Lung AdenocarcinomaNCT06730477
Plasma Exosomes Reveal the Efficacy of Targeted Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma
An observational study of Lung Adenocarcinoma and EGFR Activating Mutation, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The objective of this observational study is to explore the therapeutic trajectory of targeted therapy in lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Adenocarcinoma, EGFR Activating Mutation
- What is being tested?
- observational study
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Dec 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2021 to December 2026, about 500 patients with EGFR-mutated lung adenocarcinoma who receive targeted therapy with or without chemotherapy as first-line treatment will be included in this cohort study
Who may be able to join
- Pathological examination confirmed lung adenocarcinoma
- No other type of tumor was present
- Common sensitive EGFR (Ex19Del L858R or combined with other sites) mutations have been identified
- Receive targeted therapy with or without chemotherapy as first-line treatment
- ≥ 18 years and ≤80 years old
Who cannot join
- History of other malignant tumors
- Irregular treatment or poor compliance
- Incomplete clinical information or lost to follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Union hospital, Tongji Medical college, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: Based on Plasma Exosomes Combined With Multi-omics Analysis to Reveal the Trajectory of Targeted Therapy Resistance and Novel Target Intervention Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma
The objective of this observational study is to explore the therapeutic trajectory of targeted therapy in lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutations. The main objective is to identify potential biomarkers that can predict the efficacy of targeted therapy through plasma exosomes and to explore strategies to reverse drug resistance to targeted therapy. Biological specimens and medical imaging data will be collected from patients already receiving targeted therapy as a first-line treatment, and followed-up will be conducted to analyze prognosis based on different patterns.
Read the detailed description
The medical imaging data will be collected retrospectively and prospectively, and the blood samples and tumor tissues will be collected prospectively.
- Conditions
- Lung Adenocarcinoma, EGFR Activating Mutation
- Being tested
- observational study
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
Efficacy of targeted therapy combined with or without chemotherapy as first-line therapy in patients with EGFR-mutated lung adenocarcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Untreated EGFR mutated lung adenocarcinoma patients | Patients diagnosed with lung adenocarcinoma with EGFR mutations for the first time. Receives: Other: observational study | |
| Patients with EGFR-mutated lung adenocarcinoma who are responding to targeted therapy | Patients with EGFR-mutated lung adenocarcinoma treated with targeted therapy combined with or without chemotherapy as first-line therapy, and the therapeutic effect was in the response stage. Receives: Other: observational study | |
| Patients with EGFR-mutated lung adenocarcinoma who are resistant to targeted therapy | Patients with EGFR-mutated lung adenocarcinoma treated with targeted therapy combined with or without chemotherapy as first-line therapy, and the therapeutic effect was in drug resistance stage, or disease progression. Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
The time of disease progression is evaluated according to the Response Evaluation Criteria in Solid Tumors, version 1.1.
Measured: A two-year period after starting treatment (Regular follow-up every three months after receiving targeted therapy combined with or without chemotherapy as first-line treatment)
Secondary outcomes (1)
Overall survival
The survival time after receiving targeted therapy combined with or without chemotherapy as first-line treatment
Measured: A three-year period after starting treatment (Regular follow-up every six months after receiving targeted therapy combined with or without chemotherapy as first-line treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Jan 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Yichang Central People's Hospital, Suizhou Hospital, Hubei University of Medicine
- Responsible party
- Principal investigator, Yang Jin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730477
- Sponsor's protocol ID
- XHJY20240912
- Status last verified
- Dec 2024
- First submitted
- 12 Sep 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Based on Plasma Exosomes Combined With Multi-omics Analysis to Reveal the Trajectory of Targeted Therapy Resistance and Novel Target Intervention Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06730477
- Acronym / sponsor ID
- XHJY20240912
- Conditions
- Lung Adenocarcinoma, EGFR Activating Mutation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Yichang Central People's Hospital, Suizhou Hospital, Hubei University of Medicine
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 12 Dec 2024 (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 objective of this observational study is to explore the therapeutic trajectory of targeted therapy in lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutations. The main objective is to identify potential biomarkers that can predict the efficacy of targeted therapy through plasma exosomes and to explore strategies to reverse drug resistance to targeted therapy. Biological specimens and medical imaging data will be collected from patients already receiving targeted therapy as a first-line treatment, and followed-up will be conducted to analyze prognosis based on different patterns.
Detailed description
The medical imaging data will be collected retrospectively and prospectively, and the blood samples and tumor tissues will be collected prospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Untreated EGFR mutated lung adenocarcinoma patients | – | Other: observational studyPatients diagnosed with lung adenocarcinoma with EGFR mutations for the first time. |
| Patients with EGFR-mutated lung adenocarcinoma who are responding to targeted therapy | – | Other: observational studyPatients with EGFR-mutated lung adenocarcinoma treated with targeted therapy combined with or without chemotherapy as first-line therapy, and the therapeutic effect was in the response stage. |
| Patients with EGFR-mutated lung adenocarcinoma who are resistant to targeted therapy | – | Other: observational studyPatients with EGFR-mutated lung adenocarcinoma treated with targeted therapy combined with or without chemotherapy as first-line therapy, and the therapeutic effect was in drug resistance stage, or disease progression. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2021 to December 2026, about 500 patients with EGFR-mutated lung adenocarcinoma who receive targeted therapy with or without chemotherapy as first-line treatment will be included in this cohort study
Key inclusion criteria (5 listed)
- Pathological examination confirmed lung adenocarcinoma
- No other type of tumor was present
- Common sensitive EGFR (Ex19Del L858R or combined with other sites) mutations have been identified
- Receive targeted therapy with or without chemotherapy as first-line treatment
- ≥ 18 years and ≤80 years old
Key exclusion criteria (3 listed)
- History of other malignant tumors
- Irregular treatment or poor compliance
- Incomplete clinical information or lost to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyEfficacy of targeted therapy combined with or without chemotherapy as first-line therapy in patients with EGFR-mutated lung adenocarcinoma. | Other | Patients with EGFR-mutated lung adenocarcinoma who are resistant to targeted therapy, Patients with EGFR-mutated lung adenocarcinoma who are responding to targeted therapy, Untreated EGFR mutated lung adenocarcinoma patients |
Primary outcome
progression-free survival
Time frame: A two-year period after starting treatment (Regular follow-up every three months after receiving targeted therapy combined with or without chemotherapy as first-line treatment)
The time of disease progression is evaluated according to the Response Evaluation Criteria in Solid Tumors, version 1.1.
1 secondary outcome
Overall survival
Time frame: A three-year period after starting treatment (Regular follow-up every six months after receiving targeted therapy combined with or without chemotherapy as first-line treatment)
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 12 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Adenocarcinoma and EGFR Activating Mutation, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 5 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 12 Dec 2024. 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?
progression-free survival (time frame: A two-year period after starting treatment (Regular follow-up every three months after receiving targeted therapy combined with or without chemotherapy as first-line treatment)). 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 12 Dec 2024.