Malignant Tumors of Digestive TractNCT05794841
Multi-omics Study of Tongue Coating in Malignant Tumors of Digestive Tract
An observational study of Malignant Tumors of Digestive Tract, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This is a prospective, multi-center, observational cohort study and seeks to enroll 20000 patients with one malignant tumor of digestive tract or healthy individual. This study collected tongue coating samples non-invasively and analyzed the tongue coating metaproteomics, metagenomics and metabolomics profiles of… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Tumors of Digestive Tract
- What is being tested?
- Tongue coating sample collection and multi-omics analysis
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Histologically or cytologically confirmed digestive tract malignant tumor，and no prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor.
Who may be able to join
- 18≤age≤80.
- Histologically or cytologically confirmed malignant tumor.
- No prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor.
- Subject volunteers to join the study, signs informed consent, has good compliance and can cooperate with follow-up.
Who cannot join
- Two or more kinds of malignant tumors at the same time.
- Malignant tumor that has been treated by chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor therapy.
- Subjects who had other factors that might force them to terminate the research ahead of time, such as the development of other severe disease (including mental disease) that required combined treatment, seriously abnormal laboratory examination value, and family or social factors that might affect the subject safety or experimental data collection, as judged by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, 310000
Xiangdong Cheng, PhD., +0086-0571-88128041, chengxd516@126.com
About this study
Official title: Tongue Coating Multi-omics Detection for Distinguishing Patients With Gastrointestinal Malignancies From Healthy Individuals
This is a prospective, multi-center, observational cohort study and seeks to enroll 20000 patients with one malignant tumor of digestive tract or healthy individual.
This study collected tongue coating samples non-invasively and analyzed the tongue coating metaproteomics, metagenomics and metabolomics profiles of patients with gastrointestinal malignancies.
The performance characteristics(sensitivity and specificity) of tongue coating morphology, metaproteomics, metagenomics and metabolomics tests for detection of gastrointestinal malignancies are evaluated in comparison to pathology.
- Conditions
- Malignant Tumors of Digestive Tract
- Being tested
- Tongue coating sample collection and multi-omics analysis
- Keywords
- Tongue coating, Digestive tract, Malignant tumors, Multi-omics analysis
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue coating sample collection and multi-omics analysisDiagnostic test
Tongue coating sample collection and multi-omics analysis for building a diagnostic model
| Study group | Role | What they receive |
|---|---|---|
| Patients with digestive tract malignant tumors | Patients with malignant tumors of the esophagus, stomach or colon confirmed by pathology, have not received anti-tumor therapy, and have not had malignant tumors in the past. Receives: Diagnostic Test: Tongue coating sample collection and multi-omics analysis | |
| Healthy volunteer | Healthy individuals with no digestive tract malignancies confirmed by gastroscopy and colonoscopy. Receives: Diagnostic Test: Tongue coating sample collection and multi-omics analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of sensitivity, specificity
Using pathological diagnosis as the gold standard
Measured: 1 year
Diagnostic performance of positive predictive value (PPV) and negative predictive value (NPV).
Using pathological diagnosis as the gold standard
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Tumors of Digestive TractStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Liaoning Cancer Hospital & Institute, RenJi Hospital, Fujian Cancer Hospital, Sun Yat-sen University, The Second Affiliated Hospital of Harbin Medical University, Sichuan Cancer Hospital and Research Institute, Zhejiang Provincial Tongde Hospital, Yuhang District Hospital of Traditional Chinese Medicine, The First People's Hospital of Yuhang District, The First Affiliated Hospital of Anhui University of Chinese Medicine, BGI-Shenzhen, Shangyu People's Hospital, Xianju People's Hospital, Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
- Investigators
- Xiangdong Cheng, PhD., Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794841
- Sponsor's protocol ID
- IRB-2023-100
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue Coating Multi-omics Detection for Distinguishing Patients With Gastrointestinal Malignancies From Healthy Individuals
- ClinicalTrials.gov ID
- NCT05794841
- Acronym / sponsor ID
- IRB-2023-100
- Conditions
- Malignant Tumors of Digestive Tract
- Keywords
- Tongue coating, Digestive tract, Malignant tumors, Multi-omics analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Liaoning Cancer Hospital & Institute, RenJi Hospital, Fujian Cancer Hospital, Sun Yat-sen University, The Second Affiliated Hospital of Harbin Medical University, Sichuan Cancer Hospital and Research Institute, Zhejiang Provincial Tongde Hospital, Yuhang District Hospital of Traditional Chinese Medicine, The First People's Hospital of Yuhang District, The First Affiliated Hospital of Anhui University of Chinese Medicine, BGI-Shenzhen, Shangyu People's Hospital, Xianju People's Hospital, Shanghai Zhongshan Hospital
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 3 Apr 2023 (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.
This is a prospective, multi-center, observational cohort study and seeks to enroll 20000 patients with one malignant tumor of digestive tract or healthy individual.
This study collected tongue coating samples non-invasively and analyzed the tongue coating metaproteomics, metagenomics and metabolomics profiles of patients with gastrointestinal malignancies.
The performance characteristics(sensitivity and specificity) of tongue coating morphology, metaproteomics, metagenomics and metabolomics tests for detection of gastrointestinal malignancies are evaluated in comparison to pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with digestive tract malignant tumors | – | Diagnostic Test: Tongue coating sample collection and multi-omics analysisPatients with malignant tumors of the esophagus, stomach or colon confirmed by pathology, have not received anti-tumor therapy, and have not had malignant tumors in the past. |
| Healthy volunteer | – | Diagnostic Test: Tongue coating sample collection and multi-omics analysisHealthy individuals with no digestive tract malignancies confirmed by gastroscopy and colonoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically or cytologically confirmed digestive tract malignant tumor，and no prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor.
Key inclusion criteria (4 listed)
- 18≤age≤80.
- Histologically or cytologically confirmed malignant tumor.
- No prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor.
- Subject volunteers to join the study, signs informed consent, has good compliance and can cooperate with follow-up.
Key exclusion criteria (3 listed)
- Two or more kinds of malignant tumors at the same time.
- Malignant tumor that has been treated by chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor therapy.
- Subjects who had other factors that might force them to terminate the research ahead of time, such as the development of other severe disease (including mental disease) that required combined treatment, seriously abnormal laboratory examination value, and family or social factors that might affect the subject safety or experimental data collection, as judged by the researchers.
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 |
|---|---|---|
| Tongue coating sample collection and multi-omics analysisTongue coating sample collection and multi-omics analysis for building a diagnostic model | Diagnostic test | Healthy volunteer, Patients with digestive tract malignant tumors |
Primary outcome
Diagnostic performance of sensitivity, specificity
Time frame: 1 year
Using pathological diagnosis as the gold standard
Diagnostic performance of positive predictive value (PPV) and negative predictive value (NPV).
Time frame: 1 year
Using pathological diagnosis as the gold standard
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
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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. This study is not recruiting at the moment.
Xiangdong Cheng, PhD. principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumors of Digestive Tract, run by Zhejiang Cancer Hospital at 1 site in China.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangdong Cheng, PhD. (0086-571-88128041, chengxd516@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of sensitivity, specificity (time frame: 1 year). The study lists 2 primary outcomes in all. 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 3 Apr 2023.