Establishment of Cohort Under the Guidance of the Pathogenesis of Cancer Toxin in Traditional Chinese Medicine

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое No intervention was carried out
  This study observed differences in microbiota among different groups and therefore did not involve intervention.

Первичные конечные точки

• 16S rDNA [Срок оценки: 2 years (from enrollment to disease progression).]

Вторичные конечные точки (2)

• microbiota metagenomics [Срок оценки: 2 years (from enrollment to disease progression).]
• Untargeted metabolomics [Срок оценки: 2 years (from enrollment to disease progression).]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06612216 · CI2023C025YL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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