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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06730477
Enrollment
500
Registered
2024-12-12
Start date
2021-01-01
Completion date
2027-12-30
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR Activating Mutation, Lung Adenocarcinoma

Brief 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. 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

OTHERobservational study

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

Sponsors

Yichang Central People's Hospital
CollaboratorOTHER
Suizhou Hospital, Hubei University of Medicine
CollaboratorUNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
progression-free survivalA 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.

Secondary

MeasureTime frameDescription
Overall survivalA 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)The survival time after receiving targeted therapy combined with or without chemotherapy as first-line treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026