Utility of CAML as Diagnostic for Early Stage Lung Cancer

NCT03992183 | Terminated

• 1 other identifier: TH-146
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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

Conditions

Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary

Keywords

CAML; Early Detection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Creatv Microtech, Inc.: collaborator
• United States Department of Defense: collaborator

Study Sites (2)

Corporal Michael J. Crescenz VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Two 10cc of blood per draw

MeSH Terms

Conditions

Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 20, 2019
• Study Start: May 21, 2019
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)