Clinical trial NCT06612216: Establishment of Cohort Under the Guidance of the Pathogenesis of Cancer Toxin in Traditional Chinese Medicine
Official 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Keywords: flora
microbiota
tumor
cancer toxin
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Dongzhimen Hospital, Beijing
name: Beijing Chest Hospital, Capital Medical University
name: Shanghai University of Traditional Chinese Medicine
name: Shaanxi Hospital of Traditional Chinese Medicine
name: Leling Traditional Chinese Medicine Hospital
name: Xinxiang medical university
First posted: 2024-09-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy individuals and cancer patients.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 16S rDNA
timeFrame: 2 years (from enrollment to disease progression).
Secondary outcomes:
measure: microbiota metagenomics
timeFrame: 2 years (from enrollment to disease progression).
measure: Untargeted metabolomics
timeFrame: 2 years (from enrollment to disease progression).
Other outcomes:
Locations:
Study officials:
References: