Screening and Validation of Serum Protein Biomarkers for Early Diagnosis of Gastric Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-95
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

History of prior malignancy or cancer treatment.

Presence of concurrent malignancies of other types.

Inability to tolerate gastroscopy.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,200 Participants
are grouped into 2 trial groups
Group A: Gastric cancer
Group B: Non Gastric Cancer

Trial outcomes

Primary outcomes

1

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.

Time frame
3 years

Secondary outcomes

1

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).

Time frame
3 years
2

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.

Time frame
3 years
3

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.

Time frame
3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: