Precancerous ConditionsNCT01752114
Early Diagnosis of Pulmonary Nodules
An observational study of Precancerous Conditions and Carcinoma, run by Integrated Diagnostics at 33 sites in 2 countries.
Trial summary
This study is intended to determine the positive predictive value (PPV) and negative predictive value (NPV) of the multiprotein classifier based on the observed study prevalence of Non-Small Cell Lung Cancer (NSCLC) in the study participants. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Precancerous Conditions, Carcinoma
- How many people
- 684 participants
- Where
- 33 sitesin 2 countries
- Study dates
- Oct 2012to 31 Dec 2016
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subject undergoing evaluation for a lung nodule by a pulmonologist in a pulmonary or chest clinic, and/or by a thoracic surgeon at the time of enrollment
Who may be able to join
- Age ≥ 40 years
- Smoking history: Never, Former, Current
- Subject undergoing diagnostic evaluation for a lung nodule
- Subject undergoing evaluation for a lung nodule by a pulmonologist, and/or by a thoracic surgeon
- Baseline CT scan identifying lung nodule performed within 60 days of subject enrollment
- Nodule(s) identified by CT scan previously not followed
- Subject willing to provide informed consent for the collection of blood specimens
Who cannot join
- Nodule work-up at the time of enrollment eligibility indicates any prior attempted or completed diagnostic biopsy procedure, such as transthoracic needle aspiration, bronchoscopic biopsy or surgery
- A prior CT scan is available that previously identifies the same lung nodule under consideration for study inclusion on the most current CT scan; AND the prior CT scan was performed more than 60 days before the current CT scan, irrespective of the candidate nodule's radiographic characterization such as size, density or appearance
- Current diagnosis of any cancer
- Prior diagnosis of any cancer within 2 years of lung nodule detection, except for non-melanoma skin cancer
- Administration of blood products, e.g. packed red blood cells, fresh frozen plasma, or platelets, within 30 days of subject enrollment
- History of human immunodeficiency virus (HIV) or Hepatitis C
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States31 sites
Georgia Lung Associates
Austell, Georgia, 30106
Pulmonary & Crit Care Associates of Baltimore
Baltimore, Maryland, 21237
Johns Hopkins Medical Center
Baltimore, Maryland, 21287
Charleston Research Institute
Charleston, North Carolina, 29403
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolinas HealthCare System
Charlotte, North Carolina, 28203
St. Luke's Medical Center
Chesterfield, Missouri, 63017
Cleveland Clinic
Cleveland, Ohio, 44195
Geisinger Medical Center
Danville, Pennsylvania, 17822
Henry Ford Hospital
Detroit, Michigan, 48202
Suburban Lung Associates
Elk Grove Village, Illinois, 60007
Inova Healthcare
Fairfax, Virginia, 22042
LeBaurer Healthcare
Greensboro, North Carolina, 27403
University of Southern California
Los Angeles, California, 90089
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202
Virginia Piper Cancer Institute - Allina Health
Minneapolis, Minnesota, 55407
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212
New York University Clinical Cancer Center
New York, New York, 10016
University of Pennsylvania
Philadelphia, Pennsylvania, 10104
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Oregon Clinic
Portland, Oregon, 97220
Mayo Clinic
Rochester, Minnesota, 55901
Beaumont Health System
Royal Oak, Michigan, 48703
California Pacific Medical Center
San Francisco, California, 94115
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Baystate Health
Springfield, Massachusetts, 01199
Scott & White Clinic
Temple, Texas, 76508
Pulmonary Associates of Southern Arizona
Tucson, Arizona, 85712
Salem Chest Specialists
Winston-Salem, North Carolina, 27103
Canada2 sites
Institute Universitarie de Cardiologie et de Pneumologie
Québec, Quebec, G1V 4G5
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G2C4
About this study
Official title: Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12
This study is intended to determine the positive predictive value (PPV) and negative predictive value (NPV) of the multiprotein classifier based on the observed study prevalence of Non-Small Cell Lung Cancer (NSCLC) in the study participants.
Read the detailed description
Patients must present with previously non-diagnosed lung nodules as found on CT. There is no change to the typical standard of care that any of the investigating physicians and/or centers provide the patients enrolled in this study. The data from this study will not be used to diagnose cancer nor be used to influence treatment decisions for the study participants.
- Conditions
- Precancerous Conditions, Carcinoma
- Keywords
- Precancerous conditions, Carcinoma
- Medical subject headings
- Precancerous Conditions, Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer
Incidence rate of Non-Small Cell Lung Cancer as determined by histologic or cytologic diagnosis and/or radiographically stability at 2 years post enrollment.
