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The primary objective is to determine whether pretreatment-to-posttreatment changes in circulating multigene methylation levels correlate with objective response rates (ORR) assessed by contrast-enhanced CT/MRI and levels of serum tumor markers. Secondary endpoints include: (a) time-dependent association between methylation fluctuation patterns and progression-free survival (PFS), (b) comparative diagnostic accuracy of methylation indices versus conventional biomarkers, and (c) feasibility of using methylation thresholds to guide adaptive therapy modification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group one | Gastric cancer patients undergoing primary surgical treatment |
| |
| Group two | Gastric cancer patients undergoing surgery following neoadjuvant therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-gene methylation testing | Other | Undergo multi-gene methylation testing in blood during follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| Multi-gene methylation levels | Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively. | |
| Multi-gene methylation levels | Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.) | Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.) results will be extracted from historical medical records, with test dates typically ranging from baseline (within 3 months pre-enrollment) to follow-up intervals aligned with standard clinical practice (e.g., every 3-6 months post-treatment). These time points may not synchronize with the methylation assessment schedule. |
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Inclusion Criteria:
Age at initial diagnosis: 18-75 years Histologically confirmed gastric or gastroesophageal junction malignancy, with complete medical records, confirmed pathological diagnosis, and definitive staging data (TNM staging system) No history of other primary malignancies Absence of distant metastases (liver, lung, or other sites) confirmed by imaging examination (CT/MRI) No prior surgical resection, chemotherapy, or PD-1/PD-L1 immunotherapy before enrollment Availability of complete biospecimen information, including: Sample ID (medical record number), Demographic data (sex, age), Clinical diagnostic data, Tumor marker profiles (CEA, CA19-9, etc.)
Exclusion Criteria:
Life expectancy <6 months (as assessed by ECOG score ≥4 or Palliative Performance Scale ≤30%) Cognitive/psychiatric conditions: a. Legally incapacitated individuals without legal guardians, b. Active psychotic disorders (e.g., schizophrenia, bipolar disorder) or dementia (MMSE score <24) Investigator-determined exclusions
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Gastric cancer patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongyang Zhang | Contact | +86 188 3136 3219 | 18831363219@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital | Xi'an | Shaanxi | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Blood
| Multi-gene methylation testing | Other | Undergo multi-gene methylation testing in blood during follow-up |
|
| Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively. |
| Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.) | Imaging examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.) results will be collected from patient records. Imaging time points are determined by clinical needs (e.g., pre-treatment staging, 3-month post-treatment follow-up), with intervals independent of the methylation analysis schedule. The minimum interval between imaging and methylation sampling will be recorded. | Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively. |
| Endoscope | Endoscoping results will be collected from patient records. Imaging time points are determined by clinical needs (e.g., pre-treatment staging, 3-month post-treatment follow-up), with intervals independent of the methylation analysis schedule. The minimum interval between imaging and methylation sampling will be recorded. | Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively. |
| Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.) | Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.) results will be extracted from historical medical records, with test dates typically ranging from baseline (within 3 months pre-enrollment) to follow-up intervals aligned with standard clinical practice (e.g., every 3-6 months post-treatment). These time points may not synchronize with the methylation assessment schedule. | Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years |
| Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.) | Imaging examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.) results will be collected from patient records. Imaging time points are determined by clinical needs (e.g., pre-treatment staging, 3-month post-treatment follow-up), with intervals independent of the methylation analysis schedule. The minimum interval between imaging and methylation sampling will be recorded. | Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years |
| Endoscope | Endoscoping results will be collected from patient records. Imaging time points are determined by clinical needs (e.g., pre-treatment staging, 3-month post-treatment follow-up), with intervals independent of the methylation analysis schedule. The minimum interval between imaging and methylation sampling will be recorded. | Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years |
| Xijing Hospital | Xi'an | Shaanxi | China |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |