NCT06612216

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Sep 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Sep 2024Feb 2027

First Submitted

Initial submission to the registry

September 19, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

September 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

2.4 years

First QC Date

September 19, 2024

Last Update Submit

September 22, 2024

Conditions

Cancer

Keywords

floramicrobiotatumorcancer toxin

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years (from enrollment to disease progression).

Secondary Outcomes (2)

  • microbiota metagenomics

    2 years (from enrollment to disease progression).

  • Untargeted metabolomics

    2 years (from enrollment to disease progression).

Study Arms (6)

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.

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.

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.

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.

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.

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.

Other: No intervention was carried out

Interventions

No intervention was carried outOTHER

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

Patients with different symptom burdensPatients with different traditional Chinese medicine cancer toxicity syndrome typesPatients with different traditional Chinese medicine constitutionsPatients with different treatment and outcome outcomesPatients with different tumor burdenhealthy individuals and cancer patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy individuals and cancer patients.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood, feces, tissue, tongue coating

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Yi Xie, PhD

CONTACT

1881053759618810537596@163.com

Ying Zhang, PhD

CONTACT

13311027150zylzy501@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 25, 2024

Study Start

September 22, 2024

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share