Utility of CAML as Diagnostic for Early Stage Lung Cancer | NCT03992183

Studies
Utility of CAML as Diagnostic for Early Stage Lung Cancer

NCT03992183

Sponsor

Fox Chase Cancer Center

Status

Terminated

Last Update Posted

Mar 4, 2026Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Pulmonary Nodule, Multiple
Pulmonary Nodule, Solitary

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow accrual

Expanded Access Info

Start Date

May 21, 2019Actual

Primary Completion Date

Nov 14, 2022Actual

Completion Date

Nov 14, 2022Actual

First Submitted Date

Jun 13, 2019

First Submission Date that Met QC Criteria

Jun 17, 2019

First Posted Date

Jun 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2026

Last Update Posted Date

Mar 4, 2026Actual

Name	Class
United States Department of Defense	FED
Creatv Microtech, Inc.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects will be drawn from pulmonary nodule clinics at the Fox Chase Cancer Center and the VAMC Philadelphia

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Corporal Michael J. Crescenz VA Medical Center		Philadelphia	Pennsylvania	19104	United States
Fox Chase Cancer Center

ID	Term
D055613	Multiple Pulmonary Nodules
D003074	Solitary Pulmonary Nodule

ID	Term
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site