An observational study in Gastric Adenocarcinoma and Esophagogastric Junction Adenocarcinoma, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational
This multicenter retrospective observational cohort study will evaluate approximately 2,000 adults with gastric or esophagogastric junction adenocarcinoma who received at least two cycles of neoadjuvant therapy followed by R0 gastrectomy with lymph node dissection. The study will estimate the frequency of pathological metastasis at individual lymph node stations according to the final preoperative imaging-based ycT and ycN categories and tumor location. The findings are intended to provide evidence for future prospective studies of risk-adapted reduction of perigastric lymph node dissection. No treatment is assigned by this study.
This study will retrospectively collect de-identified clinical, imaging, operative, and pathological data from participating centers. Eligible operations will have been performed from January 1, 2021, through August 30, 2026. Neoadjuvant regimens may include chemotherapy, chemotherapy combined with immunotherapy, or chemoradiotherapy; patients treated with conversion therapy or intraperitoneal hyperthermic perfusion will not be included.
The last preoperative staging assessment must be completed within four weeks before surgery. The routine ycT and ycN categories will be determined by each center's multidisciplinary team, primarily using contrast-enhanced computed tomography and supplemented by endoscopy, endoscopic ultrasonography, or positron emission tomography-computed tomography when clinically indicated. De-identified final preoperative imaging will undergo independent blinded central review by two experienced gastric cancer radiologists, with discrepancies resolved by consensus. The central review ycT and ycN categories will be used for the primary analysis, and local multidisciplinary staging will be examined in sensitivity analyses. Staging will follow the eighth edition of the AJCC/UICC system. Only patients with ycM0 disease will be eligible.
Tumors will be classified into four mutually exclusive location cohorts. The E cohort includes tumors whose upper margin reaches or crosses the esophagogastric junction, or for which endoscopy explicitly reports an unclear, immediately adjacent, or involved dentate line. Other gastric tumors will be classified as U, M, or L according to the upper, middle, or lower third of the stomach under the Japanese Gastric Cancer Association anatomical system; tumors spanning more than one region will be assigned according to the location of the tumor center.
Station-specific pathological data will include No. 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 10, 11p, 11d, and 12a lymph nodes, with other para-aortic, abdominal, or mediastinal stations recorded separately. For each station, the denominator will include only patients in whom that station was actually dissected and had an evaluable station-specific pathological record. A station that was not dissected or could not be confirmed will be excluded from that station's denominator and will not be assumed to be pathologically negative.
Data will be entered into a standardized case report form, de-identified locally, and transferred to the coordinating center for centralized quality control and analysis. Additional participating centers may be added after registration. Station-specific metastasis proportions will be reported with Clopper-Pearson exact 95% confidence intervals. Group comparisons will use chi-square or Fisher exact tests as appropriate. Multilevel analyses will account for center effects, and exploratory comparisons across multiple nodal stations will use the Benjamini-Hochberg false discovery rate procedure. Firth penalized regression or exact estimates will be used for sparse outcomes; conventional multivariable models will be limited to outcomes with adequate event counts.
213 studies on the registry are indexed under Lymphatic Metastasis; 77 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 256 across 101 observational studies indexed under Lymphatic Metastasis.
Browse Lymphatic Metastasis studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.
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Adults treated at participating tertiary hospitals in China who underwent surgery from January 1, 2021, through August 30, 2026, for histologically confirmed gastric or esophagogastric junction adenocarcinoma after neoadjuvant therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with tumors whose upper margin reaches or crosses the esophagogastric junction, or whose endoscopy report explicitly describes an unclear, immediately adjacent, or involved dentate line.
Patients with non-E tumors centered in the upper third of the stomach according to the Japanese Gastric Cancer Association anatomical classification.
Patients with non-E tumors centered in the middle third of the stomach according to the Japanese Gastric Cancer Association anatomical classification.
Patients with non-E tumors centered in the lower third of the stomach according to the Japanese Gastric Cancer Association anatomical classification.
Station-specific lymph node metastasis rates stratified by ycT and ycN categories
For each E, U, M, and L tumor-location cohort and each prespecified lymph node station, the metastasis rate will be calculated as the number of patients with pathologically confirmed metastasis at that station divided by the number of patients in whom that station was actually dissected and had an evaluable station-specific pathological record. Rates will be reported across the complete AJCC/UICC eighth-edition ycT and ycN categories. Stations not dissected or not verifiably recorded will be excluded from the station-specific denominator and will not be classified as negative.
Time frame: At definitive postoperative pathological assessment, generally within 30 days after gastrectomy
Station-specific lymph node metastasis rates stratified by ypT, ypN, and tumor regression grade
Station-specific metastasis rates will be estimated according to postoperative ypT category, ypN category, and standardized tumor regression grade, using only patients with evaluable station-specific pathological records.
Time frame: At definitive postoperative pathological assessment, generally within 30 days after gastrectomy
Numbers of examined and metastatic lymph nodes according to tumor location
The total number of examined lymph nodes and the total number of pathologically metastatic lymph nodes will be summarized for the E, U, M, and L tumor-location cohorts and by gastrectomy type.
Time frame: At definitive postoperative pathological assessment, generally within 30 days after gastrectomy
Plan to share: No — Due to the ethic requirements of multicentered study.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University →