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Clinical Trials/NCT06100003
NCT06100003
Recruiting
N/A

A Real-world Observational Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Gastric Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method

Funan Liu1 site in 1 country104 target enrollmentOctober 18, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
Funan Liu
Enrollment
104
Locations
1
Primary Endpoint
Specificity
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The study is a real-world observational clinical study. Patients diagnosed as gastric cancer through histopathology were screened and enrolled. Before anti-tumor treatment, gastroscopy biopsy tissue specimens, surgical specimens, and malignant pleural effusion or ascites specimens, etc. are collected. The investigators will perform a drug sensitivity testing based on a novel drug susceptibility testing method to test the commonly used anti-tumor treatment regimens. Patients were given conventional anti-tumor treatment according to the medical judgment of the doctors. Finally, the investigator will evaluate the consistency of clinical efficacy in gastric cancer treatment and drug susceptibility outcomes.

Registry
clinicaltrials.gov
Start Date
October 18, 2023
End Date
December 1, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Funan Liu
Responsible Party
Sponsor Investigator
Principal Investigator

Funan Liu

professor

China Medical University, China

Eligibility Criteria

Inclusion Criteria

  • Male or female, aged ≥ 18 and ≤80;
  • Patients with gastric cancer diagnosed by histopathology;
  • Patients who need neoadjuvant treatment; adjuvant therapy after radical surgery or palliative treatment;
  • Fresh tumor tissue specimens or malignant pleural effusion or ascites can be obtained;
  • Patients who sign the informed consent form, and are able to comply with the study period treatment process.

Exclusion Criteria

  • Inability to follow the research protocol;
  • Inability to obtain relevant fresh specimens by biopsy/surgery/puncture;
  • Concomitant contraindications to chemotherapy;
  • pregnant or lactating women;
  • Patients deemed inappropriate by investigators.

Outcomes

Primary Outcomes

Specificity

Time Frame: Through study completion, an average of 1 year

Cases in which drug susceptibility results are resistance to the antineoplastic regimen as a percentage of the cases that are ineffective in clinical evaluation

Disease-free survival

Time Frame: From date of surgery until the date of first documented recurrence,up to 3 years

An Indicator of efficacy of postoperative adjuvant therapy

Sensitivity

Time Frame: Through study completion, an average of 1 year

Cases in which drug susceptibility results are sensitive to the antineoplastic regimen as a percentage of the cases that are effective in clinical evaluation

Study Sites (1)

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