Gastric CancerNCT06573307
Hematological Dynamic Scores for Predicting Survival and Treatment Response for Advanced Gastric Cancer After Neoadjuvant Therapy
An observational study of Gastric Cancer, run by Chang-Ming Huang, Prof. at 1 site in China.
Trial summary
HMDLS, based on hematological markers, could effectively distinguish the long-term efficacy of AGC patients after NAT. The predictive performance of nomogram-HMDLS was better than ypTNM stage, achieving better prognostic stratification and tumor treatment response prediction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer
- How many people
- 442 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2024to 26 Aug 2024
- How long will I take part?
- 36 Months
- 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: In this study, we retrospectively collected clinicopathologic data and hematological markers before Neoadjuvant therapy and surgery in AGC patients who had undergone Neoadjuvant therapy and received radical gastrectomy in five hospitals.
Who may be able to join
- (1) AGC with clinical stage T2-4NxM0 (cT2-4NxM0) before NAT, (2) no history of other malignant tumors, distant metastases or invasion of adjacent organs, and (3) patients who underwent radical gastrectomy after receiving NAT.
Who cannot join
- (1) history of upper abdominal surgery (except for the laparoscopic cholecystectomy), (2) history of upper abdominal radiotherapy, (3) emergency surgery, or palliative surgery, (4) continuous use of medications such as anticoagulant, antiplatelet, and leukocyte-boosting drugs that significantly affect hematological markers during therapy, and (5) incomplete clinical and follow-up data.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastric Surgery， Fujian Medical University Union Hospital
Fuzhou, Fujian
About this study
Official title: To Develop a Prognostic Model for Predicting Survival and Treatment Response for Advanced Gastric Cancer Patients After Neoadjuvant Therapy by Analyzing Hematological Markers Dynamic Load
HMDLS, based on hematological markers, could effectively distinguish the long-term efficacy of AGC patients after NAT. The predictive performance of nomogram-HMDLS was better than ypTNM stage, achieving better prognostic stratification and tumor treatment response prediction.
Read the detailed description
In this research, we incorporated a total of 320 patients from the Union Hospital of Fujian Medical University to form the training cohort (TC). Additionally, we included 122 patients from four distinct medical centers to serve as the external validation cohort (EVC). The Hematological Marker Dynamic Load (ΔHMDL) was determined using the following formula: ΔHMDL = (HMDL pre-surgery - HMDL pre-NAT) / HMDL pre-NAT, where HMDL represents the hematological marker levels before surgery and before the initiation of Neoadjuvant Therapy (NAT), respectively.
Employing LASSO regression analysis, we identified the most influential and statistically significant ΔHMDL indicators. These were then utilized to compute the Hematological Marker Dynamic Load Score (HMDLS), defined as: HMDLS = Σ(LASSO coefficient * ΔHMDL), where the summation encompasses the products of the LASSO-estimated coefficients and the corresponding ΔHMDL values.
Further, leveraging the outcomes of a multivariate COX regression analysis, we integrated clinical parameters with the HMDLS to formulate a predictive model, termed the Nomogram-HMDLS model. The efficacy of this model in terms of predictive accuracy, clinical utility, and calibration was meticulously assessed and confirmed through several metrics, including the concordance index (C-index), Receiver Operating Characteristic (ROC) curve analysis, decision curve analysis (DCA), and calibration curves.
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Neoadjuvant chemotherapy, inflammation, Oxidative stress, Treatment response, Risk stratification
- Medical subject headings
- Stomach Neoplasms, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year OS
Overall survival, death, survival with tumor
Measured: 3-year OS or 36 months
3-year DFS
Disease-free survival, death,recurrence
Measured: 3 years DFS or 36 months
Tumor Regression Grade
a grade system evaluates the pathological response based on the degree of tumor tissue regression after NAT.
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 posted27 Aug 2024
- Study start10 Jun 2024
- Primary completion10 Aug 2024
- Study completion26 Aug 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.
- 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
- Other
- Enrolment
- 442 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Chang-Ming Huang, Prof.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chang-Ming Huang, Prof., Fujian Medical University
- Investigators
- Changming Huang, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573307
- Sponsor's protocol ID
- FMUUH-0323
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 27 Aug 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Develop a Prognostic Model for Predicting Survival and Treatment Response for Advanced Gastric Cancer Patients After Neoadjuvant Therapy by Analyzing Hematological Markers Dynamic Load
- ClinicalTrials.gov ID
- NCT06573307
- Acronym / sponsor ID
- FMUUH-0323
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Neoadjuvant chemotherapy, inflammation, Oxidative stress, Treatment response, Risk stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Chang-Ming Huang, Prof.University, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 27 Aug 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.
HMDLS, based on hematological markers, could effectively distinguish the long-term efficacy of AGC patients after NAT. The predictive performance of nomogram-HMDLS was better than ypTNM stage, achieving better prognostic stratification and tumor treatment response prediction.
Detailed description
In this research, we incorporated a total of 320 patients from the Union Hospital of Fujian Medical University to form the training cohort (TC). Additionally, we included 122 patients from four distinct medical centers to serve as the external validation cohort (EVC). The Hematological Marker Dynamic Load (ΔHMDL) was determined using the following formula: ΔHMDL = (HMDL pre-surgery - HMDL pre-NAT) / HMDL pre-NAT, where HMDL represents the hematological marker levels before surgery and before the initiation of Neoadjuvant Therapy (NAT), respectively.
Employing LASSO regression analysis, we identified the most influential and statistically significant ΔHMDL indicators. These were then utilized to compute the Hematological Marker Dynamic Load Score (HMDLS), defined as: HMDLS = Σ(LASSO coefficient * ΔHMDL), where the summation encompasses the products of the LASSO-estimated coefficients and the corresponding ΔHMDL values.
Further, leveraging the outcomes of a multivariate COX regression analysis, we integrated clinical parameters with the HMDLS to formulate a predictive model, termed the Nomogram-HMDLS model. The efficacy of this model in terms of predictive accuracy, clinical utility, and calibration was meticulously assessed and confirmed through several metrics, including the concordance index (C-index), Receiver Operating Characteristic (ROC) curve analysis, decision curve analysis (DCA), and calibration curves.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 36 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In this study, we retrospectively collected clinicopathologic data and hematological markers before Neoadjuvant therapy and surgery in AGC patients who had undergone Neoadjuvant therapy and received radical gastrectomy in five hospitals.
Key inclusion criteria (1 listed)
- (1) AGC with clinical stage T2-4NxM0 (cT2-4NxM0) before NAT, (2) no history of other malignant tumors, distant metastases or invasion of adjacent organs, and (3) patients who underwent radical gastrectomy after receiving NAT.
Key exclusion criteria (1 listed)
- (1) history of upper abdominal surgery (except for the laparoscopic cholecystectomy), (2) history of upper abdominal radiotherapy, (3) emergency surgery, or palliative surgery, (4) continuous use of medications such as anticoagulant, antiplatelet, and leukocyte-boosting drugs that significantly affect hematological markers during therapy, and (5) incomplete clinical and follow-up 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 OS
Time frame: 3-year OS or 36 months
Overall survival, death, survival with tumor
3-year DFS
Time frame: 3 years DFS or 36 months
Disease-free survival, death,recurrence
Tumor Regression Grade
Time frame: 3 years or 36 months
a grade system evaluates the pathological response based on the degree of tumor tissue regression after NAT.
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 27 Aug 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.
Changming Huang 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, run by Chang-Ming Huang, Prof. 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 27 Aug 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 OS (time frame: 3-year OS or 36 months). The study lists 3 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 27 Aug 2024.