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Trial Title: Korean Registry of Non-Small Cell Lung Cancer Patients With EGFR Mutation

NCT ID: NCT06247280

Condition: NSCLC

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Study type: Observational [Patient Registry]

Overall status: Active, not recruiting

Study design:

Time perspective: Cross-Sectional

Summary: Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR mutation to collect and analyze the patient's clinical features, diagnosis, and treatment results.

Detailed description: The Korean EGFR Registry is a prospective multicenter observational cohort study designed to enroll all stage EGFR-mutated non-small cell lung cancer (NSCLC) patients. However, due to the extended follow-up period required to confirm clinical outcomes, a retrospective cohort has been included. This retrospective cohort comprises patients with recurrent or metastatic NSCLC who began taking EGFR TKI after January 2021. The recruitment phase was planned to span 36 months, commencing in May 2022, with scheduled follow-up activities continuing until December 2026. The target enrollment for this study is set at 2,000 patients, with competitive enrollment to be carried out across 40 university hospitals in Korea.

Criteria for eligibility:

Study pop:
Patients with non-small cell lung cancer of any stage with an EGFR mutation newly diagnosed after the date of IRB approval, or patients who started EGFR-targeted therapy for the first time after 2021-01-01 with metastatic or recurrent EGFR mutation non-small cell lung cancer.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: 1. Adults over 20-year-old with Korean nationality 2. A person who voluntarily signed the informed consent form for this study 3. All stage Non small cell lung cancer patients with EGFR mutation or Metastatic or recurred EGFR mutated NSCLC patients started with EGFR TKI treatment from 2021-01-01. Exclusion Criteria: 1. A person who is not confirmed NSCLC histologically or cytologically. 2. A person who doesn't consent to the study. 3. A person who is unable to complete the study judged by the investigator.

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Kyungpook National University Chilgok Hospital

Address:
City: Chilgok
Country: Korea, Republic of

Facility:
Name: Wonju Severance Christian Hospital

Address:
City: Wonju
Country: Korea, Republic of

Facility:
Name: Hallym Univ. Medical Center. Chuncheon

Address:
City: Chuncheon
Country: Korea, Republic of

Facility:
Name: Soon Chun Hyang University Hospital Bucheon

Address:
City: Bucheon-si
Zip: 14584
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea Uijeongbu St. Mary's Hospital

Address:
City: Uijeongbu
Zip: 11765
Country: Korea, Republic of

Facility:
Name: The Catholic Univ. of Korea Bucheon ST. Mary's Hospital

Address:
City: Bucheon
Country: Korea, Republic of

Facility:
Name: Wonkwang University Hospital

Address:
City: Iksan
Country: Korea, Republic of

Facility:
Name: Inje University Haeundae Paik Hospital

Address:
City: Busan
Zip: 48108
Country: Korea, Republic of

Facility:
Name: Kosin University Gospel Hospital

Address:
City: Busan
Zip: 49267
Country: Korea, Republic of

Facility:
Name: Inje University Busan Paik Hospital

Address:
City: Busan
Country: Korea, Republic of

Facility:
Name: Pusan National University Yangsan Hospital

Address:
City: Busan
Country: Korea, Republic of

Facility:
Name: Samsung Changwon Hospital

Address:
City: Busan
Country: Korea, Republic of

Facility:
Name: Changwon Gyeongsang National University Hospital

Address:
City: Changwon
Country: Korea, Republic of

Facility:
Name: Yeungnam University Medical Center

Address:
City: Daegu
Zip: 42415
Country: Korea, Republic of

Facility:
Name: Daegu Catholic University Medical Center

Address:
City: Daegu
Country: Korea, Republic of

Facility:
Name: Keimyung University Dongsan Hospital

Address:
City: Daegu
Country: Korea, Republic of

Facility:
Name: Chungnam National University Hospital

Address:
City: Daejeon
Country: Korea, Republic of

Facility:
Name: Konyang Univ. Hospital

Address:
City: Daejeon
Country: Korea, Republic of

Facility:
Name: Cheonnam National University Hwasun Hospital

Address:
City: Hwasun
Country: Korea, Republic of

Facility:
Name: Inha University Hospital

Address:
City: Incheon
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea Incheon St.Mary's Hospital

Address:
City: Incheon
Country: Korea, Republic of

Facility:
Name: Pusan National University Hospital

Address:
City: Pusan
Country: Korea, Republic of

Facility:
Name: Korea University Anam Hospital

Address:
City: Seoul
Zip: 02841
Country: Korea, Republic of

Facility:
Name: The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Address:
City: Seoul
Zip: 03312
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Chung-Ang University Hospital

Address:
City: Seoul
Zip: 06973
Country: Korea, Republic of

Facility:
Name: Korea University Guro Hospital

Address:
City: Seoul
Zip: 08308
Country: Korea, Republic of

Facility:
Name: Severance Hospital, Yonsei University

Address:
City: Seoul
Zip: 120-752
Country: Korea, Republic of

Facility:
Name: The Catholic University Of Korea Seoul St. Mary's Hospital

Address:
City: Seoul
Zip: 137-701
Country: Korea, Republic of

Facility:
Name: Asan Medical Center, University of Ulsan

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Catholic Yeouido Sungmo Hospital

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Gangnam Severance Hospital

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Hallym UNIV. Medical Center

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Hanyang University Hospital

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Inje University Sanggye Paik Hospital

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Konkuk unversity hospital

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Kyunghee university hospital

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Soon Chun Hyang University Hospital Seoul

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Yongin Severance Hospital

Address:
City: Yongin
Country: Korea, Republic of

Start date: June 24, 2022

Completion date: December 31, 2026

Lead sponsor:
Agency: Yuhan Corporation
Agency class: Industry

Collaborator:
Agency: The Korean Academy of Tuberculosis and Respiratory Diseases
Agency class: Other

Source: Yuhan Corporation

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06247280

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