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Clinical Trials/NCT03488446
NCT03488446
Unknown
Not Applicable

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

Nanfang Hospital, Southern Medical University1 site in 1 country500 target enrollmentAugust 30, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Digestive System Diseases
Sponsor
Nanfang Hospital, Southern Medical University
Enrollment
500
Locations
1
Primary Endpoint
Pathological lymph node status of every station
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 30, 2017
End Date
March 31, 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Pathological lymph node status of every station

Time Frame: 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 Outcomes

  • Survival time(Follow-up from the date of surgery to the date of death.)
  • Lymph node stage (N stage)(Pathologic evaluation will be performed for each patient within 1 week after surgery)

Study Sites (1)

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