Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06612216

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention was carried out

Other

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

Primary outcomes

  1. 16S rDNA

    Time frame: 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 outcomes

  1. microbiota metagenomics

    Time frame: 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.

  2. Untargeted metabolomics

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Xie, PhD

CONTACT

[email protected]

18810537596

Ying Zhang, PhD

CONTACT

[email protected]

13311027150

Sponsors and collaborators

Lead sponsor

Ying Zhang

Other

Collaborators

  • Beijing Chest Hospital, Capital Medical University
  • Dongzhimen Hospital, Beijing
  • Henan Medical University
  • Leling Traditional Chinese Medicine Hospital
  • Shaanxi Hospital of Traditional Chinese Medicine
  • Shanghai University of Traditional Chinese Medicine
  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.