Cell Free DNA for the Diagnosis and Treatment in Early NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

Prospective Feasibility Study of Cell Free Circulating Tumor DNA for the Diagnosis and Treatment Monitoring in Early-stage Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03791034
• Other study ID #: 2017-08-041-003
• Status: Recruiting
• Start date: August 28, 2017
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2021
• Source: Samsung Medical Center
• Contact: Jhingook Kim, MD
• Phone: +82-2-3410-3483
• Email: jkimsmc[@]skku.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

During evolution of primary tumor, tumor cells can be released into the bloodstream. It has also been shown that circulating cell-free tumor DNA (cfDNA) is released from apoptotic or necrotic tumor cells. In a study of cfDNA level after surgery in colon cancer patients, they suggested that cfDNA could detect recurrence of cancer several months earlier than the conventional follow up studies. Following several reports have suggested that cfDNA can invade host cells and alter host cell biology to cause cancer metastasis.

In this regard, we will collect from non-small cell lung cancer patients cohort who underwent curative resection, and will evaluate whether peripheral cfDNA can aid early detection of cancer recurrence. We will also study the genomic signature of cfDNA to assess the relationship between cfDNA and clinical outcome of non-small cell lung cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Guardant Health, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Recurrence of primary tumor documented by diagnostic imaging with or without biopsy	24 months