CancerNCT06612216
Establishment of Cohort Under the Guidance of the Pathogenesis of Cancer Toxin in Traditional Chinese Medicine
An observational study of Cancer, run by Ying Zhang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2024to 28 Feb 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Healthy individuals and cancer patients.
Who may be able to join
- Age ≥ 18 years old;
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- No intervention was carried out
- Keywords
- flora, microbiota, tumor, cancer toxin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was carried outOther
This study observed differences in microbiota among different groups and therefore did not involve intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention was carried out | |
| 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. Receives: Other: No intervention was carried out | |
| 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. Receives: Other: No intervention was carried out | |
| Patients with different tumor burden | Divide tumor patients into tumor bearing group and tumor free group, and explore their microbiota characteristics and differential patterns. Receives: Other: No intervention was carried out | |
| 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. Receives: Other: No intervention was carried out | |
| 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. Receives: Other: No intervention was carried out |
What is being measured
The primary outcome is the main question the study is designed to answer.
16S rDNA
16S rDNA detection is a commonly used method in microbial molecular biology for identification and classification of bacteria. It can identify and classify bacteria.
Measured: 2 years (from enrollment to disease progression).
Secondary outcomes (2)
microbiota metagenomics
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.
Measured: 2 years (from enrollment to disease progression).
Untargeted metabolomics
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.
Measured: 2 years (from enrollment to disease progression).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start22 Sep 2024 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ying Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, Dongzhimen Hospital, Beijing, Beijing Chest Hospital, Capital Medical University, Shanghai University of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine, Leling Traditional Chinese Medicine Hospital, Henan Medical University
- Responsible party
- Sponsor-investigator, Ying Zhang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612216
- Sponsor's protocol ID
- CI2023C025YL
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06612216
- Acronym / sponsor ID
- CI2023C025YL
- Conditions
- Cancer
- Keywords
- flora, microbiota, tumor, cancer toxin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ying ZhangUniversity, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, Dongzhimen Hospital, Beijing, Beijing Chest Hospital, Capital Medical University, Shanghai University of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine, Leling Traditional Chinese Medicine Hospital, Henan Medical University
- Study start
- 22 Sep 2024 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| healthy individuals and cancer patients | – | Other: No intervention was carried outComparing the microbiota characteristics of healthy individuals and cancer patients, revealing the differences in microbiota between healthy individuals and cancer patients. |
| Patients with different traditional Chinese medicine cancer toxicity syndrome types | – | Other: No intervention was carried outAccording 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. |
| Patients with different traditional Chinese medicine constitutions | – | Other: No intervention was carried outAccording 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. |
| Patients with different tumor burden | – | Other: No intervention was carried outDivide tumor patients into tumor bearing group and tumor free group, and explore their microbiota characteristics and differential patterns. |
| Patients with different symptom burdens | – | Other: No intervention was carried outAccording 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. |
| Patients with different treatment and outcome outcomes | – | Other: No intervention was carried outBased 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals and cancer patients.
Key inclusion criteria (6 listed)
- Age ≥ 18 years old;
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention was carried outThis study observed differences in microbiota among different groups and therefore did not involve intervention. | Other | Patients with different symptom burdens, Patients with different traditional Chinese medicine cancer toxicity syndrome types, Patients with different traditional Chinese medicine constitutions, Patients with different treatment and outcome outcomes, Patients with different tumor burden, healthy individuals and cancer patients |
Primary outcome
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.
2 secondary outcomes
microbiota metagenomics
Time frame: 2 years (from enrollment to disease progression).
Untargeted metabolomics
Time frame: 2 years (from enrollment to disease progression).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Ying Zhang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Xie, PhD (18810537596, 18810537596@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16S rDNA (time frame: 2 years (from enrollment to disease progression).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.