The Utility of Circulating Tumor Cells as Confirmation of Pathologic Diagnosis in Patients With Suspected Early Stage Non-small Cell Lung Cancer

April 13, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

The primary objective of this study is to determine whether circulating tumor cells (CTCs) can be used as a non-invasive means of confirming pathologic diagnosis in early-stage (Stage I) non-small cell lung cancer (NSCLC). Patients scheduled to undergo surgical intervention will have blood samples obtained to test for CTCs. Presence of CTCs will be compared to final pathologic diagnosis based on surgical specimens to assess the sensitivity of using CTCs alone to make a definitive diagnosis.

Study Overview

Status

Completed

Conditions

Non-small Cell Lung Cancer (NSCLC)

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Non-small cell lung cancer (NSCLC)

Description

Inclusion Criteria:

Clinical diagnosis of stage I NSCLC a. Only patients with a pathologically confirmed NSCLC will be retained for data analysis b. Should pathologic diagnosis reveal a more advanced stage, these subjects will remain in the study
18 years of age
Ability to read and sign informed consent
Both men and women and members of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

Prior cancer diagnosis, excluding previously treated non-melanoma skin cancer
Prior or ongoing treatment of the clinically diagnosed cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events Time Frame: 2.5 years	2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

Principal Investigator: Charles Simone, MD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria