Gastric Cancer (Diagnosis)NCT07842549
Multicenter Study of Clinical-Pathological Correlation in cT2N0 Gastric Cancer and Its Prognostic Implications
An observational study of Gastric Cancer (Diagnosis) and TNM Staging, run by Hospital of Navarra at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer (Diagnosis), TNM Staging, Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer
- How many people
- 1,024 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2014to 1 Jun 2025
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- gastric adenocarcinoma, cT2N0 classification (CT scan/echoendoscopy), surgery with or without neoadjuvant therapy, pTNM stage recorded.
Who cannot join
- metastatic disease, non-curative resections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MULTICENTER STUDY OF CLINICAL-PATHOLOGICAL CORRELATION IN cT2N0 GASTRIC CANCER AND ITS PROGNOSTIC IMPLICATIONS
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.
Read the detailed description
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.
- Conditions
- Gastric Cancer (Diagnosis), TNM Staging, Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer, Gastric Surgery
- Keywords
- Gastric cancer, T2N0
- 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 |
|---|---|---|
| Patients with T2N0 gastric cancer | Gastric adenocarcinoma, cT2M0, surgery with or without neoadyuvant treatment, pTNM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 5 year
Secondary outcomes (9)
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
Measured: 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
Measured: through study completion, an average of 5 year
Understaging variables
To identify clinical, endoscopic, echoendoscopic, radiological, histological, and surgical variables associated with understaging
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Jan 2014
- Primary completion8 Jul 2016
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- 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
- Other
- Enrolment
- 1,024 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Hospital of Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Eguaras, Hospital of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842549
- Sponsor's protocol ID
- HUN
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available.
PubMed 32060757Levenson G, Voron T, Paye F, Balladur P, Debove C, Chafai N, De Dios AG, Lefevre JH, Parc Y. Tumor downstaging after neoadjuvant chemotherapy determines survival after surgery for gastric adenocarcinoma. Surgery. 2021 Dec;170(6):1711-1717. doi: 10.1016/j.surg.2021.08.021. Epub 2021 Sep 22.
PubMed 34561115Su P, Zhang Y, Yu T, Jiang L, Kang W, Liu Y, Yu J. Does postoperative chemotherapy improve overall survival of patients with ypT1-2N0 cancer? World J Surg Oncol. 2022 Dec 27;20(1):408. doi: 10.1186/s12957-022-02881-y.
PubMed 36572874Abboretti F, Lambert C, Schafer M, Pereira B, Le Roy B, Mege D, Piessen G, Gagniere J, Gronnier C, Mantziari S; ADENOKGAST Study Group; AFC-French Association of Surgery. Neoadjuvant Chemotherapy Does Not Improve Survival in cT2N0M0 Gastric Adenocarcinoma Patients: A Multicenter Propensity Score Analysis. Ann Surg Oncol. 2024 Aug;31(8):5273-5282. doi: 10.1245/s10434-024-15418-2. Epub 2024 May 18.
PubMed 38762640Baril JA, Ruedinger BM, Nguyen TK, Bilimoria KY, Ceppa EP, Maatman TK, Roch AM, Schmidt CM, Turk A, Yang AD, House MG, Ellis RJ. Staging accuracy in patients with clinical T2N0 gastric cancer: Implications for treatment sequencing. Surgery. 2025 Mar;179:108796. doi: 10.1016/j.surg.2024.07.055. Epub 2024 Oct 2.
PubMed 39358121Ju MR, Karalis JD, Blackwell JM, Mansour JC, Polanco PM, Augustine M, Yopp AC, Zeh HJ 3rd, Wang SC, Porembka MR. Inaccurate Clinical Stage Is Common for Gastric Adenocarcinoma and Is Associated with Undertreatment and Worse Outcomes. Ann Surg Oncol. 2021 May;28(5):2831-2843. doi: 10.1245/s10434-020-09403-8. Epub 2021 Jan 2.
