Gastric CancerNCT03895008
Comparing the Prognosis of Patients With Cardia and Non-cardia Gastric Cancer.
An observational study of Gastric Cancer, run by Affiliated Hospital of Qinghai University at 3 sites in China.
Trial summary
To comparing the stage-for-stage prognosis of patients with cardia and non-cardia gastric cancer after operation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Cardia and Non-cardia gastric cancer
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- 8 Jul 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: gastric cancer
Who may be able to join
- 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).
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- 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.
Who cannot join
- Advanced gastric cancer patients with distant metastasis and inoperable ;
- Pregnant or lactating women;
- Patients who have no desire to participate in the study.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
The Second Hospital of Lanzhou University
Lanzhou, Gansu
Enxi Li, 15809317472
- Recruiting
Affiliated Hospital of Qinghai University
Xining, Qinghai, 810000
Jiuda Zhao, M.D., +869716162732, jiudazhao@126.com
- Recruiting
People's Hospital of Qinghai Province
Xining, Qinghai
Jie Kan, M.D, +8613897584590, kanying1208@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- Cardia and Non-cardia gastric cancer
- Keywords
- Cardia gastric cancer, Non-cardia gastric cancer, Resection, Prognosis
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardia and Non-cardia gastric cancerOther
We classify gastric cancer into cardia gastric cancer and non-cardia gastric cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Cardia and Non-cardia gastric cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival（DFS）
The time from the primary operation to disease recurrence or death.
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start8 Jul 2019 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Qinghai University
- Sponsor type
- University, hospital or other
- Collaborators
- Qinghai People's Hospital, LanZhou University
- Responsible party
- Principal investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895008
- Sponsor's protocol ID
- AHQU-2019001
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Stage-for-Stage Prognosis of Patients With Cardia and Non-cardia Gastric Cancer After Operation.
- ClinicalTrials.gov ID
- NCT03895008
- Acronym / sponsor ID
- AHQU-2019001
- Conditions
- Gastric Cancer
- Keywords
- Cardia gastric cancer, Non-cardia gastric cancer, Resection, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Qinghai UniversityUniversity, hospital or other
- Collaborators
- Qinghai People's Hospital, LanZhou University
- Study start
- 8 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To comparing the stage-for-stage prognosis of patients with cardia and non-cardia gastric cancer after operation.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardia gastric cancer | – | Other: Cardia and Non-cardia gastric cancerCardiac gastric cancer is defined as a cancer center lies arising 2-5 cm from the gastric mucosa distal to the esophagogastric junction. |
| Non-cardia gastric cancer | – | Other: Cardia and Non-cardia gastric cancerNon-cardia gastric cancer is defined as tumors originated from the gastric mucosa distal to the cardia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- gastric cancer
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (3 listed)
- Advanced gastric cancer patients with distant metastasis and inoperable ;
- Pregnant or lactating women;
- Patients who have no desire to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardia and Non-cardia gastric cancerWe classify gastric cancer into cardia gastric cancer and non-cardia gastric cancer. | Other | Cardia gastric cancer, Non-cardia gastric cancer |
Primary outcome
Disease Free Survival（DFS）
Time frame: 5 years
The time from the primary operation to disease recurrence or death.
1 secondary outcome
Overall survival(OS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Affiliated Hospital of Qinghai University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiuda Zhao, M.D. (+869716162732, jiudazhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival（DFS） (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.