Pilot Study of High Risk Lung Cancer Screening

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Lung Cancer

Treatments

Diagnostic Test: Screening

Study type

Interventional

Funder types

Other

Identifiers

NCT03683940

15-1694.cc

Details and patient eligibility

About

This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines.

Full description

This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines. Potential subject's 6 yr lung cancer risk must exceed 1.5% by the Tammamagi PLCO2012m calculator. Patients will undergo a non contrast CT chest for lung cancer screening. This cutoff should encompass in excess of 80% of all lung cancer cases (10). However, in patients 78-82 years old we will set the 6 yr lung cancer risk threshold at 4.0% as these patients will typically have other competing risks of death and this may potentially limit screening benefit in these older individuals.

Enrollment

48 patients

Sex

All

Ages

40 to 82 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult 40-82 yrs of age.
Presenting for lung cancer screening evaluation.
Calculated 6 yr lung cancer risk >1.5% for patients 40-77 years of age or >4% for patients 78-82 years of age.
Able and willing to provide informed consent.

Exclusion criteria

Eligible for clinically indicated lung cancer screening (55-80 yr old, >30 pky smoking history, still smoking or quit smoking within the last 15 yr).
Chest CT performed within the last year.
Life expectancy less than 6 months.
Symptoms clinically consistent with lung cancer.
Unable or unwilling to undergo treatment for lung cancer.
Any individual who does not give oral and written consent for participation.