Gastric CancerNCT06232395
Early Detection and Post-operative Monitoring of Gastric Cancer
An observational study of Gastric Cancer, run by Suzhou Huhu Health & Technology Inc. at 2 sites in China.
Trial summary
This study is to determine the performance of non-invasive new multi-target biomarkers in the early detection and post-operative monitoring of gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- DNA test
- How many people
- 1,197 participants
- Where
- 2 sitesChina
- Study dates
- 18 Feb 2024to 17 Feb 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
- Healthy volunteers accepted
- 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 1197subjects 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center.
Shanghai, Shanghai Municipality, 200032
Dazhi Xu, MD., PhD,, +8613862036541, jiangnan@sz-hoho.com
Nan Jiang, +8615862461212, jn100@qq.com
- Recruiting
Fudan University Shanghai Cancer Center.
Shanghai, Shanghai Municipality, 200032
Dazhi Xu, MD., PhD, +8613862036541, jiangnan@sz-hoho.com
Nan Jiang, +8615862461212, jn100@qq.com
About this study
Official title: Early Detection and 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 early detection and post-operative monitoring of gastric cancer.
Read the detailed description
This study aims to develop and validate a new non-invasive detection method for early detection and postoperative monitoring of gastric cancer in the blood. Sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarkers in the diagnosis of gastric cancer will be compared with that of tumor biomarkers CA19-9, CEA, and CA72-4. Blood will also be collected at various time points post-operatively. The investigators will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. The investigators 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
circulating DNA test
| Study group | Role | What they receive |
|---|---|---|
| malignant group | Subjects diagnosed with gastric cancer. Receives: Diagnostic Test: DNA test | |
| non-malignant group | Healthy individuals and subjects with gastritis, gastric ulcer, gastric polyp or other benign gastric diseases. 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 detection system for gastric cancer (GC) detection
Evaluate sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarker for the diagnosis of gastric cancer.
Measured: 2 years
The performance of the new biomarkers in the post-operative monitoring of gastric cancer
Determine whether the new detection system can detect tumor recurrence and metastasis earlier than imaging and tumor marker CA19-9, CEA, and CA72-4.
Measured: 2 years
Secondary outcomes (2)
Compare the performance of the new biomarkers for GC detection with the conventional tumor markers
Determine whether the performance of the new biomarker detection system is better than that of tumor markers CA19-9, CEA, and CA72-4 in the diagnosis of gastric cancer.
Measured: 2 years
The performance of the new biomarkers as prognostic biomarkers
Determine whether the new biomarkers cancer serve as prognostic biomarkers to predict tumor recurrence and metastasis.
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 posted30 Jan 2024
- Study start18 Feb 2024
- Primary completion17 Feb 2026 (estimated)
- Study completion17 Feb 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
- 1,197 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Huhu Health & Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232395
- Sponsor's protocol ID
- 2311285-6
- Status last verified
- Jun 2025
- First submitted
- 17 Jan 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Post-operative Monitoring of Gastric Cancer Using Circulating DNA in Blood Samples
- ClinicalTrials.gov ID
- NCT06232395
- Acronym / sponsor ID
- 2311285-6
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,197 participants (estimated)
- Lead sponsor
- Suzhou Huhu Health & Technology Inc.Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 17 Feb 2026 (estimated)
- Study completion
- 17 Feb 2026 (estimated)
- First posted
- 30 Jan 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.
This study is to determine the performance of non-invasive new multi-target biomarkers in the early detection and post-operative monitoring of gastric cancer.
Detailed description
This study aims to develop and validate a new non-invasive detection method for early detection and postoperative monitoring of gastric cancer in the blood. Sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarkers in the diagnosis of gastric cancer will be compared with that of tumor biomarkers CA19-9, CEA, and CA72-4. Blood will also be collected at various time points post-operatively. The investigators will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. The investigators 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
- 2
| Arm | Type | Receives |
|---|---|---|
| malignant group | – | Diagnostic Test: DNA testSubjects diagnosed with gastric cancer. |
| non-malignant group | – | Diagnostic Test: DNA testHealthy individuals and subjects with gastritis, gastric ulcer, gastric polyp or other benign gastric diseases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- 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 1197subjects 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 testcirculating DNA test | Diagnostic test | malignant group, non-malignant group |
Primary outcome
The performance of the new detection system for gastric cancer (GC) detection
Time frame: 2 years
Evaluate sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarker for the diagnosis of gastric cancer.
The performance of the new biomarkers in the post-operative monitoring of gastric cancer
Time frame: 2 years
Determine whether the new detection system can detect tumor recurrence and metastasis earlier than imaging and tumor marker CA19-9, CEA, and CA72-4.
2 secondary outcomes
Compare the performance of the new biomarkers for GC detection with the conventional tumor markers
Time frame: 2 years
The performance of the new biomarkers as prognostic biomarkers
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 6 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
2 sites 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 2 sites 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 6 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 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance of the new detection system for gastric cancer (GC) detection (time frame: 2 years). 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 6 Jun 2025.