Clinical trial NCT03488446: Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer（RPLNM）(GIPMCS-1701)
Official title: Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer（RPLNM）(GIPMCS-1701)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Stomach Neoplasms
Keywords: Gastric Cancer
Radiomics
Computed Tomograpy
Lymph Node Metastasis
Prediction
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Sun Yat-sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: The Third Affiliated Hospital of Southern Medical University
First posted: 2018-04-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pathologically proven gastric cancer patients who receive preoperative CT and surgical resection in these hospitals.

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.

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.

Primary outcomes:
measure: Pathological lymph node status of every station
timeFrame: Pathologic evaluation will be performed for each patient within 1 week after surgery
Secondary outcomes:
measure: Survival time
timeFrame: Follow-up from the date of surgery to the date of death.
measure: Lymph node stage (N stage)
timeFrame: Pathologic evaluation will be performed for each patient within 1 week after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Guoxin Li, M.D., PH.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gillies RJ, Kinahan PE, Hricak H. Radiomics: Images Are More than Pictures, They Are Data. Radiology. 2016 Feb;278(2):563-77. doi: 10.1148/radiol.2015151169. Epub 2015 Nov 18.
citation: Aerts HJ, Velazquez ER, Leijenaar RT, Parmar C, Grossmann P, Carvalho S, Bussink J, Monshouwer R, Haibe-Kains B, Rietveld D, Hoebers F, Rietbergen MM, Leemans CR, Dekker A, Quackenbush J, Gillies RJ, Lambin P. Decoding tumour phenotype by noninvasive imaging using a quantitative radiomics approach. Nat Commun. 2014 Jun 3;5:4006. doi: 10.1038/ncomms5006.
citation: Huang YQ, Liang CH, He L, Tian J, Liang CS, Chen X, Ma ZL, Liu ZY. Development and Validation of a Radiomics Nomogram for Preoperative Prediction of Lymph Node Metastasis in Colorectal Cancer. J Clin Oncol. 2016 Jun 20;34(18):2157-64. doi: 10.1200/JCO.2015.65.9128. Epub 2016 May 2.