Early Diagnosis of Pulmonary Nodules
This study is ongoing, but not recruiting participants.
Sponsor:
Integrated Diagnostics
Information provided by (Responsible Party):
Integrated Diagnostics
ClinicalTrials.gov Identifier:
NCT01752114
First received: November 30, 2012
Last updated: August 29, 2016
Last verified: August 2016
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Purpose
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.
| Condition |
|---|
|
Precancerous Conditions Carcinoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12 |
Resource links provided by NLM:
Further study details as provided by Integrated Diagnostics:
Primary Outcome Measures:
- Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer [ Time Frame: 2 years post enrollment ] [ Designated as safety issue: No ]Incidence rate of Non-Small Cell Lung Cancer as determined by histologic or cytologic diagnosis and/or radiographically stability at 2 years post enrollment.
Biospecimen Retention: Samples With DNA
Blood samples
| Enrollment: | 684 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752114
Show 33 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752114
Show 33 Study Locations
Sponsors and Collaborators
Integrated Diagnostics
Investigators
| Study Director: | Russell F. Hudnall | Integrated Diagnostics, Inc. |
More Information
| Responsible Party: | Integrated Diagnostics |
| ClinicalTrials.gov Identifier: | NCT01752114 History of Changes |
| Other Study ID Numbers: | PANOPTIC (1001-12) |
| Study First Received: | November 30, 2012 |
| Last Updated: | August 29, 2016 |
| Health Authority: | United States: Institutional Review Board |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by Integrated Diagnostics:
|
Precancerous conditions Carcinoma |
Additional relevant MeSH terms:
|
Disease Precancerous Conditions Multiple Pulmonary Nodules Pathologic Processes Neoplasms Lung Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on September 27, 2016