TerminatedNot applicableNCT03553550
Official study title

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

Study summary

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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedbiospecimen collection

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 19, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Addario Lung Cancer Medical Institute

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Addario Lung Cancer Medical Institute
Interventions being studied
Other: biospecimen collection
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Male or female aged 18 years and over 2. Planned surgical resection of NSCLC, stage IB ≥ 4 cm, II or IIIA according to the 8th edition of TNM classification16. 1. 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. 2. 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. 3. 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. 3. Patients with positive margins and those requiring adjuvant radiation therapy are eligible. 4. Patients with a secondary malignancy that was treated with curative intent and without evidence of relapse for at least 5 years. 5. Willingness to undergo all study collection procedures and follow up. 6. Provision of written informed consent

Reasons someone may not be able to joinExclusion criteria

1. Male or female aged less than 18 years 2. NSCLC disease other than stated above 3. Patients with a secondary malignancy that was not treated with curative intent or has had a disease relapse in the past 5 years. 4. Unwilling to undergo all study collection procedures and follow up. 5. Unable or unwilling to provide consent.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Northside HospitalAtlanta, Georgia
  • Rush University Medical CenterChicago, Illinois
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • St. Louis Cancer CareBridgeton, Missouri
  • Washington University School of MedicineSt Louis, Missouri
  • Vanderbilt University Medical CenterNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 19, 2020. Always confirm current availability with the study team.

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