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

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Non-small Cell Lung Cancer (NSCLC)

Study type: Observational

Funder types: Other

Identifiers

NCT02380196

UPCC 02515

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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