- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03895008
Comparing the Prognosis of Patients With Cardia and Non-cardia Gastric Cancer.
July 2, 2019 updated by: Jiuda Zhao, Affiliated Hospital of Qinghai University
Comparing the Stage-for-Stage Prognosis of Patients With Cardia and Non-cardia Gastric Cancer After Operation.
To comparing the stage-for-stage prognosis of patients with cardia and non-cardia gastric cancer after operation.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to compare the stage-for-stage prognosis of patients with cardia and non-cardia gastric cancer after operation.In this study, patients with cardiac and non-cardiac gastric cancer who undergo radical resection from January 2019 to December 2024 will be included.
We will follow up the patient's progression, recurrence time and survival time.
Study Type
Observational
Enrollment (Anticipated)
1000
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: Jiuda Zhao, M.D.
- Phone Number: +869716162732
- Email: jiudazhao@126.com
Study Locations
-
-
Gansu
-
Lanzhou, Gansu, China
- Recruiting
- The Second Hospital of Lanzhou University
-
Contact:
- Enxi Li
- Phone Number: 15809317472
-
-
Qinghai
-
Xining, Qinghai, China, 810000
- Recruiting
- Affiliated Hospital of Qinghai University
-
Contact:
- Jiuda Zhao, M.D.
- Phone Number: +869716162732
- Email: jiudazhao@126.com
-
Xining, Qinghai, China
- Recruiting
- People's Hospital of Qinghai Province
-
Contact:
- Jie Kan, M.D
- Phone Number: +8613897584590
- Email: kanying1208@126.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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
gastric cancer
Description
Inclusion Criteria:
- Histopathology or cytopathology proven cardia or non-cardia gastric cancer;
- Operable gastric cancer patients: primary lesions can be completely excision, no distant metastasis;
- Life expectancy of at least 6 months;
- ECOG(Eastern Cooperative Oncology Group ) score 0-1;
- Age: 18~80 years old;
Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function).
For example: WBC(White blood cell count )>4.0×109/L; NEU(Neutrophils)>1.5×109/L; PLT(Platelet)>100×109/L;
- Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;
- Not concomitant with other uncontrollable benign diseases before the recruitment;
- Voluntarily signed the informed consent.
Exclusion Criteria:
- Advanced gastric cancer patients with distant metastasis and inoperable ;
- Pregnant or lactating women;
- Patients who have no desire to participate in the study.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cardia gastric cancer
Cardiac gastric cancer is defined as a cancer center lies arising 2-5 cm from the gastric mucosa distal to the esophagogastric junction.
|
We classify gastric cancer into cardia gastric cancer and non-cardia gastric cancer.
|
Non-cardia gastric cancer
Non-cardia gastric cancer is defined as tumors originated from the gastric mucosa distal to the cardia.
|
We classify gastric cancer into cardia gastric cancer and non-cardia gastric cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Free Survival(DFS)
Time Frame: 5 years
|
The time from the primary operation to disease recurrence or death.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival(OS)
Time Frame: 5 years
|
OS is defined as the time from the end of radical surgery to death for any reason or at the last follow-up.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
July 8, 2019
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
March 28, 2019
First Submitted That Met QC Criteria
March 28, 2019
First Posted (Actual)
March 29, 2019
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 2, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHQU-2019001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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