PubMed 33389294Han C, Lin R, Shi H, Liu J, Qian W, Ding Z, Hou X. The role of endoscopic ultrasound on the preoperative T staging of gastric cancer: A retrospective study. Medicine (Baltimore). 2016 Sep;95(36):e4580. doi: 10.1097/MD.0000000000004580.
PubMed 27603347da Costa WL, Tran Cao HS, Gu X, Massarweh NN. Understanding the association between clinical staging accuracy, treatment response, and survival among gastric cancer patients through Bayesian analysis. J Surg Oncol. 2022 Nov;126(6):986-994. doi: 10.1002/jso.27016. Epub 2022 Jul 12.
PubMed 35819061Janczewski LM, Shah D, Wells A, Bentrem DJ, Abad JD, Chawla A. The inaccuracies of gastric adenocarcinoma clinical staging and its predictive factors. J Surg Oncol. 2023 Jun;127(7):1116-1124. doi: 10.1002/jso.27233. Epub 2023 Mar 11.
PubMed 36905333Obermannova RL, Leong T; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. ESMO Clinical Practice Guideline interim update on the treatment of locally advanced oesophageal and oesophagogastric junction adenocarcinoma and metastatic squamous-cell carcinoma. ESMO Open. 2025 Feb;10(2):104134. doi: 10.1016/j.esmoop.2025.104134. Epub 2025 Feb 12.
PubMed 39986705Lordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, Vogel A, Smyth EC; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct;33(10):1005-1020. doi: 10.1016/j.annonc.2022.07.004. Epub 2022 Jul 29. No abstract available.
PubMed 35914639Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.
PubMed 28094848World Health Organization. Global cancer observatory: Cancer today [Internet]. Lyon: International Agency for Research on Cancer; 2022 [cited 2026 Apr 9].
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTICENTER STUDY OF CLINICAL-PATHOLOGICAL CORRELATION IN cT2N0 GASTRIC CANCER AND ITS PROGNOSTIC IMPLICATIONS
- ClinicalTrials.gov ID
- NCT07842549
- Acronym / sponsor ID
- HUN
- Conditions
- Gastric Cancer (Diagnosis), TNM Staging, Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer, Gastric Surgery
- Keywords
- Gastric cancer, T2N0
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,024 participants (actual)
- Lead sponsor
- Hospital of NavarraUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 8 Jul 2016 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 25 Sep 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with T2N0 gastric cancer | – | –Gastric adenocarcinoma, cT2M0, surgery with or without neoadyuvant treatment, pTNM |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- gastric adenocarcinoma, cT2N0 classification (CT scan/echoendoscopy), surgery with or without neoadjuvant therapy, pTNM stage recorded.
Key exclusion criteria (1 listed)
- metastatic disease, non-curative resections.
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
Concordance between preoperative clinical staging and final pathological staging,
Time frame: through study completion, an average of 5 year
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.
9 secondary outcomes
Understaging adn overstaging rates
Time frame: through study completion, an average of 5 year
Accuracy of T and N
Time frame: through study completion, an average of 5 year
Understaging variables
Time frame: through study completion, an average of 5 years
Echoendoscopy role
Time frame: through study completion, an average of 5 years
Impact on survival
Time frame: through study completion, an average of 5 years
Appropriateness of treatment
Time frame: through study completion, an average of 5 years
Impact of under-staging
Time frame: through study completion, an average of 5 years
Relationship between downstaging and oncological outcomes
Time frame: through study completion, an average of 5 years
Predictive model
Time frame: through study completion, an average of 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 32060757Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available.
- Background: PubMed 34561115Levenson G, Voron T, Paye F, Balladur P, Debove C, Chafai N, De Dios AG, Lefevre JH, Parc Y. Tumor downstaging after neoadjuvant chemotherapy determines survival after surgery for gastric adenocarcinoma. Surgery. 2021 Dec;170(6):1711-1717. doi: 10.1016/j.surg.2021.08.021. Epub 2021 Sep 22.
