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

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT06612216
• Lead Sponsor: Ying Zhang

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study Start: 2024-09-22
• Study First Submitted QC: 2024-09-22
• Last Update Submitted: 2024-09-22
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
16S rDNA	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.

Secondary Outcome Measures

Name	Time	Method
microbiota metagenomics	2 years (from enrollment to disease progression).	Metagenomic Sequencing is a technique that studies the total genetic material of all microorganisms in environmental samples. This method does not rely on traditional microbial isolation and cultivation, but instead directly extracts total DNA from environmental samples to obtain new functional genes and bioactive substances by constructing and screening metagenomic libraries.
Untargeted metabolomics	2 years (from enrollment to disease progression).	Untargeted Metabolomics is a research method that does not rely on prior knowledge of specific metabolites. Instead, it explores the overall patterns and changes of metabolites by analyzing all detectable metabolites in biological samples.