NSCLC (Advanced Non-small Cell Lung Cancer)MPE-NSCLCNCT07262671
Predictive Value of Exosomes in Pleural Effusion for Advanced Lung Cancer
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer), run by Fudan University at 1 site in China.
Trial summary
The goal of this observational study is to investigate the predictive value of exosome characteristics in patients with advanced non-small cell lung cancer (NSCLC) and malignant pleural effusion (MPE). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer)
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2025to 16 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll approximately 100-120 patients with histologically or cytologically confirmed stage IV NSCLC who present with MPE and are scheduled to receive standard systemic therapy (including but not limited to immunotherapy, chemotherapy, or targeted therapy).
Who may be able to join
- Confirmed advanced-NSCLC Aged 18-75 years. ECOG performance status of 0-1. At least one measurable lesion as per RECIST 1.1. Adequate bone marrow, liver, and renal function. Willing and able to provide written informed consent.
Who cannot join
- Mixed small cell lung cancer histology. Symptomatic or untreated brain metastases. Uncontrolled cardiovascular diseases or severe comorbidities. Active hepatitis B/C or HIV infection.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Cancer hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Exosome Detection for Predicting Treatment Efficacy in Advanced NSCLC With Malignant Pleural Effusion
The goal of this observational study is to investigate the predictive value of exosome characteristics in patients with advanced non-small cell lung cancer (NSCLC) and malignant pleural effusion (MPE). The main question it aims to answer is:
Can the long RNA profile of exosomes derived from plasma and malignant pleural effusion predict treatment response in patients with advanced NSCLC and MPE? Participants who are scheduled to receive standard systemic therapy (including immunotherapy, chemotherapy, or targeted therapy) as part of their regular medical care will be enrolled. Researchers will collect paired samples of peripheral blood and malignant pleural effusion at baseline and key time points during treatment to analyze the exosomal long RNA profiles and correlate them with treatment efficacy and survival outcomes.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC-MPE | advanced NSCLC with Malignant Pleural Effusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
Primary Objective: To investigate the association between baseline exLR expression profiles in plasma and malignant pleural effusion and the objective response rate (ORR) as assessed by RECIST 1.1 in patients with advanced NSCLC and MPE receiving systemic therapy.
Measured: From date of enrollment until the first documented progression or death from any cause, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start16 Oct 2025
- Primary completion16 Oct 2027 (estimated)
- Study completion16 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
- Investigators
- Jialei Wang, MD, Principal investigator, Shanghai Cancer hospital Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262671
- Sponsor's protocol ID
- MPE-NSCLC-2025
- Acronym
- MPE-NSCLC
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosome Detection for Predicting Treatment Efficacy in Advanced NSCLC With Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT07262671
- Acronym / sponsor ID
- MPE-NSCLC / MPE-NSCLC-2025
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 16 Oct 2027 (estimated)
- Study completion
- 16 Oct 2030 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to investigate the predictive value of exosome characteristics in patients with advanced non-small cell lung cancer (NSCLC) and malignant pleural effusion (MPE). The main question it aims to answer is:
Can the long RNA profile of exosomes derived from plasma and malignant pleural effusion predict treatment response in patients with advanced NSCLC and MPE? Participants who are scheduled to receive standard systemic therapy (including immunotherapy, chemotherapy, or targeted therapy) as part of their regular medical care will be enrolled. Researchers will collect paired samples of peripheral blood and malignant pleural effusion at baseline and key time points during treatment to analyze the exosomal long RNA profiles and correlate them with treatment efficacy and survival outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC-MPE | – | –advanced NSCLC with Malignant Pleural Effusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll approximately 100-120 patients with histologically or cytologically confirmed stage IV NSCLC who present with MPE and are scheduled to receive standard systemic therapy (including but not limited to immunotherapy, chemotherapy, or targeted therapy).
Key inclusion criteria (1 listed)
- Confirmed advanced-NSCLC Aged 18-75 years. ECOG performance status of 0-1. At least one measurable lesion as per RECIST 1.1. Adequate bone marrow, liver, and renal function. Willing and able to provide written informed consent.
Key exclusion criteria (1 listed)
- Mixed small cell lung cancer histology. Symptomatic or untreated brain metastases. Uncontrolled cardiovascular diseases or severe comorbidities. Active hepatitis B/C or HIV infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
objective response rate (ORR)
Time frame: From date of enrollment until the first documented progression or death from any cause, assessed up to 24 months.
Primary Objective: To investigate the association between baseline exLR expression profiles in plasma and malignant pleural effusion and the objective response rate (ORR) as assessed by RECIST 1.1 in patients with advanced NSCLC and MPE receiving systemic therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jialei Wang, MD principal investigator
Shanghai Cancer hospital Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC (Advanced Non-small Cell Lung Cancer), run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: From date of enrollment until the first documented progression or death from any cause, assessed up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.