Gastric CancerNCT06689462
Appraisal of the Modified Cancer Cachexia Index in Locally Advanced Gastric Cancer Patients Undergoing Neoadjuvant Chemotherapy
An observational study of Gastric Cancer and Neoadjuvant Chemotherapy, run by Fujian Medical University at 1 site in China.
Trial summary
In this study, consecutive 600 patients with LAGC(cT2-4NanyM0) who underwent NACT between Jan. 2010 and Jun. 2022 were identified from two tertiary hospitals. The mCXI was constructed based on Random Forest model, calculated as (post-NACT L3 subcutaneous adipose tissue area [SAT])×(post-NACT serum albumin… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Gastric Cancer, Neoadjuvant Chemotherapy, Computed Tomography
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 13 Jul 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with locally advanced gastric cancer (cT2-4NanyM0)
Who may be able to join
- (1) locally advanced gastric cancer (cT2-4NxM0) with clinical staging before neoadjuvant chemotherapy, (2) no history of other malignant tumors, (3) no evidence of distant metastasis or invasion of adjacent organs, and (4) patients who underwent radical gastrectomy following neoadjuvant chemotherapy.
Who cannot join
- (1) history of gastric surgery; (2) acute cardiovascular disease (such as cerebrovascular or coronary artery injury) within the past three months; (3) emergency surgery; (4) active infection or severe systemic immunodeficiency; and (5) incomplete serological, computed tomography, or anthropometric data.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, consecutive 600 patients with LAGC(cT2-4NanyM0) who underwent NACT between Jan. 2010 and Jun. 2022 were identified from two tertiary hospitals. The mCXI was constructed based on Random Forest model, calculated as (post-NACT L3 subcutaneous adipose tissue area [SAT])×(post-NACT serum albumin [ALB])/(post-NACT platelet count [PLT]). Patients were categorized into two subgroups: mCXI-low and mCXI-high. mCXI is associated with the overall prognosis in patients with locally advanced gastric cancer underwent neoadjuvant chemotherapy, is superior to traditional CXI, and may serve as a decision-making tool for guiding personalized postoperative adjuvant chemotherapy.
Read the detailed description
This is a multicenter retrospective cohort study
- Keywords
- Cancer cachexia index, Locally Advanced Gastric Cancer, Neoadjuvant chemotherapy, Adjuvant chemotherapy, Survival
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival
Survival status at 3 years: survival, death, the end of surgery to death.
Measured: 3 years or 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Dec 2023
- Primary completion30 Jun 2024
- Study completion13 Jul 2024
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 Fujian 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
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Chang-Ming Huang, M.D. FACS, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689462
- Sponsor's protocol ID
- 2024NLAGCCachexia
- Other IDs
- 2022QNA026
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appraisal of the Modified Cancer Cachexia Index in Locally Advanced Gastric Cancer Patients Undergoing Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06689462
- Acronym / sponsor ID
- 2024NLAGCCachexia
- Keywords
- Cancer cachexia index, Locally Advanced Gastric Cancer, Neoadjuvant chemotherapy, Adjuvant chemotherapy, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 13 Jul 2024 (actual)
- First posted
- 14 Nov 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.
In this study, consecutive 600 patients with LAGC(cT2-4NanyM0) who underwent NACT between Jan. 2010 and Jun. 2022 were identified from two tertiary hospitals. The mCXI was constructed based on Random Forest model, calculated as (post-NACT L3 subcutaneous adipose tissue area [SAT])×(post-NACT serum albumin [ALB])/(post-NACT platelet count [PLT]). Patients were categorized into two subgroups: mCXI-low and mCXI-high. mCXI is associated with the overall prognosis in patients with locally advanced gastric cancer underwent neoadjuvant chemotherapy, is superior to traditional CXI, and may serve as a decision-making tool for guiding personalized postoperative adjuvant chemotherapy.
Detailed description
This is a multicenter retrospective cohort study
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with locally advanced gastric cancer (cT2-4NanyM0)
Key inclusion criteria (1 listed)
- (1) locally advanced gastric cancer (cT2-4NxM0) with clinical staging before neoadjuvant chemotherapy, (2) no history of other malignant tumors, (3) no evidence of distant metastasis or invasion of adjacent organs, and (4) patients who underwent radical gastrectomy following neoadjuvant chemotherapy.
Key exclusion criteria (1 listed)
- (1) history of gastric surgery; (2) acute cardiovascular disease (such as cerebrovascular or coronary artery injury) within the past three months; (3) emergency surgery; (4) active infection or severe systemic immunodeficiency; and (5) incomplete serological, computed tomography, or anthropometric data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3-year overall survival
Time frame: 3 years or 36 months.
Survival status at 3 years: survival, death, the end of surgery to death.
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 14 Nov 2024.
- 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.
Chang-Ming Huang, M.D. FACS principal investigator
Fujian Medical University Union Hospital
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 and Neoadjuvant Chemotherapy, run by Fujian 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 14 Nov 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?
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?
3-year overall survival (time frame: 3 years or 36 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 14 Nov 2024.