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

NCT06573307 | Completed DMC

• 1 other identifier: FMUUH-0323
• Study Type: observational
• Target: 442
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Gastric cancer; Neoadjuvant chemotherapy; inflammation; Oxidative stress; Treatment response; Risk stratification

Outcome Measures

Primary Outcomes (3)

• 3-year OS

  Overall survival, death, survival with tumor

  3-year OS or 36 months

• 3-year DFS

  Disease-free survival, death,recurrence

  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.

  3 years or 36 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chang-Ming Huang, Prof.: lead

Study Sites (1)

Department of Gastric Surgery， Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Changming Huang

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 27, 2024
• Study Start: June 10, 2024
• Primary Completion: August 10, 2024
• Study Completion: August 26, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)