CachexiaNCT06277986
Early Diagnosis of Gastric Cancer Cachexia
An observational study of Cachexia, run by Xijing Hospital at 1 site in China.
Trial summary
Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia
- What is being tested?
- cachexia
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The research object is patients with confirmed gastric cancer.According to diagnostic criteria, patients are divided into cachexia group and non-cachexia group.
Who may be able to join
- Patients with gastric cancer diagnosed by histopathology or cytopathology
- Complete clinical and pathological data
- No previous or current mental illness or disturbance of consciousness
Who cannot join
- With multiple tumors or other malignant diseases
- Combined with other chronic wasting and metabolic diseases
- Past patients with non-tumor cachexia
- People with mental illness or unable to cooperate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fourth Military Medical University
Xi'an, Shaanxi
Jipeng Li, +86-029-84771533
About this study
Official title: Clinical Value of Tumor Cell-derived Exosomal miRNA in Early Diagnosis of Gastric Cancer Cachexia
Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia.
Read the detailed description
Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In gastric cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia.
- Conditions
- Cachexia
- Being tested
- cachexia
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cachexiaOther
Cachexia mainly manifests as weight loss. 1)weight loss >5% over past 6 months. 2)BMI<20 and any degree of weight loss >2%. 3)Appendicular skeletal muscle index consistent with sarcopenia and any degree of weight loss >2%.
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer patients with non-cachexia | Not described Receives: Other: cachexia | |
| Gastric cancer patients with cachexia | Not described Receives: Other: cachexia |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Calculate BMI based on changes in body weight in the past six months
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jun 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277986
- Sponsor's protocol ID
- KY20212018-F-2
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Tumor Cell-derived Exosomal miRNA in Early Diagnosis of Gastric Cancer Cachexia
- ClinicalTrials.gov ID
- NCT06277986
- Acronym / sponsor ID
- KY20212018-F-2
- Conditions
- Cachexia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 26 Feb 2024 (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.
Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia.
Detailed description
Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In gastric cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer patients with non-cachexia | – | Other: cachexia |
| Gastric cancer patients with cachexia | – | Other: cachexia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The research object is patients with confirmed gastric cancer.According to diagnostic criteria, patients are divided into cachexia group and non-cachexia group.
Key inclusion criteria (3 listed)
- Patients with gastric cancer diagnosed by histopathology or cytopathology
- Complete clinical and pathological data
- No previous or current mental illness or disturbance of consciousness
Key exclusion criteria (4 listed)
- With multiple tumors or other malignant diseases
- Combined with other chronic wasting and metabolic diseases
- Past patients with non-tumor cachexia
- People with mental illness or unable to cooperate
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 |
|---|---|---|
| cachexiaCachexia mainly manifests as weight loss. 1)weight loss >5% over past 6 months. 2)BMI<20 and any degree of weight loss >2%. 3)Appendicular skeletal muscle index consistent with sarcopenia and any degree of weight loss >2%. | Other | Gastric cancer patients with cachexia, Gastric cancer patients with non-cachexia |
Primary outcome
BMI
Time frame: six months
Calculate BMI based on changes in body weight in the past six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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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.
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 Cachexia, run by Xijing Hospital 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 4 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 26 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jipeng Li (+86-029-84771533, jiangxunliang1992@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: six months). 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 26 Feb 2024.