Gastric Cancer (Diagnosis)NCT07096752
Screening and Validation of Serum Protein Biomarkers for Early Diagnosis of Gastric Cancer
An observational study of Gastric Cancer (Diagnosis), run by Shanghai Zhongshan Hospital.
Trial summary
This study focuses on the discovery of protein biomarkers for the early diagnosis of gastric cancer and the development of corresponding detection methods. By employing advanced mass spectrometry-based proteomic technologies, the investigators conducted an in-depth analysis of a large cohort of clinical samples to… Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer (Diagnosis)
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Jun 2029
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study recruits two main populations: patients with gastric cancer and non-gastric cancer participants. The latter group includes two subgroups: individuals with precancerous gastric lesions and healthy controls.
Who may be able to join
- Gastric cancer patients enrolled in this study must meet all of the following criteria:
- Male or female, aged ≥18 and ≤95 years.
- Histopathologically confirmed gastric cancer, as defined by the 2024 edition of the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Gastric Cancer.
- No prior anti-tumor treatment (including radiotherapy, chemotherapy, targeted therapy, or immunotherapy).
- Availability of complete clinicopathological data and follow-up information.
- Patients with precancerous gastric lesions must meet all of the following criteria:
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- Male or female, aged ≥18 and ≤95 years.
- Histopathologically confirmed absence of gastric cancer.
- Diagnosis consistent with precancerous gastric lesions as defined by the American Society for Gastrointestinal Endoscopy (ASGE, 2015 edition).
- Availability of complete clinicopathological data and follow-up information.
- Healthy controls must meet all of the following criteria:
- Male or female, aged ≥18 and ≤95 years.
- Histopathologically confirmed absence of gastric cancer.
- No evidence of precancerous gastric lesions.
- Availability of complete clinicopathological data and follow-up information.
Who cannot join
- Patients meeting any of the following conditions will be excluded:
- History of prior malignancy or cancer treatment.
- Presence of concurrent malignancies of other types.
- Inability to tolerate gastroscopy.
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
This study focuses on the discovery of protein biomarkers for the early diagnosis of gastric cancer and the development of corresponding detection methods. By employing advanced mass spectrometry-based proteomic technologies, the investigators conducted an in-depth analysis of a large cohort of clinical samples to identify specific protein biomarkers capable of accurately distinguishing gastric cancer patients from healthy individuals. The findings from this research are expected to facilitate the development of novel non-invasive or minimally invasive diagnostic approaches, thereby improving early detection, enhancing patient prognosis, and increasing survival rates.
- Conditions
- Gastric Cancer (Diagnosis)
- Medical subject headings
- Stomach Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer | Patients with histopathologically confirmed gastric cancer | |
| Non Gastric Cancer | Healthy controls or patients with histologically confirmed precancerous gastric lesions that have not yet progressed to malignancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance of the Serum Protein Biomarker-Based Model for Gastric Cancer
Evaluation of the sensitivity and specificity of a diagnostic model constructed using key serum protein biomarkers for the early detection of gastric cancer.
Measured: 3 years
Secondary outcomes (3)
Predictive performance of the serum protein model for the progression risk from precancerous gastric lesions to gastric cancer
Predictive performance of the serum protein model for the progression risk from precancerous gastric lesions to gastric cancer, evaluated by prediction accuracy and area under the ROC curve (AUC).
Measured: 3 years
Predictive performance of the serum protein model for response to neoadjuvant therapy in gastric cancer
Predictive performance of the serum protein model for response to neoadjuvant therapy in gastric cancer, assessed by prediction accuracy and AUC.
Measured: 3 years
Prognostic performance of the serum protein model in gastric cancer patients
Prognostic performance of the serum protein model in gastric cancer patients, measured by prediction accuracy and AUC.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (Diagnosis)Studies 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao-Jie Li, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096752
- Sponsor's protocol ID
- B2025-308R
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 31 Jul 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Validation of Serum Protein Biomarkers for Early Diagnosis of Gastric Cancer
- ClinicalTrials.gov ID
- NCT07096752
- Acronym / sponsor ID
- B2025-308R
- Conditions
- Gastric Cancer (Diagnosis)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 31 Jul 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 focuses on the discovery of protein biomarkers for the early diagnosis of gastric cancer and the development of corresponding detection methods. By employing advanced mass spectrometry-based proteomic technologies, the investigators conducted an in-depth analysis of a large cohort of clinical samples to identify specific protein biomarkers capable of accurately distinguishing gastric cancer patients from healthy individuals. The findings from this research are expected to facilitate the development of novel non-invasive or minimally invasive diagnostic approaches, thereby improving early detection, enhancing patient prognosis, and increasing survival rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer | – | –Patients with histopathologically confirmed gastric cancer |
| Non Gastric Cancer | – | –Healthy controls or patients with histologically confirmed precancerous gastric lesions that have not yet progressed to malignancy. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study recruits two main populations: patients with gastric cancer and non-gastric cancer participants. The latter group includes two subgroups: individuals with precancerous gastric lesions and healthy controls.
Key inclusion criteria (15 listed)
- Male or female, aged ≥18 and ≤95 years.
- Histopathologically confirmed gastric cancer, as defined by the 2024 edition of the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Gastric Cancer.
- No prior anti-tumor treatment (including radiotherapy, chemotherapy, targeted therapy, or immunotherapy).
- Availability of complete clinicopathological data and follow-up information.
- Male or female, aged ≥18 and ≤95 years.
Key exclusion criteria (4 listed)
- History of prior malignancy or cancer treatment.
- Presence of concurrent malignancies of other types.
- Inability to tolerate gastroscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Performance of the Serum Protein Biomarker-Based Model for Gastric Cancer
Time frame: 3 years
Evaluation of the sensitivity and specificity of a diagnostic model constructed using key serum protein biomarkers for the early detection of gastric cancer.
3 secondary outcomes
Predictive performance of the serum protein model for the progression risk from precancerous gastric lesions to gastric cancer
Time frame: 3 years
Predictive performance of the serum protein model for response to neoadjuvant therapy in gastric cancer
Time frame: 3 years
Prognostic performance of the serum protein model in gastric cancer patients
Time frame: 3 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 31 Jul 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer (Diagnosis), run by Shanghai Zhongshan Hospital.
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 15 inclusion and 4 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 31 Jul 2025. 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 Zhaoqing Tang (+86 64041990, tang.zhaoqing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of the Serum Protein Biomarker-Based Model for Gastric Cancer (time frame: 3 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 31 Jul 2025.