Gastric CancerNCT07026240
Post-operative Monitoring of Gastric Cancer
An observational study of Gastric Cancer, run by Suzhou Huhu Health & Technology Inc. at 1 site in China.
Trial summary
This study is to determine the performance of non-invasive new multi-target biomarkers in the post-operative monitoring of gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- DNA test
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2024to 7 Jan 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects age over 18, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. More than 258 subjects are targeted to enroll.
Who may be able to join
- Subject age over 18.
- Subject has stomach discomfort, and seek medical attention at the Gastric Surgery Department of our center.
- Subject has or will have gastroscopy and/or pathological examination results at this center.
- Subject must be able to fully understand the informed consent form and be able to personally sign it.
Who cannot join
- Subject has serious heart, liver, kidney dysfunction, or mental illness.
- Subject diagnosed previously with any kind of malignant tumor.
- Subject is known to be infected with HIV or other related diseases (considering interference from the use of immune drugs).
- Subject is receiving targeted drugs, immunosuppressants, immunomodulators, and biological therapies.
- Researchers believe that subject is not suitable for enrollment.
- Subject can not supply sufficient sample to complete this experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dazhi Xu, MD., PhD, +8615862461212, jiangnan@sz-hoho.com
About this study
Official title: Post-operative Monitoring of Gastric Cancer Using Circulating DNA in Blood Samples
This study is to determine the performance of non-invasive new multi-target biomarkers in the post-operative monitoring of gastric cancer.
Read the detailed description
This study aims to develop and validate a new non-invasive detection method for postoperative monitoring of gastric cancer in the blood. Blood will also be collected at various time points post-operatively. We will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. We will also determine whether these new biomarkers detect tumor recurrence and metastasis earlier than methods currently used in the clinic such as imaging and tumor biomarkers CA19-9, CEA, and CA72-4.
This study is a prospective and multi-center study.
- Conditions
- Gastric Cancer
- Being tested
- DNA test
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA testDiagnostic test
a new non-invasive detection method for postoperative monitoring of gastric cancer in the blood
| Study group | Role | What they receive |
|---|---|---|
| malignant group | Subjects diagnosed with gastric cancer. Receives: Diagnostic Test: DNA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The performance of the new biomarkers in the post-operative monitoring of gastric cancer
Number of Participants With Tumor Recurrence Detected by the New System vs. Imaging and Serum Markers (CA19-9, CEA, CA72-4).
Measured: 2 years
Secondary outcomes (1)
Metastasis Detection Time: New vs. Conventional Methods
Time to Detection of Metastasis (Days) by the New System Compared to Conventional Methods.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start18 Feb 2024
- Primary completion7 Jan 2026 (estimated)
- Study completion7 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Huhu Health & Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Dazhi Xu, MD., PhD,, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026240
- Sponsor's protocol ID
- 2311285-6（1）
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Monitoring of Gastric Cancer Using Circulating DNA in Blood Samples
- ClinicalTrials.gov ID
- NCT07026240
- Acronym / sponsor ID
- 2311285-6（1）
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Suzhou Huhu Health & Technology Inc.Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 7 Jan 2026 (estimated)
- Study completion
- 7 Jan 2026 (estimated)
- First posted
- 18 Jun 2025 (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 study is to determine the performance of non-invasive new multi-target biomarkers in the post-operative monitoring of gastric cancer.
Detailed description
This study aims to develop and validate a new non-invasive detection method for postoperative monitoring of gastric cancer in the blood. Blood will also be collected at various time points post-operatively. We will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. We will also determine whether these new biomarkers detect tumor recurrence and metastasis earlier than methods currently used in the clinic such as imaging and tumor biomarkers CA19-9, CEA, and CA72-4.
This study is a prospective and multi-center study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| malignant group | – | Diagnostic Test: DNA testSubjects diagnosed with gastric cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects age over 18, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. More than 258 subjects are targeted to enroll.
Key inclusion criteria (4 listed)
- Subject age over 18.
- Subject has stomach discomfort, and seek medical attention at the Gastric Surgery Department of our center.
- Subject has or will have gastroscopy and/or pathological examination results at this center.
- Subject must be able to fully understand the informed consent form and be able to personally sign it.
Key exclusion criteria (6 listed)
- Subject has serious heart, liver, kidney dysfunction, or mental illness.
- Subject diagnosed previously with any kind of malignant tumor.
- Subject is known to be infected with HIV or other related diseases (considering interference from the use of immune drugs).
- Subject is receiving targeted drugs, immunosuppressants, immunomodulators, and biological therapies.
- Researchers believe that subject is not suitable for enrollment.
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 |
|---|---|---|
| DNA testa new non-invasive detection method for postoperative monitoring of gastric cancer in the blood | Diagnostic test | malignant group |
Primary outcome
The performance of the new biomarkers in the post-operative monitoring of gastric cancer
Time frame: 2 years
Number of Participants With Tumor Recurrence Detected by the New System vs. Imaging and Serum Markers (CA19-9, CEA, CA72-4).
1 secondary outcome
Metastasis Detection Time: New vs. Conventional Methods
Time frame: 2 years
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 18 Jun 2025.
- 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.
Dazhi Xu, MD., PhD, principal investigator
Fudan University
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 Gastric Cancer, run by Suzhou Huhu Health & Technology Inc. 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 6 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: looking for participants now, as of the sponsor's last update on 18 Jun 2025. 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?
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 Dazhi Xu, MD., PhD, (+86 13862036541, jiangnan@sz-hoho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance of the new biomarkers in the post-operative monitoring of gastric cancer (time frame: 2 years). 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 18 Jun 2025.