- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03488446
Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer(RPLNM)(GIPMCS-1701)
March 28, 2018 updated by: Nanfang Hospital of Southern Medical University
This study proposes to establish a CT radiomics-based prediction model for identifying metastasis of each station lymph nodes in gastric cancer.
Study Overview
Status
Unknown
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 Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuming Jiang, M.D., Ph.D.
- Phone Number: +86-132-6826-6140
- Email: jiangymbest@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510-515
- Recruiting
- Nanfang Hospital, Southern Medical University
-
Contact:
- Yuming Jiang, M.D., Ph.D.
- Phone Number: +86-132-6826-6140
- Email: jiangymbest@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
pathologically proven gastric cancer patients who receive preoperative CT and surgical resection in these hospitals.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Pathologic evaluation will be performed for each patient within 1 week after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival time
Time Frame: Follow-up from the date of surgery to the date of death.
|
Disease-free survival and overall survival
|
Follow-up from the date of surgery to the date of death.
|
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)
|
Pathologic evaluation will be performed for each patient within 1 week after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Guoxin Li, M.D., PH.D., Nanfang Hospital of Southern Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Nat Commun. 2014;5:4644. Cavalho, Sara [corrected to Carvalho, Sara].
- 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.
- 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. Erratum In: J Clin Oncol. 2016 Jul 10;34(20):2436.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2017
Primary Completion (Anticipated)
August 31, 2018
Study Completion (Anticipated)
March 31, 2019
Study Registration Dates
First Submitted
September 30, 2017
First Submitted That Met QC Criteria
March 28, 2018
First Posted (Actual)
April 5, 2018
Study Record Updates
Last Update Posted (Actual)
April 5, 2018
Last Update Submitted That Met QC Criteria
March 28, 2018
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIPMCS-1701
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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