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Completed

NCT Number: NCT06573307

Hematological Dynamic Scores for Predicting Survival and Treatment Response for Advanced Gastric Cancer After Neoadjuvant Therapy

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastric Surgery, Fujian Medical University Union Hospital

Fuzhou, Fujian, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Treatment and study plan

Primary outcomes

  1. 3-year OS

    Time frame: 3-year OS or 36 months

    Overall survival, death, survival with tumor

  2. 3-year DFS

    Time frame: 3 years DFS or 36 months

    Disease-free survival, death,recurrence

  3. 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.

Sponsors and collaborators

Lead sponsor

Chang-Ming Huang, Prof.

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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