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

NCT ID: NCT06100003

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-18

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Organoids

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Health and Medical Technology, Hefei Institutes of Physical Science, Chinese Academy of Sciences

UNKNOWN

Sponsor Role collaborator

Precedo Pharmaceuticals Co. Ltd.

UNKNOWN

Sponsor Role collaborator

Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou 215163, China

UNKNOWN

Sponsor Role collaborator

Funan Liu

OTHER

Sponsor Role lead

Responsible Party

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Funan Liu

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhenning Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of China Medical Univeristy

Funan Liu, doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of China Medical Univeristy

Locations

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Phase I Clinical Trials Center Of The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuhui Song, bachelor

Role: CONTACT

83281137 ext. 024

Facility Contacts

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Shuhui Song

Role: primary

02483281137

Other Identifiers

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ZKPRS-CMU1H-01

Identifier Type: -

Identifier Source: org_study_id

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