Validating a risk scoring model for lymph node metastasis in gastric cancer patients
A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for Lymph Node Metastasis in Gastric Cancer Patients
This study is testing a scoring system to see if it can accurately predict lymph node spread in gastric cancer patients after they have surgery to remove their stomach.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT06339307 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a previously established risk scoring model that predicts lymph node metastasis in patients undergoing radical gastrectomy for gastric cancer. It is a single-centre, prospective observational study where data will be collected to assess the accuracy of the model in predicting patient outcomes related to lymph node metastasis after curative surgery. The study will compare observed outcomes with the predictions made by the risk scoring model to evaluate its clinical applicability and validity.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with primary gastric adenocarcinoma who are scheduled for curative surgery with R0 resection.
Not a fit: Patients with autoimmune diseases, concurrent cancers, or those who have undergone recent chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve preoperative risk assessment for gastric cancer patients, leading to better treatment planning and outcomes.
How similar studies have performed: Other studies have shown success in validating predictive models for cancer outcomes, suggesting that this approach has potential for meaningful contributions to clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Primary gastric adenocarcinoma; 2. Curative surgery (with R0 resection, excluding palliative surgery and cases with distant metastasis). Exclusion Criteria: 1. Patients with autoimmune diseases, inflammation, or hematological disorders; 2. Patients with a history of or concurrent other cancers; 3. Presence of active infection and inflammation (based on WBC count, patients with count of 10×10\^9 or higher should be evaluated through medical record examination for the presence of infection); 4. Active bleeding (as determined by endoscopic ultrasound and HGB ≤ 90); 5. Post neoadjuvant radiotherapy or chemotherapy; 6. History of blood transfusion, corticosteroid use, or leukocyte-stimulating medications within the past month prior to blood draw; 7. Incomplete clinical and pathological data.
Where this trial is running
Tianjin, Tianjin
- Cancer Hospital of Tianjin Medical University — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Jingyu Deng, M.D.
- Email: dengery@126.com
- Phone: +86-22-23340123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.