Digestive System Diseases, Digestive System Neoplasms, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Stomach Neoplasms
Conditions
Keywords
Gastric Cancer, Radiomics, Computed Tomograpy, Lymph Node Metastasis, Prediction
Brief summary
This study proposes to establish a CT radiomics-based prediction model for identifying metastasis of each station lymph nodes in gastric cancer.
Detailed description
This is a prospective, multi-center trial conducted at 4 high-volume gastric cancer centers in China (Nanfang Hospital of Southern Medical University; Sun Yat-Sen University Cancer Center; First Affiliated Hospital, Sun Yat-Sen University; The Third Affiliated Hospital, Sun Yat-Sen University) designed to determine the predicted performance of radiomics-based prediction model for identifying metastasis of each station lymph nodes by enhanced CT for preoperative noninvasive assessment of the lymph node status in patients with gastric cancer. The study includes the construction of CT radiomics-based prediction model and the validation of the prediction model.
Interventions
None listed
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
Third Affiliated Hospital, Sun Yat-Sen University
The Third Affiliated Hospital of Southern Medical University
Nanfang Hospital, Southern Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years; * Patients providing written informed consent; * Pathologically proven gastric cancer scheduled to preoperative enhanced abdomen CT and undergo gastrectomy with type D2 lymphadenectomy; * Has undergone \> 64 multi-detector row CT within 14 days prior to surgical resection; .No receipt of preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy).
Exclusion criteria
* Preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy); * Failed to receive preoperative enhanced abdomen CT or undergo gastrectomy with type D2 lymphadenectomy; * Inavailable pathological results for local lymph node status; * Inquality of CT images for feature extraction; .Patient quit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological lymph node status of every station | Pathologic evaluation will be performed for each patient within 1 week after surgery | Pathological lymph node status of each station is defined as lymph node metastasis exist or not |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival time | Follow-up from the date of surgery to the date of death. | Disease-free survival and overall survival |
| Lymph node stage (N stage) | Pathologic evaluation will be performed for each patient within 1 week after surgery | Pathological lymph node stage after surgery (N0 stage: no lymph node metastassis; N1 stage: 1-2 lymph node metastasis; N2 stage: 3-6 lymph node metastasis; N3a stage: 7-15 lymph node metastasis;N3b stage: \>15 lymph node metastassis) |
Countries
China
Contacts
Primary ContactGuoxin Li, M.D., PH.D.
Backup ContactYuming Jiang, M.D., PH.D.
Outcome results
None listed