Liquid Biopsy in Lung Cancer

Circulating Tumor Cell Clinical Trial

Official title:

Clinical Utility of Combined CTC and ctDNA Assay in the Diagnosis of Primary Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479099
• Other study ID #: 2018-01-081
• Status: Completed
• Start date: March 12, 2018
• Est. completion date: March 11, 2019

Study information

• Verified date: August 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The peripheral blood and tumor tissue samples are collected from the participants.CTC and ctDNA are analyzed from the blood samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 11, 2019
• Est. primary completion date: March 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients who have been diagnosed with malignancy within 5 years

• Patients with previous history of lung cancer

• Patients who have uncontrolled coagulopathy

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Lung Cancer (Diagnosis)
• Lung Neoplasms
• Neoplasms
• Neoplastic Cells, Circulating

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnostic accuracy of combined CTC and ctDNA	To compared the accuracy of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer	1 year
Secondary	Diagnostic specificity of CTC and ctDNA	To compared the specificity of combined CTC and ctDNA with those of CTC and ctDNA alone in diagnosis of primary lung cancer	1 year