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

Completed

• Conditions: Non-small Cell Lung Cancer (NSCLC)

• Registration Number: NCT02380196
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-05
• Status Verified: 2019-07
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 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
2. 18 years of age
3. Ability to read and sign informed consent
4. Both men and women and members of all races and ethnic groups are eligible for this trial.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of adverse events	2.5 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States