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Plasma Exosomes Reveal the Efficacy of Targeted Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma

NCT ID: NCT06730477

Last Updated: 2024-12-12

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

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2027-12-30

Brief Summary

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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

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The medical imaging data will be collected retrospectively and prospectively, and the blood samples and tumor tissues will be collected prospectively.

Conditions

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Lung Adenocarcinoma EGFR Activating Mutation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Untreated EGFR mutated lung adenocarcinoma patients

Patients diagnosed with lung adenocarcinoma with EGFR mutations for the first time.

observational study

Intervention Type OTHER

Efficacy of targeted therapy combined with or without chemotherapy as first-line therapy in patients with EGFR-mutated lung adenocarcinoma.

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.

observational study

Intervention Type OTHER

Efficacy of targeted therapy combined with or without chemotherapy as first-line therapy in patients with EGFR-mutated lung adenocarcinoma.

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.

observational study

Intervention Type OTHER

Efficacy of targeted therapy combined with or without chemotherapy as first-line therapy in patients with EGFR-mutated lung adenocarcinoma.

Interventions

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observational study

Efficacy of targeted therapy combined with or without chemotherapy as first-line therapy in patients with EGFR-mutated lung adenocarcinoma.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* History of other malignant tumors
* Irregular treatment or poor compliance
* Incomplete clinical information or lost to follow-up
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yichang Central People's Hospital

OTHER

Sponsor Role collaborator

Suizhou Hospital, Hubei University of Medicine

UNKNOWN

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Yang Jin

deputy dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Union hospital, Tongji Medical college, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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XHJY20240912

Identifier Type: -

Identifier Source: org_study_id