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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03895008
Other study ID # AHQU-2019001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 8, 2019
Est. completion date December 31, 2024

Study information

Verified date March 2019
Source Affiliated Hospital of Qinghai University
Contact Jiuda Zhao, M.D.
Phone +869716162732
Email jiudazhao@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To comparing the stage-for-stage prognosis of patients with cardia and non-cardia gastric cancer after operation.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Histopathology or cytopathology proven cardia or non-cardia gastric cancer;

2. Operable gastric cancer patients: primary lesions can be completely excision, no distant metastasis;

3. Life expectancy of at least 6 months;

4. ECOG(Eastern Cooperative Oncology Group ) score 0-1;

5. Age: 18~80 years old;

6. 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;

7. Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;

8. Not concomitant with other uncontrollable benign diseases before the recruitment;

9. Voluntarily signed the informed consent.

Exclusion Criteria:

1. Advanced gastric cancer patients with distant metastasis and inoperable ;

2. Pregnant or lactating women;

3. Patients who have no desire to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cardia and Non-cardia gastric cancer
We classify gastric cancer into cardia gastric cancer and non-cardia gastric cancer.

Locations

Country Name City State
China The Second Hospital of Lanzhou University Lanzhou Gansu
China Affiliated Hospital of Qinghai University Xining Qinghai
China People's Hospital of Qinghai Province Xining Qinghai

Sponsors (3)

Lead Sponsor Collaborator
Affiliated Hospital of Qinghai University LanZhou University, Qinghai People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease Free Survival(DFS) The time from the primary operation to disease recurrence or death. 5 years
Secondary Overall survival(OS) 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
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