Precancerous ConditionsNCT01752101
Identification of a Plasma Proteomic Signature for Lung Cancer
An observational study of Precancerous Conditions and Carcinoma, run by Integrated Diagnostics at 12 sites in United States.
Trial summary
The primary objective is to identify a panel of plasma and/or serum proteins that differentiates the absence or presence of lung malignancy in samples obtained from subjects enrolled in this IRB/EC approved study with pulmonary nodules. 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
- 475 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2012to Dec 2014
- 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: Patients undergoing procedure for histologic diagnosis of lung nodule(s)
Who may be able to join
- age ≥ 40
- any smoking status, e.g. current, former, or never
- co-morbid conditions, e.g. COPD
- Nodule size ≥ 4 mm and ≤ 30 mm (up to Stage 2B eligible), any spiculation or ground glass opacity
- Pathology: malignant - adenocarcinoma, squamous, or large cell
- Pathology: benign - inflammatory (e.g. granulomatous, infectious) or non-inflammatory (e.g. hamartoma)
Show all 9Show fewer
- Clinical stage, Primary tumor: ≤T2 (e.g. 1A, 1B, 2A and 2B)
- Clinical stage, Regional lymph nodes: N0 or N1 only
- Clinical stage, Distant metastasis: M0 only
Who cannot join
- prior malignancy within 5 years of lung nodule diagnosis
- No nodule size available
- No pathology data available for those with
- Current diagnosis of non-small cell lung cancer
- Clinical stage: Primary tumor ≥T3; Regional lymph nodes: ≥N2; 4 Distant metastasis: ≥M1
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
North East Alabama Regional Medical Center
Anniston, Georgia, 36207
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
University of Cincinnati
Cincinnati, Ohio, 45267
Cardiopulmonary Research Science and Technology Institute
Dallas, Texas, 75230
Geisinger Medical Center
Danville, Pennsylvania, 17822
Henry Ford Hospital
Detroit, Michigan, 48202
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Intermountain Healthcare
Murray, Utah, 84107
Mayo Clinic
Rochester, Minnesota, 55901
Kaiser Permanente Northern California
San Francisco, California, 94115
Group Health Research Institute
Seattle, Washington, 98101
About this study
The primary objective is to identify a panel of plasma and/or serum proteins that differentiates the absence or presence of lung malignancy in samples obtained from subjects enrolled in this IRB/EC approved study with pulmonary nodules.
Read the detailed description
Blood samples are obtained from those patients undergoing procedures to determine if a lung nodule is benign or cancerous. The data from the study will not be used to guide or influence the treatment of the patients enrolled in this study. There is no change from the normal standard of care that patients receive.
- 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 Non-Small Cell Lung Cancer
The incidence rate of non-small cell lung cancer in the study population will be correlated to the predictive value of the Sponsor's blood test.
Measured: 24 months after enrollment
Secondary outcomes (1)
Panel of proteins
The positive and negative predictive value of the test to differentiate between malignancy and inflammatory diseases such as granulomatous disorders.
Measured: At the end of the study
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 completionDec 2014
- Study completionDec 2014
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
- 475 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
- NCT01752101
- Sponsor's protocol ID
- 1013-12
- Status last verified
- Jan 2015
- First submitted
- 30 Nov 2012
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kearney P, Hunsucker SW, Li XJ, Porter A, Springmeyer S, Mazzone P. An integrated risk predictor for pulmonary nodules. PLoS One. 2017 May 17;12(5):e0177635. doi: 10.1371/journal.pone.0177635. eCollection 2017.
PubMed 28545097Vachani A, Hammoud Z, Springmeyer S, Cohen N, Nguyen D, Williamson C, Starnes S, Hunsucker S, Law S, Li XJ, Porter A, Kearney P. Clinical Utility of a Plasma Protein Classifier for Indeterminate Lung Nodules. Lung. 2015 Dec;193(6):1023-7. doi: 10.1007/s00408-015-9800-0. Epub 2015 Sep 16.
PubMed 26376647
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of a Plasma Proteomic Signature for Lung Cancer
- ClinicalTrials.gov ID
- NCT01752101
- Acronym / sponsor ID
- 1013-12
- Conditions
- Precancerous Conditions, Carcinoma
- Keywords
- Precancerous Conditions, Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Integrated DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (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.
The primary objective is to identify a panel of plasma and/or serum proteins that differentiates the absence or presence of lung malignancy in samples obtained from subjects enrolled in this IRB/EC approved study with pulmonary nodules.
Detailed description
Blood samples are obtained from those patients undergoing procedures to determine if a lung nodule is benign or cancerous. The data from the study will not be used to guide or influence the treatment of the patients enrolled in this study. There is no change from the normal standard of care that patients receive.
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
- Patients undergoing procedure for histologic diagnosis of lung nodule(s)
Key inclusion criteria (9 listed)
- age ≥ 40
- any smoking status, e.g. current, former, or never
- co-morbid conditions, e.g. COPD
- Nodule size ≥ 4 mm and ≤ 30 mm (up to Stage 2B eligible), any spiculation or ground glass opacity
- Pathology: malignant - adenocarcinoma, squamous, or large cell
Key exclusion criteria (5 listed)
- prior malignancy within 5 years of lung nodule diagnosis
- No nodule size available
- No pathology data available for those with
- Current diagnosis of non-small cell lung cancer
- Clinical stage: Primary tumor ≥T3; Regional lymph nodes: ≥N2; 4 Distant metastasis: ≥M1
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 Non-Small Cell Lung Cancer
Time frame: 24 months after enrollment
The incidence rate of non-small cell lung cancer in the study population will be correlated to the predictive value of the Sponsor's blood test.
1 secondary outcome
Panel of proteins
Time frame: At the end of the study
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 9 Jan 2015.
- Derived from this study: PubMed 28545097Kearney P, Hunsucker SW, Li XJ, Porter A, Springmeyer S, Mazzone P. An integrated risk predictor for pulmonary nodules. PLoS One. 2017 May 17;12(5):e0177635. doi: 10.1371/journal.pone.0177635. eCollection 2017.
- Derived from this study: PubMed 26376647Vachani A, Hammoud Z, Springmeyer S, Cohen N, Nguyen D, Williamson C, Starnes S, Hunsucker S, Law S, Li XJ, Porter A, Kearney P. Clinical Utility of a Plasma Protein Classifier for Indeterminate Lung Nodules. Lung. 2015 Dec;193(6):1023-7. doi: 10.1007/s00408-015-9800-0. Epub 2015 Sep 16.
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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.
12 sites in 1 country: 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 12 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 9 inclusion and 5 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 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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 Non-Small Cell Lung Cancer (time frame: 24 months after 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 NCT01752101, 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 9 Jan 2015.