A 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

February 5, 2024 updated by: Funan Liu

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shuhui Song, bachelor
  • Phone Number: 024 83281137
  • Email: 593900927@qq.com

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • Phase I Clinical Trials Center Of The First Hospital of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

patients with gastric cancer in the First Affiliated Hospital of China Medical University

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of surgery until the date of first documented recurrence，up to 3 years
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
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Funan Liu

Collaborators

Institute of Health and Medical Technology, Hefei Institutes of Physical Science, Chinese Academy of Sciences
Precedo Pharmaceuticals Co. Ltd.
Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou 215163, China

Investigators

  • Principal Investigator: Zhenning Wang, doctor, The First Affiliated Hospital of China Medical Univeristy
  • Principal Investigator: Funan Liu, doctor, The First Affiliated Hospital of China Medical Univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2023

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 7, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZKPRS-CMU1H-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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