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Enrolling by invitation NCT06730477

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

Observational Lung Adenocarcinoma EGFR Activating Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: observational study.
Who it may be relevant to
Registry conditions: Lung Adenocarcinoma, EGFR Activating Mutation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

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

Primary outcome measures

  • 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)]
Secondary outcome measures (1)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Union hospital, Tongji Medical college, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT06730477 · XHJY20240912

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