NCT03895008

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 8, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 5, 2019

Status Verified

March 1, 2019

Enrollment Period

4.5 years

First QC Date

March 28, 2019

Last Update Submit

July 2, 2019

Conditions

Keywords

Cardia gastric cancerNon-cardia gastric cancerResectionPrognosis

Outcome Measures

Primary Outcomes (1)

  • Disease Free Survival(DFS)

    The time from the primary operation to disease recurrence or death.

    5 years

Secondary Outcomes (1)

  • Overall survival(OS)

    5 years

Study Arms (2)

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.

Other: Cardia 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.

Other: Cardia and Non-cardia gastric cancer

Interventions

We classify gastric cancer into cardia gastric cancer and non-cardia gastric cancer.

Cardia gastric cancerNon-cardia gastric cancer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

gastric cancer

You may qualify if:

  • 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.

You may not qualify if:

  • Advanced gastric cancer patients with distant metastasis and inoperable ;
  • Pregnant or lactating women;
  • Patients who have no desire to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Second Hospital of Lanzhou University

Lanzhou, Gansu, China

RECRUITING

Affiliated Hospital of Qinghai University

Xining, Qinghai, 810000, China

RECRUITING

People's Hospital of Qinghai Province

Xining, Qinghai, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Jiuda Zhao, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2019

First Posted

March 29, 2019

Study Start

July 8, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

July 5, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations