An observational study in Gastric Cancer (Diagnosis), TNM Staging and Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer, sponsored by Hospital of Navarra. Completed at 1 site in Spain. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Hospital of Navarra · Observational
Among 173 studies in Stomach Neoplasms with a site in Spain — 37 open to participants now, 63 under way, 12 of them phase 3. Stomach Neoplasms · Spain.
Among the 173 studies in Stomach Neoplasms with a site in Spain, this one is the 6th largest by enrollment of the 25 observational ones, is one of 5 that started in 2014, is one of 25 observational ones, and was the 172nd registered.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's enrollment of 1,024 is above the median of 278 across 790 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →37 of the 173 studies in Stomach Neoplasms with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 702 Stomach Neoplasms studies recruiting now, 375 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 68 take healthy volunteers.
This study: male · healthy volunteers too.
The full table on the hub →173 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 5 started in 2014.
Median enrollment 174 across the 148 interventional studies, 505 across the 25 observational. Of the 97 that completed or were terminated, 44 (45%) have results posted.
132 of 173 have an industry lead sponsor. The 10 most frequent:
Hospital of Navarra is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Hospital of Navarra has 2 studies filed under Stomach Neoplasms — fewer than ten, so there is no comparison to draw.
19 of the studies in Stomach Neoplasms with a site in Spain that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01924819Phase 3Australasian Gastro-Intestinal Trials GroupTrial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma | 2026-12-31 |
| NCT06532006Phase 3Shanghai Henlius BiotechA Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer | 2027-06-01 |
| NCT06219941AstraZenecaAZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 | 2026-11-17 |
| NCT05789069HiFiBiO TherapeuticsA Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors | 2026-12 |
| NCT05238883HiFiBiO TherapeuticsA Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors | 2026-12 |
Among the 173 studies in Stomach Neoplasms with a site in Spain, from their registry updates:
In gastric cancer, accurate preoperative staging of patients with T2N0 disease remains challenging. Correct assessment of tumor depth and lymph node involvement is particularly important in this subgroup, as treatment strategies may differ depending on the final stage. This study aims to correlate preoperative diagnostic findings with postoperative histopathological results in patients with suspected T2N0 gastric cancer, in order to assess the accuracy of current staging modalities and identify factors that may improve preoperative staging and guide treatment selection.
Gastric cancer remains one of the leading causes of cancer-related mortality worldwide, ranking fifth in incidence and fourth as a cause of cancer-related death, according to the latest data from the World Health Organization (WHO). Currently, treatment selection for resectable disease is based on the clinical TNM classification according to the 8th edition of the American Joint Committee on Cancer (AJCC), which allows for differentiation between early-stage tumors eligible for resection as the first (primary) treatment and locally advanced disease, in which perioperative treatment has been shown to improve survival.
However, there is a subgroup of patients for whom this approach has significant limitations: those diagnosed with cT2N0 gastric cancer.
The cT2N0 stage represents a transition point between early-stage and locally advanced disease, where the indication for primary surgery or perioperative treatment is controversial. Population-based studies have shown that the concordance between clinical and pathological staging in gastric cancer is suboptimal, with error rates approaching 40%.
This phenomenon is particularly pronounced in the cT2N0 subgroup, where agreement can drop as low as 34.7%, making it the group with the poorest diagnostic accuracy.
In this context, endoscopic ultrasound (EUS) has traditionally been considered the most accurate tool for preoperative locoregional staging of gastric cancer, especially in the assessment of tumor depth (T). EUS allows for detailed visualization of the different layers of the gastric wall, making it the gold standard for assessing tumor invasion. However, current evidence shows more heterogeneous results than previously assumed, with an overall accuracy for T staging of approximately 64.2% .
Importantly, the accuracy of EUS is particularly limited in intermediate stages such as T2, where discrimination between invasion of the muscularis propria and the subserosa can be technically complex, and where published rates of understaging (≈22.9%) and overstaging (≈12.9%) have been reported [7].
