Clinical trial NCT03992183: Utility of CAML as Diagnostic for Early Stage Lung Cancer
Official title: TH-146: Cancer Associated Macrophage-Like (CAML) Cells to Enhance Detection of Early Stage Lung Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Nodule, Multiple
Pulmonary Nodule, Solitary
Keywords: CAML
Early Detection
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Creatv Microtech, Inc.
First posted: 2019-06-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be drawn from pulmonary nodule clinics at the Fox Chase Cancer Center and the VAMC Philadelphia

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


Eligibility criteria: 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.

Primary outcomes:
measure: Determination of prevalence pf CAMLs in Pulmonary modules
timeFrame: During the first 2 years of study
Secondary outcomes:
measure: Determination of positive and negative predictive value, sensitivity and specificity of CAMLS in patients with pulmonary nodules who undergo biopsy
timeFrame: Through study completion, an average of 3 years
measure: 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
timeFrame: Through study completion, a maximum of 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References: