Non Small-cell Lung CancerNCT05462795
Liquid Biopsy for Early Non-small Lung Cancer Detection
An observational study of Non Small-cell Lung Cancer, run by University of Arizona at 1 site in United States.
Trial summary
This clinical trial will assess the performance of a liquid biopsy assay to identify cancer in indeterminant pulmonary nodules identified by CT screening of high-risk individuals and evaluate the capability of the liquid biopsy assay to monitor response to surgical resection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Small-cell Lung Cancer
- What is being tested?
- Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule, Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection and Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2022to 22 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and volunteers will be recruited from the BUMC-T Pulmonary and UACC clinics (Indeterminate pulmonary nodule); through study posting on ClinicalTrials.gov and word of mouth (Healthy volunteers); UACC Thoracic Surgery Clinic (Pre-post lung cancer surgery); and Pulmonary Clinic (Benign Lung Disease).
Who may be able to join
- Exclusion criteria: No known current cancer or history of cancer within 5 years
- Benign lung disease cohort
- Inclusion criteria: Patients with the following categories of benign lung disease: COPD/emphysema, Granulomatous infection, Interstitial lung disease including pulmonary fibrosis and interstitial lung disease.
Who cannot join
- Known lung cancer for surgical resection study cohort
- Inclusion criteria: Patients with known non-small cell lung cancer who will have surgical resection for treatment
- Healthy volunteer cohort
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Liquid Biopsy to Distinguish Malignant From Benign Pulmonary Nodules and to Monitor Response to Therapy
This clinical trial will assess the performance of a liquid biopsy assay to identify cancer in indeterminant pulmonary nodules identified by CT screening of high-risk individuals and evaluate the capability of the liquid biopsy assay to monitor response to surgical resection.
Read the detailed description
This clinical study examines the feasibility of a liquid biopsy methylation assay to detect non-small lung cancer. First, the investigators will apply their liquid biopsy assay to screen for lung cancer in indeterminate pulmonary nodules suspicious for cancer. Second, the investigators will assess the utility of liquid biopsy to assess tumor dynamics after surgical resection with curative intent. Third, the investigators will assess the presence or absence of this methylation assay in healthy normal persons without a history of lung cancer.
- Conditions
- Non Small-cell Lung Cancer
- Being tested
- Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule, Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection, Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer, Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease
- Keywords
- Lung cancer, Biomarker, DNA methylation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary noduleDiagnostic test
10 cc of blood is collected at one time point, which is prior to biopsy procedure
Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resectionDiagnostic test
10 cc of blood is collected at three time points: 1) before surgery; 2) 4-6 weeks post surgery; and 3) 6 months post surgery
Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteerDiagnostic test
10 cc of blood is collected at one time point
Liquid biopsy for aberrant DNA methylation analysis - Benign lung diseaseDiagnostic test
30 cc of blood is collected at one time point
| Study group | Role | What they receive |
|---|---|---|
| Indeterminate pulmonary nodule study cohort | Patients undergoing a biopsy of an indeterminate lung nodule by surgical excision, bronchoscopic biopsy or Interventional Radiology directed biopsy Receives: Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule | |
| Known lung cancer for surgical resection study cohort | Patients with known non-small cell lung cancer who will have surgical resection for treatment Receives: Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection | |
| Healthy volunteer cohort | Healthy volunteers with a) no current diagnosis of cancer; b) no history of cancer over the last 5 years; and c) no existing known benign lung disease that is currently requiring treatment with medication. Receives: Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer | |
| Benign lung disease cohort | Patients with the following categories of benign lung disease:
* COPD/emphysema
* Granulomatous infection
* Interstitial lung disease including pulmonary fibrosis and interstitial lung disease. Receives: Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indeterminate pulmonary nodule study cohort: Sensitivity and specificity of liquid biopsy test for malignancy
The patients with indeterminate nodules will be used to separately estimate the sensitivity (in those with lung cancer) and specificity (in those without lung cancer). At least 35 patients with lung cancer will provide an estimate of the standard error of the sensitivity < 0.09. Specificity will also be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals.
Measured: 9 months
Known lung cancer for surgical resection study cohort
To determine the correlation between the longitudinal marker levels and time to progression, to allow adjustment for relevant clinical characteristics.
Correlations between change in the methylation results and response to therapy using radiographic findings (response, stable disease, progression) at 6 months post-baseline time point will be analyzed using a multinomial regression model.
Measured: 9 months
Healthy volunteers study cohort
Specificity will be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals.
