Gastric CancerNCT05301699
Development and Validation of a Web-based Nomorgam to Predict Postoperative Complications
An observational study of Gastric Cancer, run by Nanjing Medical University at 1 site in China.
Trial summary
The incidence of complications after gastrectomy remains high among elderly patients with gastric cancer. The investigators sought to establish and validate a web-based nomorgam for predicting total complications among elderly patients undergoing resection of gastric cancer. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- data analysis; validating the nomogram
- How many people
- 582 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 30 Mar 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: elderly gastric cancer patients
Who may be able to join
- diagnosed with gastric cancer by endoscopy or pathology
- planned to receive radical surgery for the first time
- aged 60 or older
Who cannot join
- received preoperative radiotherapy or chemotherapy
- with other sites of malignant tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Web-based Nomorgam to Predict Postoperative Complications After Radical Gastrectomy Among Elderly Gastric Cancer Patients
The incidence of complications after gastrectomy remains high among elderly patients with gastric cancer. The investigators sought to establish and validate a web-based nomorgam for predicting total complications among elderly patients undergoing resection of gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- data analysis; validating the nomogram
- Keywords
- gastric cancer;postoperative complications;nomogram
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data analysis; validating the nomogramOther
Not Applicable. Our study did not involve intervention
| Study group | Role | What they receive |
|---|---|---|
| training cohort | The training cohort was used for data analysis. Receives: Other: data analysis; validating the nomogram | |
| validation cohort | The validation cohort was used for validating the nomogram Receives: Other: data analysis; validating the nomogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications during hospitalization
the investigators captured it from electronic medical records
Measured: about 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Mar 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
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
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xueyi Miao, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301699
- Sponsor's protocol ID
- XMiao
- Status last verified
- May 2022
- First submitted
- 19 Mar 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Web-based Nomorgam to Predict Postoperative Complications After Radical Gastrectomy Among Elderly Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT05301699
- Acronym / sponsor ID
- XMiao
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer;postoperative complications;nomogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 31 Mar 2022 (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.
The incidence of complications after gastrectomy remains high among elderly patients with gastric cancer. The investigators sought to establish and validate a web-based nomorgam for predicting total complications among elderly patients undergoing resection of gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training cohort | – | Other: data analysis; validating the nomogramThe training cohort was used for data analysis. |
| validation cohort | – | Other: data analysis; validating the nomogramThe validation cohort was used for validating the nomogram |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elderly gastric cancer patients
Key inclusion criteria (3 listed)
- diagnosed with gastric cancer by endoscopy or pathology
- planned to receive radical surgery for the first time
- aged 60 or older
Key exclusion criteria (2 listed)
- received preoperative radiotherapy or chemotherapy
- with other sites of malignant tumors
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 |
|---|---|---|
| data analysis; validating the nomogramNot Applicable. Our study did not involve intervention | Other | training cohort, validation cohort |
Primary outcome
postoperative complications during hospitalization
Time frame: about 3 weeks
the investigators captured it from electronic medical records
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Nanjing Medical University at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications during hospitalization (time frame: about 3 weeks). 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 1 Jun 2022.