Furthermore, in addition to the limitation in diagnostic accuracy for "T" staging, the understaging rate is elevated due to the presence of undetected lymph node in the preoperative diagnosis. The sensitivity of imaging techniques for lymph node detection falls within suboptimal ranges (≈45-60%), with occult lymph node involvement accounting for more than 70% of cases of understaging.
Consequently, approximately half of the patients classified as cT2N0 are ultimately restaged to more advanced stages following surgical resection.
Paradoxically, the available evidence also suggests that not all patients with cT2N0 benefit from more intensive strategies. In a multicenter European cohort, neoadjuvant chemotherapy was not associated with improved survival compared with primary surgery. Furthermore, the benefit of postoperative treatment depends on the initial clinical stage. However, the ESMO guidelines for the treatment of gastric cancer propose neoadjuvant therapy for cT2N0 disease in their management algorithm. Tumor downstaging following neoadjuvant therapy is associated with improved survival, although the ability to select appropriate candidates preoperatively remains limited.
Finally, regarding the management of this cT2N0 group, the available scientific evidence comes primarily from U.S. and Asian cohorts, with limited European studies. No European esophagogastric cancer population registry has provided evidence in this field.
Consequently, cT2N0 gastric cancer represents a critical knowledge gap.
Clinical factors: age, sex, ASA status, Charlson score, frailty (Veljanovich Modified Frailty Index), tumor markers (CEA, CA 19.9).
Preoperative diagnosis: CT scan, endoscopic ultrasound, endoscopic findings, biopsy (Lauren classification, histological grade).
Surgical and pathological: type of gastrectomy, lymphadenectomy, pTNM, number of lymph nodes examined, resected, and involved Prognosis: neoadjuvant therapy, ypTNM, recurrence, overall survival, and disease-free survival.
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.
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.
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.
Gastric adenocarcinoma, cT2M0, surgery with or without neoadyuvant treatment, pTNM
Concordance between preoperative clinical staging and final pathological staging,
To evaluate, in a national multicenter cohort of patients with gastric cancer clinically classified as T2N0, the frequency and determinants of discordance between preoperative clinical staging and final pathological staging, with particular emphasis on understaging of the T component and, above all, the N component, as well as its impact on the appropriateness of the initial treatment strategy.
Time frame: through study completion, an average of 5 year
Understaging adn overstaging rates
To quantify the overall clinical-pathological concordance rate in cT2N0 patients and to describe the rates of understaging and overstaging separately
Time frame: through study completion, an average of 5 year
Accuracy of T and N
To analyze the diagnostic accuracy of T- and N-component staging in the cT2N0 subgroup
Time frame: through study completion, an average of 5 year
Understaging variables
To identify clinical, endoscopic, echoendoscopic, radiological, histological, and surgical variables associated with understaging
Time frame: through study completion, an average of 5 years
Echoendoscopy role
To evaluate the role of echoendoscopy and other staging tools in real-world clinical practice
Time frame: through study completion, an average of 5 years
Impact on survival
To compare initial surgery with a multimodal strategy, analyzing postoperative staging (including downstaging) and its impact on survival.
Time frame: through study completion, an average of 5 years
Appropriateness of treatment
Assess the appropriateness of treatment based on the final disease stage or estimated risk.
Time frame: through study completion, an average of 5 years
Impact of under-staging
To analyze the impact of under-staging in T and N on overall survival, disease-free survival, and recurrence patterns.
Time frame: through study completion, an average of 5 years
Relationship between downstaging and oncological outcomes
To explore the relationship between downstaging and oncological outcomes in patients treated with neoadjuvant therapy
Time frame: through study completion, an average of 5 years
Predictive model
Develop a predictive model for under-staging risk that can be applied in clinical practice
Time frame: through study completion, an average of 5 years
Plan to share: Undecided — Individual participant data will not be shared publicily because the dtaset cotains potentially identifiable patient information and is subject to applicable data protection and ethical regulations. Aggregated study results may be shared through scientific publications and presentations
Ran from Jan 2014 to primary completion in Jul 2016, 30 months.
Of 322 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 171. This study's 30 months is below that.
Counting every sponsor, half of 364 studies reached it within 54 months; a quarter within 29 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
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 completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Hospital of Navarra