Lung CarcinomaNCT04162678
Fluid Biopsy for the Diagnosis of Lung Cancer
An observational study of Lung Carcinoma, run by University of Southern California at 2 sites in United States.
Trial summary
This trial collects and studies blood samples via fluid biopsy for the diagnosis of lung cancer. Studying blood samples in the laboratory may help doctors develop a blood test for lung cancer in the future and provide a better way to screen patients for lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Biospecimen Collection, Laboratory Biomarker Analysis and Liquid Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2020to 9 Dec 2024
- 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: Patients undergoing a biopsy or CT screening for lung cancer
Who may be able to join
- Scheduled to undergo a diagnostic biopsy for possible lung cancer or
- Completed a diagnostic lung cancer biopsy in the prior 2 weeks and has not yet undergone treatment or
- Planning or completed in the last 2 weeks a CT lung cancer screen
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- Known other solid tumor malignancy other than lung cancer requiring ongoing active treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Los Angeles County-USC Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Establishing a Diagnosis of Lung Cancer Through a Fluid Biopsy
This trial collects and studies blood samples via fluid biopsy for the diagnosis of lung cancer. Studying blood samples in the laboratory may help doctors develop a blood test for lung cancer in the future and provide a better way to screen patients for lung cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To estimate the sensitivity and specificity of the fluid biopsy in establishing a diagnosis of bronchogenic carcinoma.
SECONDARY OBJECTIVES:
- To determine the accuracy of determination of the histologic subtype of bronchogenic lung cancer.
II. To determine the relative contribution of cell based high definition circulating tumor cell assay (HD-CTC) and imaging mass cytometry (IMC) and plasma based circulating tumor deoxyribonucleic acid (ctDNA) assays in determination of diagnosis and histologic subtype.
OUTLINE:
Patients undergo collection of blood samples on day 1 for analysis via high definition (HD)-single cell analysis (SCA) fluid biopsy. Medical charts of patients are reviewed at 3 months post-biopsy or computed tomography (CT) screening.
After completion of study, patients are followed for up to 1 year.
- Conditions
- Lung Carcinoma
- Being tested
- Biospecimen Collection, Laboratory Biomarker Analysis, Liquid Biopsy, Medical Chart Review
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood via HD-SCA fluid biopsy
Laboratory Biomarker AnalysisOther
Correlative studies
Liquid BiopsyProcedure or surgery
Also called Plasma Biopsy
Undergo collection of blood via HD-SCA fluid biopsy
Medical Chart ReviewOther
Also called Chart Review
Review of medical chart
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (blood collection via fluid biopsy, lab analysis) | Patients undergo collection of blood samples on day 1 for analysis via HD-SCA fluid biopsy. Medical charts of patients are reviewed at 3 months post-biopsy or CT screening. Receives: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Procedure: Liquid Biopsy; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical diagnosis of lung cancer
Descriptive statistics including sensitivity, specificity, positive, and negative predictive value will be tabulated.
Measured: Within 90 days of tissue biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start13 Jan 2020
- Primary completion5 Dec 2024
- Study completion9 Dec 2024
Why it stopped: insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jorge J Nieva, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162678
- Sponsor's protocol ID
- 2N-19-3
- Other IDs
- NCI-2019-05861, 2N-19-3, P30CA014089
- Status last verified
- Aug 2025
- First submitted
- 11 Nov 2019
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Diagnosis of Lung Cancer Through a Fluid Biopsy
- ClinicalTrials.gov ID
- NCT04162678
- Acronym / sponsor ID
- 2N-19-3
- Conditions
- Lung Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient accrual
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 14 Nov 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.
This trial collects and studies blood samples via fluid biopsy for the diagnosis of lung cancer. Studying blood samples in the laboratory may help doctors develop a blood test for lung cancer in the future and provide a better way to screen patients for lung cancer.
Detailed description
PRIMARY OBJECTIVE:
- To estimate the sensitivity and specificity of the fluid biopsy in establishing a diagnosis of bronchogenic carcinoma.
SECONDARY OBJECTIVES:
- To determine the accuracy of determination of the histologic subtype of bronchogenic lung cancer.
II. To determine the relative contribution of cell based high definition circulating tumor cell assay (HD-CTC) and imaging mass cytometry (IMC) and plasma based circulating tumor deoxyribonucleic acid (ctDNA) assays in determination of diagnosis and histologic subtype.
OUTLINE:
Patients undergo collection of blood samples on day 1 for analysis via high definition (HD)-single cell analysis (SCA) fluid biopsy. Medical charts of patients are reviewed at 3 months post-biopsy or computed tomography (CT) screening.
After completion of study, patients are followed for up to 1 year.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (blood collection via fluid biopsy, lab analysis) | – | Procedure: Biospecimen Collection, Other: Laboratory Biomarker Analysis, Procedure: Liquid Biopsy, Other: Medical Chart ReviewPatients undergo collection of blood samples on day 1 for analysis via HD-SCA fluid biopsy. Medical charts of patients are reviewed at 3 months post-biopsy or CT screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a biopsy or CT screening for lung cancer
Key inclusion criteria (4 listed)
- Scheduled to undergo a diagnostic biopsy for possible lung cancer or
- Completed a diagnostic lung cancer biopsy in the prior 2 weeks and has not yet undergone treatment or
- Planning or completed in the last 2 weeks a CT lung cancer screen
- Ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (2 listed)
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- Known other solid tumor malignancy other than lung cancer requiring ongoing active treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood via HD-SCA fluid biopsy | Procedure or surgery | Diagnostic (blood collection via fluid biopsy, lab analysis) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (blood collection via fluid biopsy, lab analysis) |
| Liquid BiopsyAlso: Plasma BiopsyUndergo collection of blood via HD-SCA fluid biopsy | Procedure or surgery | Diagnostic (blood collection via fluid biopsy, lab analysis) |
| Medical Chart ReviewAlso: Chart ReviewReview of medical chart | Other | Diagnostic (blood collection via fluid biopsy, lab analysis) |
Primary outcome
Clinical diagnosis of lung cancer
Time frame: Within 90 days of tissue biopsy
Descriptive statistics including sensitivity, specificity, positive, and negative predictive value will be tabulated.
Results and safety
The study was stopped early (reason given: insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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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.
Jorge J Nieva, MD principal investigator
University of Southern California
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 Lung Carcinoma, run by University of Southern California 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 4 inclusion and 2 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 5 Sep 2025. 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: insufficient 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?
Clinical diagnosis of lung cancer (time frame: Within 90 days of tissue biopsy). 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 5 Sep 2025.