Pulmonary Nodule, MultipleNCT03992183
Utility of CAML as Diagnostic for Early Stage Lung Cancer
An observational study of Pulmonary Nodule, Multiple and Pulmonary Nodule, Solitary, run by Fox Chase Cancer Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule, Multiple, Pulmonary Nodule, Solitary
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 May 2019to 14 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be drawn from pulmonary nodule clinics at the Fox Chase Cancer Center and the VAMC Philadelphia
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: TH-146: Cancer Associated Macrophage-Like (CAML) Cells to Enhance Detection of Early Stage Lung Cancer
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
- Keywords
- CAML, Early Detection
- Medical subject headings
- Multiple Pulmonary Nodules, Solitary Pulmonary Nodule
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Positive Predictive Value and Negative Predictive Value, sensitivity and specificity at the initial screen will be computed for the entire study population.
Measured: 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
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
Measured: Through study completion, a maximum of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start21 May 2019
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, MultipleStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Creatv Microtech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992183
- Sponsor's protocol ID
- TH-146
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2019
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TH-146: Cancer Associated Macrophage-Like (CAML) Cells to Enhance Detection of Early Stage Lung Cancer
- ClinicalTrials.gov ID
- NCT03992183
- Acronym / sponsor ID
- TH-146
- Keywords
- CAML, Early Detection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense, Creatv Microtech, Inc.
- Study start
- 21 May 2019 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be drawn from pulmonary nodule clinics at the Fox Chase Cancer Center and the VAMC Philadelphia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of prevalence pf CAMLs in Pulmonary modules
Time frame: 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.
2 secondary outcomes
Determination of positive and negative predictive value, sensitivity and specificity of CAMLS in patients with pulmonary nodules who undergo biopsy
Time frame: 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
Time frame: Through study completion, a maximum of 3 years
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule, Multiple and Pulmonary Nodule, Solitary, run by Fox Chase Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of prevalence pf CAMLs in Pulmonary modules (time frame: During the first 2 years of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.