NCT04922073

Brief Summary

The aim of the study is to assess the practical usability of EGFR mutation detection in ctDNA from early NSCLC.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

May 26, 2021

Last Update Submit

August 23, 2021

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Performance of the EGFR assay

    ADPS EGFR Mutation Test using plasma sample from clinical stage IB-IIIA NSCLC patients (reference: EGFR assay in tissue specimen)

    Immediately before the surgery

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with clinical stage IB to IIIA Non-small Cell Lung Cancer

You may qualify if:

  • Patient with clinical stage IB to IIIA Non-small Cell Lung Cancer
  • Patients with resectable lung cancer
  • One of followings: 1) Never-smokers or ex-smokers who quit 10 years ago, 2) Female 3) Subsolid nodule in chest CT 4) Biopsy-proven adenocarcinoma

You may not qualify if:

  • Patients with metastatic lung cancer (Stage IIIB-IV)
  • Patients who underwent chemotherapy or radiotherapy
  • Patients with other malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

circulating tumor DNA in plasma

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Jhingook Kim, MD

CONTACT

82-2-3410-1696jhingookkim@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 26, 2021

First Posted

June 10, 2021

Study Start

June 1, 2021

Primary Completion

January 31, 2022

Study Completion

March 31, 2022

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations

KR(1)