NCT03791034

Brief Summary

The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA (cfDNA) can aid screening of recurrence after complete resection of early stage non-small cell lung cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress94%
Aug 2017Dec 2026

Study Start

First participant enrolled

August 28, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

4.3 years

First QC Date

December 29, 2018

Last Update Submit

May 9, 2021

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancerRecurrencecfDNA

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Recurrence of primary tumor documented by diagnostic imaging with or without biopsy

    24 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

non-small cell lung cancer patients who undergone curative surgery

You may qualify if:

  • All subjects need to sign the informed consent form
  • All subjects have Non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively.
  • Non-small cell lung cancer have to confirmed pathologically after operation
  • Clinical stage I - IIIA by AJCC 7th staging system

You may not qualify if:

  • Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer
  • Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix with 3 years before enrollment
  • Recurrent lung cancer
  • Stage IIIB, IV by AJCC 7th staging system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will collect peripheral blood cell-free tumor DNA serially in non-small cell lung cancer cancer patients.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungRecurrence

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jhingook Kim, MD

    Samsung Medical Center

    STUDY CHAIR

Central Study Contacts

Jhingook Kim, MD

CONTACT

+82-2-3410-3483jkimsmc@skku.edu

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

December 29, 2018

First Posted

January 2, 2019

Study Start

August 28, 2017

Primary Completion

December 31, 2021

Study Completion (Estimated)

December 31, 2026

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)