Utility of CAML as Diagnostic for Early Stage Lung Cancer

Pulmonary Nodule, Solitary Clinical Trial

Official title:

TH-146: Cancer Associated Macrophage-Like (CAML) Cells to Enhance Detection of Early Stage Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03992183
• Other study ID #: TH-146
• Status: Active, not recruiting
• Start date: May 21, 2019
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule, Multiple
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Locations

Country	Name	City	State
United States	Corporal Michael J. Crescenz VA Medical Center	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	Creatv Microtech, Inc., United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of prevalence pf CAMLs in Pulmonary modules	Laboratory studies performed on blood drawn at Creatv Microtech will determine the prevalence of CAMLS in pulmonary nodules.	During the first 2 years of study
Secondary	Determination of positive and negative predictive value, sensitivity and specificity of CAMLS in patients with pulmonary nodules who undergo biopsy	Positive Predictive Value and Negative Predictive Value, sensitivity and specificity at the initial screen will be computed for the entire study population.	Through study completion, an average of 3 years
Secondary	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	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	Through study completion, a maximum of 3 years