Research on the Scientific Connotation of Cancer Toxin Pathogenesis Based on the Interaction Between Flora and Tumor-Establishment of Cohort Under the Guidance of the Pathogenesis of Cancer Toxin in Traditional Chinese Medicine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- 16S rDNA
研究概览
简要总结
The study aims to investigate the potential mechanisms by which the interaction between the microbiota and tumors leads to the occurrence and development of cancer by collecting clinical information and biological samples from healthy individuals and cancer patients.
详细描述
Study Design Types: A prospective, multicenter, observational study.
Observation Content:1.Healthy Individuals:General Information (Demographic Data), Traditional Chinese Medicine Physical Quality Scale, Biological Samples (Fecal, Blood, Tongue Coating, Tongue Appearance Photos, Tissues). 2.Malignant Tumor Patients: General Information (Demographic Data, Disease Information, ECOG Performance Status Score, MDASI Anderson Symptom Inventory), Traditional Chinese Medicine Cancer Toxin Syndrome Scale, Traditional Chinese Medicine Physical Quality Scale, Laboratory and Examination Data, Biological Samples (Fecal, Blood, Tongue Coating, Tongue Appearance Photos, Tissues).
Observation Time Points:1.Healthy Individuals: At the time of enrollment. 2.Malignant Tumor Patients: At the time of enrollment, 1 month after enrollment, every 3 months thereafter until tumor progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for healthy individuals:
- •Age ≥ 18 years old;
- •Informed consent and signed informed consent form.
- •Inclusion criteria for patients with malignant tumors:
- •Patients with malignant tumors diagnosed by pathology or cytology;
- •Advanced stage patients who have not received modern medical treatment in the past, or early to mid-stage patients who have completed postoperative radiochemotherapy for ≥ 1 month;
- •Age ≥ 18 years old;
- •Informed consent and signed informed consent form.
排除标准
- •Exclusion criteria for healthy individuals:
- •Patients with malignant tumors diagnosed by pathology or cytology;
- •Those who have taken any antibiotics/probiotics within 1 month before biological sample collection;
- •Those with other immune or infectious diseases;
- •Those with severe damage to the heart, liver, lungs, or kidney functions;
- •Pregnant women, or those with mental illnesses such as depression or schizophrenia;
- •Those deemed ineligible for the study by the researcher.
- •Exclusion criteria for patients with malignant tumors:
- •Patients with multiple primary cancers;
- •Those who have taken any antibiotics/probiotics within 1 month before biological sample collection;
- •Those with other immune or infectious diseases;
- •Those with severe damage to the heart, liver, lungs, or kidney functions;
- •Pregnant women, or those with mental illnesses such as depression or schizophrenia;
- •Those deemed ineligible for the study by the researcher.
结局指标
主要结局
16S rDNA
时间窗: 2 years (from enrollment to disease progression).
16S rDNA detection is a commonly used method in microbial molecular biology for identification and classification of bacteria. It can identify and classify bacteria.
次要结局
- microbiota metagenomics(2 years (from enrollment to disease progression).)
- Untargeted metabolomics(2 years (from enrollment to disease progression).)
研究者
Ying Zhang
Director
Guang'anmen Hospital of China Academy of Chinese Medical Sciences