Utility of CAML as Diagnostic for Early Stage Lung Cancer

Temple University Health System (TUHS)

Status: Active, not recruiting

Conditions: Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03992183

TH-146

Details and patient eligibility

About

Primary Objective Determine the prevalence of CAMLS in patients with pulmonary nodules.

Secondary Objectives Determine the positive and negative predictive value of CAMLS in patients with pulmonary nodules who undergo biopsy.

Model combinations of clinical factors with the presence/absence of CAMLS to refine strategies for assessment of patients with pulmonary nodules. Evaluate whether these measures result in enhanced T-cell activity and/or NK cell function and number

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Referral for a pulmonary nodule that has not yet been biopsied and that meets the definition of an "indeterminate" nodules (i.e. 0.8-3.0 cm).
• No prior diagnosis of lung cancer or other invasive malignancy within the past 5 years.
• No history of rheumatologic disease.
• Age > 18 years.
• Ability to understand and willingness to sign a written informed consent and HIPAA consent document

Exclusion criteria

• Patients with active, known or suspected autoimmune disease.
• Prior diagnosis of lung cancer or other invasive malignancy within the past 5 years.
• Uncontrolled intercurrent illness that would increase the risk of toxicity or limit compliance with study requirements. This includes but is not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the abnormal immune response that results from HIV disease (testing is not required).
• Patients should be excluded if they are known to be positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection (testing is not required).
• Subjects with any history of interstitial lung disease or a history of > or = to grade 2 radiation pneumonitis.

Trial design