Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer（RPLNM）(GIPMCS-1701)

• Conditions: Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Neoplasms; Digestive System Diseases

• Registration Number: NCT03488446
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Status Verified: 2017-08
• Study Start: 2017-08-30
• Study First Submitted: 2017-09-30
• Study First Submitted QC: 2018-03-28
• Last Update Submitted: 2018-03-28
• Study First Posted: 2018-04-05
• Last Update Posted: 2018-04-05
• Primary Completion: 2018-08-31
• Study Completion: 2019-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China