Measured: 9 months
Benign lung disease cohort
Thirty-five patients with benign lung disease will provide an estimate of the standard error of the specificity <0.09. Assuming a specificity value of 0.91 (32 negative/35 total), the exact 95% confidence interval is (0.77, 0.98). The specificity will be estimated separately, with an exact 95% confidence interval, for each of the benign lung disease subtypes as an exploratory analysis.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start2 Aug 2022
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Linda Garland, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462795
- Sponsor's protocol ID
- 2107020697
- Other IDs
- R43CA257133-01A1
- Status last verified
- Dec 2024
- First submitted
- 13 Jul 2022
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy to Distinguish Malignant From Benign Pulmonary Nodules and to Monitor Response to Therapy
- ClinicalTrials.gov ID
- NCT05462795
- Acronym / sponsor ID
- 2107020697
- Conditions
- Non Small-cell Lung Cancer
- Keywords
- Lung cancer, Biomarker, DNA methylation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 18 Jul 2022 (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 clinical trial will assess the performance of a liquid biopsy assay to identify cancer in indeterminant pulmonary nodules identified by CT screening of high-risk individuals and evaluate the capability of the liquid biopsy assay to monitor response to surgical resection.
Detailed description
This clinical study examines the feasibility of a liquid biopsy methylation assay to detect non-small lung cancer. First, the investigators will apply their liquid biopsy assay to screen for lung cancer in indeterminate pulmonary nodules suspicious for cancer. Second, the investigators will assess the utility of liquid biopsy to assess tumor dynamics after surgical resection with curative intent. Third, the investigators will assess the presence or absence of this methylation assay in healthy normal persons without a history of lung cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Indeterminate pulmonary nodule study cohort | – | Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodulePatients undergoing a biopsy of an indeterminate lung nodule by surgical excision, bronchoscopic biopsy or Interventional Radiology directed biopsy |
| Known lung cancer for surgical resection study cohort | – | Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resectionPatients with known non-small cell lung cancer who will have surgical resection for treatment |
| Healthy volunteer cohort | – | Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteerHealthy volunteers with a) no current diagnosis of cancer; b) no history of cancer over the last 5 years; and c) no existing known benign lung disease that is currently requiring treatment with medication. |
| Benign lung disease cohort | – | Diagnostic Test: Liquid biopsy for aberrant DNA methylation analysis - Benign lung diseasePatients with the following categories of benign lung disease: * COPD/emphysema * Granulomatous infection * Interstitial lung disease including pulmonary fibrosis and interstitial lung disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and volunteers will be recruited from the BUMC-T Pulmonary and UACC clinics (Indeterminate pulmonary nodule); through study posting on ClinicalTrials.gov and word of mouth (Healthy volunteers); UACC Thoracic Surgery Clinic (Pre-post lung cancer surgery); and Pulmonary Clinic (Benign Lung Disease).
Key inclusion criteria (3 listed)
- Exclusion criteria: No known current cancer or history of cancer within 5 years
- Benign lung disease cohort
- Inclusion criteria: Patients with the following categories of benign lung disease: COPD/emphysema, Granulomatous infection, Interstitial lung disease including pulmonary fibrosis and interstitial lung disease.
Key exclusion criteria (3 listed)
- Known lung cancer for surgical resection study cohort
- Inclusion criteria: Patients with known non-small cell lung cancer who will have surgical resection for treatment
- Healthy volunteer cohort
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 |
|---|---|---|
| Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule10 cc of blood is collected at one time point, which is prior to biopsy procedure | Diagnostic test | Indeterminate pulmonary nodule study cohort |
| Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection10 cc of blood is collected at three time points: 1) before surgery; 2) 4-6 weeks post surgery; and 3) 6 months post surgery | Diagnostic test | Known lung cancer for surgical resection study cohort |
| Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer10 cc of blood is collected at one time point | Diagnostic test | Healthy volunteer cohort |
| Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease30 cc of blood is collected at one time point | Diagnostic test | Benign lung disease cohort |
Primary outcome
Indeterminate pulmonary nodule study cohort: Sensitivity and specificity of liquid biopsy test for malignancy
Time frame: 9 months
The patients with indeterminate nodules will be used to separately estimate the sensitivity (in those with lung cancer) and specificity (in those without lung cancer). At least 35 patients with lung cancer will provide an estimate of the standard error of the sensitivity < 0.09. Specificity will also be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals.
Known lung cancer for surgical resection study cohort
Time frame: 9 months
To determine the correlation between the longitudinal marker levels and time to progression, to allow adjustment for relevant clinical characteristics. Correlations between change in the methylation results and response to therapy using radiographic findings (response, stable disease, progression) at 6 months post-baseline time point will be analyzed using a multinomial regression model.
Healthy volunteers study cohort
Time frame: 9 months
Specificity will be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals.
Benign lung disease cohort
Time frame: 9 months
Thirty-five patients with benign lung disease will provide an estimate of the standard error of the specificity <0.09. Assuming a specificity value of 0.91 (32 negative/35 total), the exact 95% confidence interval is (0.77, 0.98). The specificity will be estimated separately, with an exact 95% confidence interval, for each of the benign lung disease subtypes as an exploratory analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Non Small-cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Linda Garland, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small-cell Lung Cancer, run by University of Arizona at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Indeterminate pulmonary nodule study cohort: Sensitivity and specificity of liquid biopsy test for malignancy (time frame: 9 months). The study lists 4 primary outcomes in all. 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 16 Dec 2024.