Gastric Cancer (GC)SAHNCT07180966
Development and Validation of the Surgical Assessment and Healthcare (SAH) Index for Gastric Cancer Treatment Evaluation
An observational study of Gastric Cancer (GC), run by Ruijin Hospital at 1 site in China.
Trial summary
This study develops the Surgical Assessment and Healthcare (SAH) Index, a new tool to fairly evaluate gastric cancer surgery outcomes. Gastric cancer is a serious disease that often requires major surgery, but it can be difficult to compare how well different hospitals or surgeons perform because patients have… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer (GC)
- How many people
- 780 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2019to 28 Jul 2025
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients who underwent surgical resection for gastric adenocarcinoma in 2019. The cohort represents a real-world surgical population with complete clinical, pathological, and molecular characterization including TNM staging, Lauren classification, and biomarker status (HER2, MSI, MMR). Patients span all age groups, tumor stages, and surgical approaches, providing a representative sample for SAH Index development and validation. Long-term follow-up data available for survival and complication analysis. This describes your 780-patient cohort while staying under character limits and highlighting the comprehensive nature of your dataset.
Who may be able to join
- Age: 18 years and older Diagnosis: Histologically confirmed gastric adenocarcinoma Treatment: Underwent surgical resection in 2019 Data availability: Complete clinical, pathological, and molecular marker data Follow-up: Minimum 6 months post-operative follow-up data available
Who cannot join
- Histology: Non-adenocarcinoma gastric tumors Surgery type: Emergency surgery or palliative procedures only Data quality: Missing essential clinical, pathological, or molecular data required for SAH Index development Follow-up: Lost to follow-up within 30 days post-surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
This study develops the Surgical Assessment and Healthcare (SAH) Index, a new tool to fairly evaluate gastric cancer surgery outcomes. Gastric cancer is a serious disease that often requires major surgery, but it can be difficult to compare how well different hospitals or surgeons perform because patients have different levels of risk before surgery.
The SAH Index will help solve this problem by creating a standardized way to account for patient risk factors when evaluating surgical results. The study analyzes data from 780 patients who had gastric cancer surgery in 2019, looking at factors like patient age, tumor characteristics, molecular markers, and surgical outcomes.
Read more
By combining clinical information (like patient health), pathological details (like tumor type), and molecular features (like genetic markers), the SAH Index will create risk categories that allow fair comparison of surgical outcomes. This tool could help hospitals improve their care, help patients and families understand their treatment options, and help doctors make better treatment decisions.
The study uses only existing medical records and does not involve any new treatments or procedures. The goal is to create a practical tool that can be used by hospitals and doctors to better evaluate and improve gastric cancer surgery outcomes.
Read the detailed description
Gastric cancer remains a leading cause of cancer-related mortality worldwide, with significant variation in surgical outcomes across healthcare institutions. Current outcome reporting lacks adequate risk adjustment, making it difficult to distinguish between differences in patient populations versus actual care quality. This limitation hampers quality improvement efforts and evidence-based decision making.
This retrospective cohort study addresses this gap by developing the Surgical Assessment and Healthcare (SAH) Index, a comprehensive risk-adjustment tool specifically designed for gastric cancer surgery evaluation. The study leverages a unique dataset combining clinical, pathological, and molecular characteristics of 780 consecutive gastric cancer patients who underwent surgical resection in 2019.
The SAH Index development follows established risk prediction modeling methodology. Univariate analysis will identify potential predictors across four domains: clinical factors (demographics, comorbidities, performance status), surgical factors (procedure type, surgeon experience), pathological factors (tumor stage, grade, Lauren classification), and molecular factors (HER2, microsatellite instability, mismatch repair status, PD-L1 expression). Multivariable Cox regression and logistic regression models will be constructed for survival and morbidity outcomes, respectively.
Model development includes variable selection using backward elimination, assessment of multicollinearity, and evaluation of interaction terms. Internal validation will employ bootstrap resampling techniques to assess model stability and prevent overfitting. The final SAH Index will stratify patients into distinct risk categories with corresponding risk-adjusted outcome predictions.
Performance metrics include discrimination (C-statistic), calibration (Hosmer-Lemeshow test), and clinical utility assessment. The index will be validated against existing risk stratification tools and tested for its ability to detect outcome differences between healthcare providers after risk adjustment.
This study represents the first comprehensive attempt to create a gastric cancer-specific surgical risk index incorporating molecular biomarkers, addressing a critical need in surgical quality assessment and comparative effectiveness research.
- Conditions
- Gastric Cancer (GC)
- Keywords
- SAH Index; Risk adjustment; Gastric cancer surgery;, Prognostic model; Surgical outcomes;, Molecular biomarkers; HER2; Microsatellite instability; Mismatch repair;, Risk stratification; Quality assessment; Postoperative complications; Overall survival;, TNM staging; Lauren classification; Cox regression; Predictive modeling; Healthcare quality; Surgical evaluation; Risk prediction
- Medical subject headings
- Stomach Neoplasms, Microsatellite Instability, Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of SAH Index for Risk-Adjusted Gastric Cancer Surgical Evaluation
Development and internal validation of the Surgical Assessment and Healthcare (SAH) Index incorporating clinical, pathological, and molecular factors to predict surgical outcomes in gastric cancer patients. Performance assessed by discrimination (C-statistic), calibration (Hosmer-Lemeshow test), and risk stratification accuracy.
