Gastric CancerNCT05397444
Handgrip Strength (HGS) With HGS Asymmetry Are Associated With All-cause Mortality and Hospital Readmissions
An observational study of Gastric Cancer, run by Nanjing Medical University at 1 site in China.
Trial summary
Adding the handgrip strength (HGS) asymmetry to the existing measurements of low HGS may improve the assessment of muscle function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer
- How many people
- 342 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: elderly patients with gastric cancer
Who may be able to join
- with gastric cancer
- aged ≥60 years
- were scheduled to undergo radical surgery for the first time
Who cannot join
- received preoperative radiotherapy or chemotherapy
- combined with other types of malignant tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Handgrip Strength (HGS) With HGS Asymmetry is Associated With All-cause Mortality and Hospital Readmissions Among Elderly Patients With Gastric Cancer.
Adding the handgrip strength (HGS) asymmetry to the existing measurements of low HGS may improve the assessment of muscle function.
Read the detailed description
We sought to explore the associations between maximal HGS with HGS asymmetry and mortality, hospital readmissions, total complications, and prolonged length of stay (PLOS) among elderly patients with gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- No intervention
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Full robust | no low HGS without HGS asymmetry Receives: Other: No intervention | |
| low HGS alone | low HGS without HGS asymmetry Receives: Other: No intervention | |
| HGS asymmetry alone | no low HGS with HGS asymmetry Receives: Other: No intervention | |
| low HGS with HGS asymmetry | non Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
within 3 months after surgery, collected from telephone follow-up
Measured: about 3 months
Hospital readmissions
wihthin 3 months after surgery, collected from telephone follow-up
Measured: about 3 months
Secondary outcomes (2)
Total complications
during hospitalization, collected from medical records
Measured: about 3 months
prolonged length of stay
during hospitalization, collected from medical records
Measured: about 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 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.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 342 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
- Investigators
- xueyi miao, Principal investigator, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397444
- Sponsor's protocol ID
- HGS ASYMMETRY
- Status last verified
- May 2022
- First submitted
- 26 May 2022
- Last updated
- 31 May 2022
- 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 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handgrip Strength (HGS) With HGS Asymmetry is Associated With All-cause Mortality and Hospital Readmissions Among Elderly Patients With Gastric Cancer.
- ClinicalTrials.gov ID
- NCT05397444
- Acronym / sponsor ID
- HGS ASYMMETRY
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 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 May 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.
Adding the handgrip strength (HGS) asymmetry to the existing measurements of low HGS may improve the assessment of muscle function.
Detailed description
We sought to explore the associations between maximal HGS with HGS asymmetry and mortality, hospital readmissions, total complications, and prolonged length of stay (PLOS) among elderly patients with gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Full robust | – | Other: No interventionno low HGS without HGS asymmetry |
| low HGS alone | – | Other: No interventionlow HGS without HGS asymmetry |
| HGS asymmetry alone | – | Other: No interventionno low HGS with HGS asymmetry |
| low HGS with HGS asymmetry | – | Other: No interventionnon |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- elderly patients with gastric cancer
Key inclusion criteria (3 listed)
- with gastric cancer
- aged ≥60 years
- were scheduled to undergo radical surgery for the first time
Key exclusion criteria (2 listed)
- received preoperative radiotherapy or chemotherapy
- combined with other types 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 |
|---|---|---|
| No interventionThis is an observational study with no intervention. | Other | Full robust, HGS asymmetry alone, low HGS alone, low HGS with HGS asymmetry |
Primary outcome
All-cause mortality
Time frame: about 3 months
within 3 months after surgery, collected from telephone follow-up
Hospital readmissions
Time frame: about 3 months
wihthin 3 months after surgery, collected from telephone follow-up
2 secondary outcomes
Total complications
Time frame: about 3 months
prolonged length of stay
Time frame: about 3 months
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 31 May 2022.
- 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.
xueyi miao principal investigator
Nanjing Medical University
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 31 May 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?
All-cause mortality (time frame: about 3 months). The study lists 2 primary outcomes in all. 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 31 May 2022.