Role of Circulating Tumor DNA (ctDNA) From LIquid Biopsy in Early Stage NSCLC Resected Lung Tumor Investigation

Stopped early

Conditions studied: Non Small Cell Lung Cancer

In brief

The purpose of this research study is to learn more about changes in cell-free tumor DNA in blood samples, also known as a liquid biopsy, as they relate to treatment and response to treatment.

Key facts

Study ID

NCT03553550

Run by

Addario Lung Cancer Medical Institute

People needed

38

Starts

2018-06-01

Expected to finish

2020-11-15

Last updated by the study team

2020-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged 18 years and over
• Planned surgical resection of NSCLC, stage IB ≥ 4 cm, II or IIIA according to the 8th edition of TNM classification16.
• Cohort #1: Neoadjuvant Therapy - For patients who will receive neoadjuvant therapy, enrollment occurs prior to the initiation of treatment. Patients undergoing neoadjuvant therapy who achieved tumor reduction, are eligible based on baseline radiographic staging.
• Cohort #2: Pre-Surgery - For patients identified prior to planned surgical resection, enrollment occurs within 30 days of the planned surgery. Eligibility is based on surgical pathology.
• Cohort #3: Post-Surgery - For patients identified post-surgical resection, enrollment occurs prior to the initiation of adjuvant therapy. Eligibility is based on surgical pathology.
• Patients with positive margins and those requiring adjuvant radiation therapy are eligible.
• Patients with a secondary malignancy that was treated with curative intent and without evidence of relapse for at least 5 years.
• Willingness to undergo all study collection procedures and follow up.
• Provision of written informed consent

You may not qualify if…

• Male or female aged less than 18 years
• NSCLC disease other than stated above
• Patients with a secondary malignancy that was not treated with curative intent or has had a disease relapse in the past 5 years.
• Unwilling to undergo all study collection procedures and follow up.
• Unable or unwilling to provide consent.

Where it is running

• Northside Hospital — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• St. Louis Cancer Care — Bridgeton, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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