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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06612216
Enrollment
500
Registered
2024-09-25
Start date
2024-09-22
Completion date
2027-02-28
Last updated
2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

flora, microbiota, tumor, cancer toxin

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.

Interventions

This study observed differences in microbiota among different groups and therefore did not involve intervention.

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
CollaboratorOTHER
Dongzhimen Hospital, Beijing
CollaboratorOTHER
Beijing Chest Hospital, Capital Medical University
CollaboratorOTHER
Shanghai University of Traditional Chinese Medicine
CollaboratorOTHER
Shaanxi Hospital of Traditional Chinese Medicine
CollaboratorOTHER
Leling Traditional Chinese Medicine Hospital
CollaboratorUNKNOWN
Xinxiang medical university
CollaboratorOTHER
Ying Zhang
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
16S rDNA2 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

MeasureTime frameDescription
microbiota metagenomics2 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 metabolomics2 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.

Contacts

Primary ContactYi Xie, PhD
18810537596@163.com18810537596
Backup ContactYing Zhang, PhD
zylzy501@163.com13311027150

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026