Gastric (Stomach) CancerNCT06763068
Skeletal Muscle Mass Used to Assess Frailty in Older Gastric Cancer Patients
An observational study of Gastric (Stomach) Cancer and Frailty, run by Nanjing Medical University at 1 site in China.
Trial summary
The primary aim of this study was to quantify the diagnosis of pre-surgical skeletal muscle mass in elderly gastric cancer patients and to analyse its correlation with frailty. The second aim was to investigate whether skeletal muscle mass, or sarcopenia, is associated with mobility and nutritional status, and anxiety… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Gastric (Stomach) Cancer, Frailty, Sarcopenia
- What is being tested?
- Skeletal muscle mass and frailty
- How many people
- 575 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Dec 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: Convenience sampling method was used to select older people with gastric cancer who attended a tertiary care hospital in China from March 2021 to December 2022 as the study objects
Who may be able to join
- diagnosed with gastric cancer by endoscopy or pathology; age >60 years old; radical gastrectomy was proposed; be able to communicate simply in writing and verbal.
Who cannot join
- received preoperative radiotherapy or chemotherapy; combined with other sites of malignant tumors; combined with severe heart, liver, lung and renal insufficiency; recent using hormones, immunosuppressants; with physical disabilities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BIA-measured Skeletal Muscle Mass Used to Assess Frailty in Older Gastric Cancer Patients
The primary aim of this study was to quantify the diagnosis of pre-surgical skeletal muscle mass in elderly gastric cancer patients and to analyse its correlation with frailty. The second aim was to investigate whether skeletal muscle mass, or sarcopenia, is associated with mobility and nutritional status, and anxiety and depression. The main questions it aims to answer are whether skeletal muscle mass is significantly associated with frailty and whether it can be used as a brief screening tool for preoperative frailty.
- Conditions
- Gastric (Stomach) Cancer, Frailty, Sarcopenia, Malnutrition Elderly
- Being tested
- Skeletal muscle mass and frailty
- Keywords
- gastric cancer, skeletal muscle mass, frailty, sarcopenia
- Medical subject headings
- Stomach Neoplasms, Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skeletal muscle mass and frailtyOther
Measurement correlation variable
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle mass
Skeletal muscle mass was measured by bioelectrical impedance analysis(BIA) and was classified as sarcopenia if it was less than 7.0 kg/m2 in men and 5.7 kg/m2 in women.
Measured: Within 24 hours of admission
frailty
The Tilburg frailty scale was used to assess the frailty of older people with gastric cancer. The Tilburg frailty scale was compiled by Gobbens et al. The scale contains 15 items in three dimensions of physical, psychological and social frailty. The total score of the scale is 0-15 points and the cut-off value of the total scale was 5, with higher score indicating more severe frailty.
Measured: Within 24 hours of admission and discharge
Secondary outcomes (2)
Nutritional Status
The Mini Nutritional Assessment Short-form (MNA SF) scale was used to assess the nutritional status of older people with gastric cancer, which was a simplified version of the MNA scale developed by Rubenstein et al[. The total score of this scale is 14, 12~14 points indicate normal nutrition, 8~11 points indicate the risk of nutrition, ≤7 points indicate malnutrition.
Measured: Within 24 hours of admission and discharge
anxiety and depression
Anxiety and Depression in older people with gastric cancer were assessed by the Chinese version of the Hospital Anxiety and Depression Scale (HADS), which was developed by Zigmond AS et al[23]. The scale has 14 items, 7 of which are used to assess depressed and 7 of which are used to assess anxiety. Each item has a score of 1-4 point and a total score of more than 7 indicates the presence of anxiety or depression.
Measured: Within 24 hours of admission and discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Mar 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric (Stomach) 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
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinning Guo, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763068
- Sponsor's protocol ID
- 2020-273-2
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The article has not yet been published
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIA-measured Skeletal Muscle Mass Used to Assess Frailty in Older Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT06763068
- Acronym / sponsor ID
- 2020-273-2
- Conditions
- Gastric (Stomach) Cancer, Frailty, Sarcopenia, Malnutrition Elderly
- Keywords
- gastric cancer, skeletal muscle mass, frailty, sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Jan 2025 (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 primary aim of this study was to quantify the diagnosis of pre-surgical skeletal muscle mass in elderly gastric cancer patients and to analyse its correlation with frailty. The second aim was to investigate whether skeletal muscle mass, or sarcopenia, is associated with mobility and nutritional status, and anxiety and depression. The main questions it aims to answer are whether skeletal muscle mass is significantly associated with frailty and whether it can be used as a brief screening tool for preoperative frailty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience sampling method was used to select older people with gastric cancer who attended a tertiary care hospital in China from March 2021 to December 2022 as the study objects
Key inclusion criteria (1 listed)
- diagnosed with gastric cancer by endoscopy or pathology; age >60 years old; radical gastrectomy was proposed; be able to communicate simply in writing and verbal.
Key exclusion criteria (1 listed)
- received preoperative radiotherapy or chemotherapy; combined with other sites of malignant tumors; combined with severe heart, liver, lung and renal insufficiency; recent using hormones, immunosuppressants; with physical disabilities.
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 |
|---|---|---|
| Skeletal muscle mass and frailtyMeasurement correlation variable | Other | – |
Primary outcome
Skeletal muscle mass
Time frame: Within 24 hours of admission
Skeletal muscle mass was measured by bioelectrical impedance analysis(BIA) and was classified as sarcopenia if it was less than 7.0 kg/m2 in men and 5.7 kg/m2 in women.
frailty
Time frame: Within 24 hours of admission and discharge
The Tilburg frailty scale was used to assess the frailty of older people with gastric cancer. The Tilburg frailty scale was compiled by Gobbens et al. The scale contains 15 items in three dimensions of physical, psychological and social frailty. The total score of the scale is 0-15 points and the cut-off value of the total scale was 5, with higher score indicating more severe frailty.
2 secondary outcomes
Nutritional Status
Time frame: Within 24 hours of admission and discharge
anxiety and depression
Time frame: Within 24 hours of admission and discharge
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 8 Jan 2025.
- Individual participant dataSharing planned: No. The article has not yet been published
Related trials for Gastric (Stomach) Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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 (Stomach) Cancer and Frailty, 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 1 inclusion and 1 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 8 Jan 2025. 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?
Skeletal muscle mass (time frame: Within 24 hours of admission). 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 8 Jan 2025.