Measured: 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start2 Jan 2019
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BIRENDRA KUMAR SAH, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180966
- Sponsor's protocol ID
- SAH-INDEX
- Other IDs
- 2025-594
- Acronym
- SAH
- Status last verified
- May 2026
- First submitted
- 12 Sep 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared to protect patient privacy and comply with institutional data governance policies. The study involves retrospective analysis of clinical records containing sensitive medical information. De-identified aggregate results and statistical findings will be published to contribute to scientific knowledge while maintaining patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Surgical Assessment and Healthcare (SAH) Index for Gastric Cancer Treatment Evaluation
- ClinicalTrials.gov ID
- NCT07180966
- Acronym / sponsor ID
- SAH / SAH-INDEX
- Conditions
- Gastric Cancer (GC)
- Keywords
- SAH Index; Risk adjustment; Gastric cancer surgery;, Prognostic model; Surgical outcomes;, Molecular biomarkers; HER2; Microsatellite instability; Mismatch repair;, Risk stratification; Quality assessment; Postoperative complications; Overall survival;, TNM staging; Lauren classification; Cox regression; Predictive modeling; Healthcare quality; Surgical evaluation; Risk prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 18 Sep 2025 (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.
This study develops the Surgical Assessment and Healthcare (SAH) Index, a new tool to fairly evaluate gastric cancer surgery outcomes. Gastric cancer is a serious disease that often requires major surgery, but it can be difficult to compare how well different hospitals or surgeons perform because patients have different levels of risk before surgery.
The SAH Index will help solve this problem by creating a standardized way to account for patient risk factors when evaluating surgical results. The study analyzes data from 780 patients who had gastric cancer surgery in 2019, looking at factors like patient age, tumor characteristics, molecular markers, and surgical outcomes.
By combining clinical information (like patient health), pathological details (like tumor type), and molecular features (like genetic markers), the SAH Index will create risk categories that allow fair comparison of surgical outcomes. This tool could help hospitals improve their care, help patients and families understand their treatment options, and help doctors make better treatment decisions.
The study uses only existing medical records and does not involve any new treatments or procedures. The goal is to create a practical tool that can be used by hospitals and doctors to better evaluate and improve gastric cancer surgery outcomes.
Detailed description
Gastric cancer remains a leading cause of cancer-related mortality worldwide, with significant variation in surgical outcomes across healthcare institutions. Current outcome reporting lacks adequate risk adjustment, making it difficult to distinguish between differences in patient populations versus actual care quality. This limitation hampers quality improvement efforts and evidence-based decision making.
This retrospective cohort study addresses this gap by developing the Surgical Assessment and Healthcare (SAH) Index, a comprehensive risk-adjustment tool specifically designed for gastric cancer surgery evaluation. The study leverages a unique dataset combining clinical, pathological, and molecular characteristics of 780 consecutive gastric cancer patients who underwent surgical resection in 2019.
The SAH Index development follows established risk prediction modeling methodology. Univariate analysis will identify potential predictors across four domains: clinical factors (demographics, comorbidities, performance status), surgical factors (procedure type, surgeon experience), pathological factors (tumor stage, grade, Lauren classification), and molecular factors (HER2, microsatellite instability, mismatch repair status, PD-L1 expression). Multivariable Cox regression and logistic regression models will be constructed for survival and morbidity outcomes, respectively.
Model development includes variable selection using backward elimination, assessment of multicollinearity, and evaluation of interaction terms. Internal validation will employ bootstrap resampling techniques to assess model stability and prevent overfitting. The final SAH Index will stratify patients into distinct risk categories with corresponding risk-adjusted outcome predictions.
Performance metrics include discrimination (C-statistic), calibration (Hosmer-Lemeshow test), and clinical utility assessment. The index will be validated against existing risk stratification tools and tested for its ability to detect outcome differences between healthcare providers after risk adjustment.
This study represents the first comprehensive attempt to create a gastric cancer-specific surgical risk index incorporating molecular biomarkers, addressing a critical need in surgical quality assessment and comparative effectiveness research.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients who underwent surgical resection for gastric adenocarcinoma in 2019. The cohort represents a real-world surgical population with complete clinical, pathological, and molecular characterization including TNM staging, Lauren classification, and biomarker status (HER2, MSI, MMR). Patients span all age groups, tumor stages, and surgical approaches, providing a representative sample for SAH Index development and validation. Long-term follow-up data available for survival and complication analysis. This describes your 780-patient cohort while staying under character limits and highlighting the comprehensive nature of your dataset.
Key inclusion criteria (1 listed)
- Age: 18 years and older Diagnosis: Histologically confirmed gastric adenocarcinoma Treatment: Underwent surgical resection in 2019 Data availability: Complete clinical, pathological, and molecular marker data Follow-up: Minimum 6 months post-operative follow-up data available
Key exclusion criteria (1 listed)
- Histology: Non-adenocarcinoma gastric tumors Surgery type: Emergency surgery or palliative procedures only Data quality: Missing essential clinical, pathological, or molecular data required for SAH Index development Follow-up: Lost to follow-up within 30 days post-surgery
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
Development of SAH Index for Risk-Adjusted Gastric Cancer Surgical Evaluation
Time frame: 5 years post-surgery
Development and internal validation of the Surgical Assessment and Healthcare (SAH) Index incorporating clinical, pathological, and molecular factors to predict surgical outcomes in gastric cancer patients. Performance assessed by discrimination (C-statistic), calibration (Hosmer-Lemeshow test), and risk stratification accuracy.
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 26 May 2026.
- Individual participant dataSharing planned: No. Individual patient data will not be shared to protect patient privacy and comply with institutional data governance policies. The study involves retrospective analysis of clinical records containing sensitive medical information. De-identified aggregate results and statistical findings will be published to contribute to scientific knowledge while maintaining patient confidentiality.
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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 (GC), run by Ruijin Hospital at 1 site in China.
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 26 May 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 China. 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?
Development of SAH Index for Risk-Adjusted Gastric Cancer Surgical Evaluation (time frame: 5 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2026.