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Korean Registry of Non-Small Cell Lung Cancer Patients with EGFR Mutation

NCT ID: NCT06247280

Last Updated: 2024-12-06

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

ACTIVE_NOT_RECRUITING

Total Enrollment

2001 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-24

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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NSCLC

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Korean Academy of Tuberculosis and Respiratory Diseases

OTHER

Sponsor Role collaborator

Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sae Young Lee

Role: STUDY_DIRECTOR

Yuhan Corporation

Locations

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Kyungpook National University Chilgok Hospital

Chilgok, Daegu, South Korea

Site Status

Hallym Univ. Medical Center. Chuncheon

Chuncheon, Gangwon-do, South Korea

Site Status

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, South Korea

Site Status

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

Uijeongbu-si, Gyeonggi-do, South Korea

Site Status

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

Bucheon-si, Gyeonggido, South Korea

Site Status

Wonkwang University Hospital

Iksan, Jeollabuk-do, South Korea

Site Status

Catholic Yeouido Sungmo Hospital

Seoul, Seoul, South Korea

Site Status

Inje University Haeundae Paik Hospital

Busan, , South Korea

Site Status

Kosin University Gospel Hospital

Busan, , South Korea

Site Status

Inje University Busan Paik Hospital

Busan, , South Korea

Site Status

Pusan National University Yangsan Hospital

Busan, , South Korea

Site Status

Samsung Changwon Hospital

Busan, , South Korea

Site Status

Changwon Gyeongsang National University Hospital

Changwon, , South Korea

Site Status

Yeungnam University Medical Center

Daegu, , South Korea

Site Status

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status

Keimyung University Dongsan Hospital

Daegu, , South Korea

Site Status

Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Konyang Univ. Hospital

Daejeon, , South Korea

Site Status

Cheonnam National University Hwasun Hospital

Hwasun, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

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

Incheon, , South Korea

Site Status

Pusan National University Hospital

Pusan, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

Asan Medical Center, University of Ulsan

Seoul, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Hallym UNIV. Medical Center

Seoul, , South Korea

Site Status

Hanyang University Hospital

Seoul, , South Korea

Site Status

Inje University Sanggye Paik Hospital

Seoul, , South Korea

Site Status

Konkuk unversity hospital

Seoul, , South Korea

Site Status

Kyunghee university hospital

Seoul, , South Korea

Site Status

Soon Chun Hyang University Hospital Seoul

Seoul, , South Korea

Site Status

Yongin Severance Hospital

Yŏngin, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YMC048

Identifier Type: -

Identifier Source: org_study_id