Organoid-guided Personalized Treatment of Pleural Effusion

NCT ID: NCT06959173

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-21
• Study Completion Date: 2027-01-31

Brief Summary

The study is a single-arm, single-center clinical research that utilizes patient-derived tumor organoids to predict drug sensitivity, thereby assisting clinicians in formulating treatment plans to benefit lung cancer patients with pleural effusion.

This study is divided into three parts: acquisition of clinical samples from patients, in vitro organoid culture and drug sensitivity testing, and correlation of organoid sensitivity results with clinical medication guidance. Researchers obtained pre-treatment tissue samples and provided them to Suzhou Xianjue Biotechnology Co., Ltd. to establish organoid models. Once established, drug incubation was performed for sensitivity testing. Subsequently, treatment for malignant pleural effusion was guided based on drug sensitivity data.

Detailed Description

Research name：Organoid-guided personalized treatment of pleural effusion.

Intervention study: Not have.

Research design: The study is a single-arm, single-center clinical research that utilizes patient-derived tumor organoids to predict drug sensitivity, thereby assisting clinicians in formulating treatment plans to benefitlung cancer patients with pleural effusion.

This study is divided into three parts: acquisition of clinical samples from patients, in vitro organoid culture and drug sensitivity testing, and correlation of organoid sensitivity results with clinical medication guidance. Researchers obtained pre-treatment tissue samples and provided them to Suzhou Xianjue Biotechnology Co., Ltd. to establish organoid models. Once established, drug incubation was performed for sensitivity testing. Subsequently, treatment for malignant pleural effusion was guided based on drug sensitivity data.

Sample capacity: 20.

Purpose of research: The purpose of this study is to use the patient-derived organoid model for drug sensitivity testing, to explore the patient-derived organoids for drug sensitivity prediction, so as to achieve the benefit of lung cancer patients with pleural effusion.

Fundamental purpose: Assessment of the efficacy of pleural effusion therapy guided by patient-derived organoid drug sensitivity prediction.

Secondary purpose: Agreement of organoid drug prediction and actual clinical benefit.

Inclusion Criteria:

(1)18 years of age and above; (2) Understand and voluntarily sign the informed consent form (ICF), and have good compliance, and can cooperate with diagnosis and follow-up; (3)ECOG score 0-2; (4) Accompanied by malignant pleural effusion; Presence of at least one measurable lesion as assessed by the investigator;

Exclusion Criteria:

1. A history of malignant tumor in the past 5 years;

2. Complicated with serious complications, such as uncontrolled heart disease, severe arrhythmia requiring medical treatment, persistent watery diarrhea, etc.;

3. Pregnant or lactating female patients; Patients deemed unsuitable for participation in this study.

Study termination criteria: Reasons for subject withdrawal from the study may include:

1. The subject withdrew his informed consent. Subjects were free to terminate study participation at any time without being compromised in further treatment. If the subject withdraws informed consent, they will be asked in detail if they agree to participate in safety follow-up, continue efficacy assessment (if not progressing), and survival follow-up;

2. Subjects were lost to follow-up;

3. die;

4. Other reasons.

Visit the plan: Treatment follow-up for 2 years:

1. Follow-up visits are made every 8 weeks and ± 7 days within 1 year after enrollment (within 48 weeks);

2. Patients will be followed up every 12 weeks ± 7 days within the 1 to 2 years after enrollment (within weeks 49 to 96).

Statistical analysis: Data analysis will be performed using the SPSS statistical software.

Conditions

Lung Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

(1)18 years of age and above; (2) Understand and voluntarily sign the informed consent form (ICF), and have good compliance, and can cooperate with diagnosis and follow-up; (3)ECOG score 0-2; (4) Accompanied by malignant pleural effusion; Presence of at least one measurable lesion as assessed by the investigator;

Exclusion Criteria

1. A history of malignant tumor in the past 5 years;

2. Complicated with serious complications, such as uncontrolled heart disease, severe arrhythmia requiring medical treatment, persistent watery diarrhea, etc.;

3. Pregnant or lactating female patients; Patients deemed unsuitable for participation in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Qiming Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henan cancer hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiming Wang

Role: CONTACT

qimingwang1006@126.com

13783590691

Sen Yang

Role: CONTACT

yangsenkf@163.com

15515613603

Facility Contacts

Bao xia He

Role: primary

hnszlyygcp@163.com

13283809085

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Other Identifiers

2024-592

Identifier Type: -

Identifier Source: org_study_id