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

NCT06730477 | Enrolling By Invitation

• 1 other identifier: XHJY20240912
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Adenocarcinoma; EGFR Activating Mutation

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  The time of disease progression is evaluated according to the Response Evaluation Criteria in Solid Tumors, version 1.1.

  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

  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)

Study Arms (3)

Untreated EGFR mutated lung adenocarcinoma patients

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

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.

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.

Other: observational study

Interventions

observational study 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 who are responding to targeted therapy; Untreated EGFR mutated lung adenocarcinoma patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• History of other malignant tumors
• Irregular treatment or poor compliance
• Incomplete clinical information or lost to follow-up

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Yichang Central People's Hospital: collaborator
• Suizhou Hospital, Hubei University of Medicine: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and tumor tissues will be retained

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Observation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy dean

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: December 12, 2024
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)