Verifying the Specificity of a New Method in Predicting Lymph Node Metastasis in Early Gastric Cancer Patients
Verifying the Specificity of the Method Combining Nomogram and Sentinel Lymph Node in Predicting Lymph Node Metastasis in Early Gastric Cancer Patients: a Prospective, Single Arm, Observational Study
1 other identifier
observational
80
1 country
1
Brief Summary
Early gastric cancer is defined as gastric cancer that only invades mucosal or submucosal layer. The 5-year survival rate of gastric cancer can exceed 90% due to appropriate treatment. The most important consideration is whether there is lymph node metastasis. Preoperative examination including gastroscopy, endoscopic ultrasonography (EUS) and CT are not accurate enough to predict lymph node metastasis in early gastric cancer. In a retrospective study, we created a nomogram to predict lymph node metastasis in early gastric cancer. In prospective validation, the sensitivity and specificity of the nomogram was 75% and 91%, respectively. Sentinel lymph node is a promising concept in early gastric cancer. Using carbon nanoparticles as tracer, the sensitivity and specificity of sentinel lymph node predicting lymph node metastasis in early gastric cancer were 90% and 100%. Based on these results, we proposed a new method that combines the Nomogram and sentinel lymph node to predict lymph node metastasis in early gastric cancer. First, the probability of lymph node metastasis of early gastric cancer patients is calculated by the Nomogram. Those with low incidence of lymph node metastasis continue to the sentinel lymph node procedure. A patient will be considered non lymph node metastasis if his/her frozen pathology of the sentinel lymph nodes is negative during the surgery. Then the standard radical gastrectomy is performed with lymphadenectomy. By comparing postoperative pathology and sentinel lymph node frozen pathology, the specificity of Nomogram combining sentinel lymph node predicting lymph node metastasis in early gastric patients is calculated. The primary endpoint of this research is that the specificity of the above-mentioned method is over 95%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedAugust 15, 2018
August 1, 2018
2.3 years
August 13, 2018
August 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The specificity of the Nomogram combining sentinel lymph node in predicting lymph node metastasis in early gastric cancer patients
10 days after surgery when postoperative pathology result comes out
Secondary Outcomes (2)
The sensitivity of the Nomogram combining sentinel lymph node in predicting lymph node metastasis in early gastric cancer patients
10 days after surgery when postoperative pathology result comes out
The sensitivity of the Nomogram alone in predicting lymph node metastasis in early gastric cancer patients
10 days after surgery when postoperative pathology result comes out
Eligibility Criteria
Early gastric cancer patients with clinical stage T1N0M0
You may qualify if:
- diagnosed as gastric cancer by gastroscopy
- pathologically confirmed as adenocarcinoma
- ages between 18 and 80
- gastroscopy, abdominal enhanced CT and EUS completed
- clinical stage T1N0M0
- the score of the Nomogram less than 110
- potential resectable gastric cancer
- signed informed consent
You may not qualify if:
- absolute indication for endoscopic submucosal dissection (ESD)
- tumor located in esophagogastric junction (EGJ)
- accepted adjuvant therap
- pregnant or breast feeding
- history of upper abdominal surgery (laparoscopic cholecystectomy not included)
- history of gastric surgery
- emergency surgery such as perforation or obstruction
- other contraindication such as dysfunction of heart, lung, kidney
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhaode Bu, MDlead
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaode Bu, M.D.
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 13, 2018
First Posted
August 15, 2018
Study Start
September 1, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
August 15, 2018
Record last verified: 2018-08