Establishment of Cohort Under the Guidance of the Pathogenesis of Cancer Toxin in Traditional Chinese Medicine
NCT ID: NCT06612216
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
500 participants
OBSERVATIONAL
2024-09-22
2027-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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healthy individuals and cancer patients
Comparing the microbiota characteristics of healthy individuals and cancer patients, revealing the differences in microbiota between healthy individuals and cancer patients.
No intervention was carried out
This study observed differences in microbiota among different groups and therefore did not involve intervention.
Patients with different traditional Chinese medicine cancer toxicity syndrome types
According to the classification of traditional Chinese medicine cancer toxin syndrome types, compare the differences in microbiota between the heat toxin syndrome group, dampness toxin syndrome group, stasis toxin syndrome group, phlegm toxin syndrome group, wind toxin syndrome group, and cold toxin syndrome group in cancer patients, and explore the influence of different cancer toxin syndrome types on microbiota composition.
No intervention was carried out
This study observed differences in microbiota among different groups and therefore did not involve intervention.
Patients with different traditional Chinese medicine constitutions
According to the traditional Chinese medicine constitution classification, compare the differences in microbiota among tumor patients with qi stagnation constitution group, phlegm dampness constitution group, damp heat constitution group, blood stasis constitution group, qi deficiency constitution group, yang deficiency constitution group, yin deficiency constitution group, characteristic constitution group, and peaceful constitution group, and explore the influence of different constitution types on the microbiota composition of tumor patients.
No intervention was carried out
This study observed differences in microbiota among different groups and therefore did not involve intervention.
Patients with different tumor burden
Divide tumor patients into tumor bearing group and tumor free group, and explore their microbiota characteristics and differential patterns.
No intervention was carried out
This study observed differences in microbiota among different groups and therefore did not involve intervention.
Patients with different symptom burdens
According to the MDASI Anderson Symptom Scale, compare the differences in microbiota between individuals with mild and severe symptom burdens, and explore the impact of different symptom burdens on the microbiota composition of cancer patients.
No intervention was carried out
This study observed differences in microbiota among different groups and therefore did not involve intervention.
Patients with different treatment and outcome outcomes
Based on the application of different treatment methods and the resulting outcomes in cancer patients, compare the characteristic differences of microbiota between groups and explore the differential expression of microbiota.
No intervention was carried out
This study observed differences in microbiota among different groups and therefore did not involve intervention.
Interventions
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No intervention was carried out
This study observed differences in microbiota among different groups and therefore did not involve intervention.
Eligibility Criteria
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Inclusion Criteria
* Informed consent and signed informed consent form.
* 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
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Xiyuan Hospital of China Academy of Chinese Medical Sciences
OTHER
Dongzhimen Hospital, Beijing
OTHER
Beijing Chest Hospital, Capital Medical University
OTHER
Shanghai University of Traditional Chinese Medicine
OTHER
Shaanxi Hospital of Traditional Chinese Medicine
OTHER
Leling Traditional Chinese Medicine Hospital
UNKNOWN
Xinxiang medical university
OTHER
Ying Zhang
OTHER
Responsible Party
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Ying Zhang
Director
Central Contacts
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Other Identifiers
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CI2023C025YL
Identifier Type: -
Identifier Source: org_study_id
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