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OpenTrials
Completed

NCT Number: NCT02380196

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of adverse events

    Time frame: 2.5 years

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2015
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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