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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03488446
Recruitment Status : Unknown
Verified August 2017 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Study Description
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Brief Summary:
This study proposes to establish a CT radiomics-based prediction model for identifying metastasis of each station lymph nodes in gastric cancer.

Condition or disease
Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Gastrointestinal Diseases Stomach Neoplasms

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 Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer（RPLNM）(GIPMCS-1701)
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Survival time [ Time Frame: Follow-up from the date of surgery to the date of death. ]
    Disease-free survival and overall survival

  2. Lymph node stage (N stage) [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pathologically proven gastric cancer patients who receive preoperative CT and surgical resection in these hospitals.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488446


Contacts
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Contact: Guoxin Li, M.D., PH.D. +86-138-0277-1450 gzliguoxin@163.com
Contact: Yuming Jiang, M.D., PH.D. +86-132-6826-6140 jiangymbest@163.com

Locations
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China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510-515
Contact: Guoxin Li, M.D., Ph.D.    +86-138-0277-1450    gzliguoxin@163.com   
Contact: Yuming Jiang, M.D., Ph.D.    +86-132-6826-6140    jiangymbest@163.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
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
Investigators
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Principal Investigator: Guoxin Li, M.D., PH.D. Nanfang Hospital of Southern Medical University
More Information
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Publications of Results:

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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03488446    
Other Study ID Numbers: GIPMCS-1701
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanfang Hospital of Southern Medical University:
Gastric Cancer
Radiomics
Computed Tomograpy
Lymph Node Metastasis
Prediction
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Stomach Neoplasms
Lymphatic Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Gastrointestinal Diseases
Digestive System Diseases
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Stomach Diseases