Measured: 2 years post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startOct 2012
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Precancerous ConditionsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrated Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell F. Hudnall, Study director, Integrated Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752114
- Sponsor's protocol ID
- PANOPTIC (1001-12)
- Status last verified
- Aug 2016
- First submitted
- 30 Nov 2012
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Long KJ, Silvestri GA, Kammer MN, Gibbs S, Wu W, Johal M, Pipavath S, Pitcher T, Jett J, Nair VS. Validation of a High-Specificity Blood Autoantibody Test to Detect Lung Cancer in Pulmonary Nodules. CHEST Pulm. 2025 Mar;3(1):100130. doi: 10.1016/j.chpulm.2024.100130. Epub 2024 Dec 25.
PubMed 40296864Silvestri GA, Tanner NT, Kearney P, Vachani A, Massion PP, Porter A, Springmeyer SC, Fang KC, Midthun D, Mazzone PJ; PANOPTIC Trial Team. Assessment of Plasma Proteomics Biomarker's Ability to Distinguish Benign From Malignant Lung Nodules: Results of the PANOPTIC (Pulmonary Nodule Plasma Proteomic Classifier) Trial. Chest. 2018 Sep;154(3):491-500. doi: 10.1016/j.chest.2018.02.012. Epub 2018 Mar 1.
PubMed 29496499
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12
- ClinicalTrials.gov ID
- NCT01752114
- Acronym / sponsor ID
- PANOPTIC (1001-12)
- Conditions
- Precancerous Conditions, Carcinoma
- Keywords
- Precancerous conditions, Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- Integrated DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 19 Dec 2012 (estimated)
- 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 study is intended to determine the positive predictive value (PPV) and negative predictive value (NPV) of the multiprotein classifier based on the observed study prevalence of Non-Small Cell Lung Cancer (NSCLC) in the study participants.
Detailed description
Patients must present with previously non-diagnosed lung nodules as found on CT. There is no change to the typical standard of care that any of the investigating physicians and/or centers provide the patients enrolled in this study. The data from this study will not be used to diagnose cancer nor be used to influence treatment decisions for the study participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subject undergoing evaluation for a lung nodule by a pulmonologist in a pulmonary or chest clinic, and/or by a thoracic surgeon at the time of enrollment
Key inclusion criteria (7 listed)
- Age ≥ 40 years
- Smoking history: Never, Former, Current
- Subject undergoing diagnostic evaluation for a lung nodule
- Subject undergoing evaluation for a lung nodule by a pulmonologist, and/or by a thoracic surgeon
- Baseline CT scan identifying lung nodule performed within 60 days of subject enrollment
Key exclusion criteria (6 listed)
- Nodule work-up at the time of enrollment eligibility indicates any prior attempted or completed diagnostic biopsy procedure, such as transthoracic needle aspiration, bronchoscopic biopsy or surgery
- A prior CT scan is available that previously identifies the same lung nodule under consideration for study inclusion on the most current CT scan; AND the prior CT scan was performed more than 60 days before the current CT scan, irrespective of the candidate nodule's radiographic characterization such as size, density or appearance
- Current diagnosis of any cancer
- Prior diagnosis of any cancer within 2 years of lung nodule detection, except for non-melanoma skin cancer
- Administration of blood products, e.g. packed red blood cells, fresh frozen plasma, or platelets, within 30 days of subject enrollment
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
Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer
Time frame: 2 years post enrollment
Incidence rate of Non-Small Cell Lung Cancer as determined by histologic or cytologic diagnosis and/or radiographically stability at 2 years post enrollment.
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 1 Mar 2018.
- Derived from this study: PubMed 40296864Long KJ, Silvestri GA, Kammer MN, Gibbs S, Wu W, Johal M, Pipavath S, Pitcher T, Jett J, Nair VS. Validation of a High-Specificity Blood Autoantibody Test to Detect Lung Cancer in Pulmonary Nodules. CHEST Pulm. 2025 Mar;3(1):100130. doi: 10.1016/j.chpulm.2024.100130. Epub 2024 Dec 25.
- Derived from this study: PubMed 29496499Silvestri GA, Tanner NT, Kearney P, Vachani A, Massion PP, Porter A, Springmeyer SC, Fang KC, Midthun D, Mazzone PJ; PANOPTIC Trial Team. Assessment of Plasma Proteomics Biomarker's Ability to Distinguish Benign From Malignant Lung Nodules: Results of the PANOPTIC (Pulmonary Nodule Plasma Proteomic Classifier) Trial. Chest. 2018 Sep;154(3):491-500. doi: 10.1016/j.chest.2018.02.012. Epub 2018 Mar 1.
- 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.
Russell F. Hudnall study director
Integrated Diagnostics, Inc.
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Precancerous Conditions and Carcinoma, run by Integrated Diagnostics at 33 sites in 2 countries.
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 7 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: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Canada. 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?
Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer (time frame: 2 years post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01752114, which also lists 2 linked publications.
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 1 Mar 2018.