Utility of CAML as Diagnostic for Early Stage Lung Cancer

Active, not recruiting

• Conditions: Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary

• Registration Number: NCT03992183
• Lead Sponsor: Fox Chase Cancer Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-21
• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-20
• Primary Completion: 2022-11-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of prevalence pf CAMLs in Pulmonary modules	During the first 2 years of study	Laboratory studies performed on blood drawn at Creatv Microtech will determine the prevalence of CAMLS in pulmonary nodules.

Secondary Outcome Measures

Name	Time	Method
Determination of positive and negative predictive value, sensitivity and specificity of CAMLS in patients with pulmonary nodules who undergo biopsy	Through study completion, an average of 3 years	Positive Predictive Value and Negative Predictive Value, sensitivity and specificity at the initial screen will be computed for the entire study population.
Model combinations of clinical factors with the presence/absence of CAMLs to refine strategies for assessment of patients with pulmonary nodules. Evaluate whether measures result in enhanced T-cell activity/Natural Killer (NK) cell function and number	Through study completion, a maximum of 3 years	Bidimensional measurements of lung nodules done by a radiologist or pulmonary physician from CT scans with 5mm (or less) cuts, using lung windows in the axial plane

Trial Locations

Locations (2)

Corporal Michael J. Crescenz VA Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States