- Background: PubMed 36572874Su P, Zhang Y, Yu T, Jiang L, Kang W, Liu Y, Yu J. Does postoperative chemotherapy improve overall survival of patients with ypT1-2N0 cancer? World J Surg Oncol. 2022 Dec 27;20(1):408. doi: 10.1186/s12957-022-02881-y.
- Background: PubMed 38762640Abboretti F, Lambert C, Schafer M, Pereira B, Le Roy B, Mege D, Piessen G, Gagniere J, Gronnier C, Mantziari S; ADENOKGAST Study Group; AFC-French Association of Surgery. Neoadjuvant Chemotherapy Does Not Improve Survival in cT2N0M0 Gastric Adenocarcinoma Patients: A Multicenter Propensity Score Analysis. Ann Surg Oncol. 2024 Aug;31(8):5273-5282. doi: 10.1245/s10434-024-15418-2. Epub 2024 May 18.
- Background: PubMed 39358121Baril JA, Ruedinger BM, Nguyen TK, Bilimoria KY, Ceppa EP, Maatman TK, Roch AM, Schmidt CM, Turk A, Yang AD, House MG, Ellis RJ. Staging accuracy in patients with clinical T2N0 gastric cancer: Implications for treatment sequencing. Surgery. 2025 Mar;179:108796. doi: 10.1016/j.surg.2024.07.055. Epub 2024 Oct 2.
- Background: PubMed 33389294Ju MR, Karalis JD, Blackwell JM, Mansour JC, Polanco PM, Augustine M, Yopp AC, Zeh HJ 3rd, Wang SC, Porembka MR. Inaccurate Clinical Stage Is Common for Gastric Adenocarcinoma and Is Associated with Undertreatment and Worse Outcomes. Ann Surg Oncol. 2021 May;28(5):2831-2843. doi: 10.1245/s10434-020-09403-8. Epub 2021 Jan 2.
- Background: PubMed 27603347Han C, Lin R, Shi H, Liu J, Qian W, Ding Z, Hou X. The role of endoscopic ultrasound on the preoperative T staging of gastric cancer: A retrospective study. Medicine (Baltimore). 2016 Sep;95(36):e4580. doi: 10.1097/MD.0000000000004580.
- Background: PubMed 35819061da Costa WL, Tran Cao HS, Gu X, Massarweh NN. Understanding the association between clinical staging accuracy, treatment response, and survival among gastric cancer patients through Bayesian analysis. J Surg Oncol. 2022 Nov;126(6):986-994. doi: 10.1002/jso.27016. Epub 2022 Jul 12.
- Background: PubMed 36905333Janczewski LM, Shah D, Wells A, Bentrem DJ, Abad JD, Chawla A. The inaccuracies of gastric adenocarcinoma clinical staging and its predictive factors. J Surg Oncol. 2023 Jun;127(7):1116-1124. doi: 10.1002/jso.27233. Epub 2023 Mar 11.
- Background: PubMed 39986705Obermannova RL, Leong T; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. ESMO Clinical Practice Guideline interim update on the treatment of locally advanced oesophageal and oesophagogastric junction adenocarcinoma and metastatic squamous-cell carcinoma. ESMO Open. 2025 Feb;10(2):104134. doi: 10.1016/j.esmoop.2025.104134. Epub 2025 Feb 12.
- Background: PubMed 35914639Lordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, Vogel A, Smyth EC; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct;33(10):1005-1020. doi: 10.1016/j.annonc.2022.07.004. Epub 2022 Jul 29. No abstract available.
- Background: PubMed 28094848Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.
- Individual participant dataSharing planned: 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
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer (Diagnosis) and TNM Staging, run by Hospital of Navarra at 1 site in Spain.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between preoperative clinical staging and final pathological staging, (time frame: through study completion, an average of 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07842549, which also lists 13 linked publications.
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 25 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.