NCT03479099

Brief Summary

The purpose of this study is to assess clinical utility of combined circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) in the diagnosis of primary lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 12, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

March 12, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

12 months

First QC Date

March 12, 2018

Last Update Submit

August 24, 2019

Conditions

Lung Cancer (Diagnosis)Circulating Tumor Cell

Keywords

Lung cancerCirculating Tumor CellCell-Free Tumor DNALiquid Biopsy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic sensitivity of combined CTC and ctDNA

    To compared the sensitivity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer

    1 year

Secondary Outcomes (2)

  • Diagnostic accuracy of combined CTC and ctDNA

    1 year

  • Diagnostic specificity of CTC and ctDNA

    1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The subjects who are referred for the evaluation and management of primary lung cancer in the tertiary care center

You may qualify if:

  • Patients with histology-proven lung cancer or a clinical suspicion of lung cancer
  • Age \>=18, \< 80 years
  • No previous history of cancer treatment within 5 years
  • Patients who agree to participate

You may not qualify if:

  • Patients who have been diagnosed with malignancy within 5 years
  • Patients with previous history of lung cancer
  • Patients who have uncontrolled coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06278, South Korea

Location

Related Publications (1)

  • Moon SM, Kim JH, Kim SK, Kim S, Kwon HJ, Bae JS, Lee S, Lee HS, Choi MY, Jeon BH, Jeong BH, Lee K, Kim HK, Kim J, Um SW. Clinical Utility of Combined Circulating Tumor Cell and Circulating Tumor DNA Assays for Diagnosis of Primary Lung Cancer. Anticancer Res. 2020 Jun;40(6):3435-3444. doi: 10.21873/anticanres.14329.

    PMID: 32487642DERIVED

MeSH Terms

Conditions

Lung NeoplasmsDiseaseNeoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasm MetastasisNeoplastic Processes

Study Design

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

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 27, 2018

Study Start

March 12, 2018

Primary Completion

March 11, 2019

Study Completion

March 11, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)