gut and oral microbial community profiles measured by 16s and metagenomics sequencing before and after cancer therapy.
研究概览
简要总结
Primary objective:
- Delineate changes in gut and oral microbial community profiles of cancer therapy patients before and after therapy. Secondary objectives:
- Correlate baseline gut and oral microbial community profiles with the origin of primary tumours;
- Correlate changes in gut and oral microbial community profiles with the development of toxicity;
- Compare gut and oral microbial community profiles between cancer patients and age-/sex-matched healthy controls (to be recruited under another study with ethics approval obtained).
研究设计
- 研究类型
- 观察性研究
- 主要目的
- 析因分组（即根据危险因素或暴露因素分组）
- 盲法
- None
入排标准
- 年龄范围
- 18 至 100（—）
- 性别
- All
入选标准
- •Chinese people aged 18 or above, no upper age limit;
- •Having newly diagnosed malignant tumour;
- •A new case referred to the Oncology Centre for management.
排除标准
- •Patients who have previously received cancer therapy;
- •Patients who will receive concurrent radiotherapy;
- •Patients with conditions rendering them incapable to answer questionnaires or provide oral and stool samples;
- •Subjects who are unable to give consent.
研究组 & 干预措施
Group A
Chemotherapy
Group B
Immunotherapy
Group C
No anti-cancer therapy
结局指标
主要结局
Changes in gut and oral microbial community profiles measured by 16s and metagenomics sequencing before and after cancer therapy.
次要结局
- Correlation of gut and oral microbial community profiles measured by 16s and metagenomics sequencing with respect to tumour type and toxicity.
研究者
研究点 (1)
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