Carcinoma Clinical Trial
Official title:
Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12
Verified date | August 2016 |
Source | Integrated Diagnostics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 684 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Institute Universitarie de Cardiologie et de Pneumologie | Quebec | |
Canada | University Health Network - Toronto General Hospital | Toronto | Ontario |
United States | Georgia Lung Associates | Austell | Georgia |
United States | Johns Hopkins Medical Center | Baltimore | Maryland |
United States | Pulmonary & Crit Care Associates of Baltimore | Baltimore | Maryland |
United States | Charleston Research Institute | Charleston | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Carolinas HealthCare System | Charlotte | North Carolina |
United States | St. Luke's Medical Center | Chesterfield | Missouri |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Suburban Lung Associates | Elk Grove Village | Illinois |
United States | Inova Healthcare | Fairfax | Virginia |
United States | LeBaurer Healthcare | Greensboro | North Carolina |
United States | University of Southern California | Los Angeles | California |
United States | Kentuckiana Pulmonary Associates | Louisville | Kentucky |
United States | Virginia Piper Cancer Institute - Allina Health | Minneapolis | Minnesota |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | New York University Clinical Cancer Center | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | St. Joseph's Hospital & Medical Center | Phoenix | Arizona |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | Oregon Clinic | Portland | Oregon |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Beaumont Health System | Royal Oak | Michigan |
United States | California Pacific Medical Center | San Francisco | California |
United States | Sarasota Memorial Hospital | Sarasota | Florida |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Baystate Health | Springfield | Massachusetts |
United States | Scott & White Clinic | Temple | Texas |
United States | Pulmonary Associates of Southern Arizona | Tucson | Arizona |
United States | Salem Chest Specialists | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Integrated Diagnostics |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years post enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05283226 -
Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy
|
Phase 2 | |
Active, not recruiting |
NCT04362072 -
Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer
|
Phase 4 | |
Completed |
NCT04033991 -
Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
|
||
Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
Not yet recruiting |
NCT02907606 -
Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study
|
N/A | |
Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
Completed |
NCT01942200 -
A Non Interventional Study With Oxaliplatin Onkovis (Oxaliplatin) Utilized for the Treatment of Cancer
|
||
Completed |
NCT01061645 -
Study of MOC31-PE in Antigen Positive Carcinomas
|
Phase 1 | |
Completed |
NCT00532155 -
A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
|
Phase 3 | |
Terminated |
NCT00557596 -
A Phase 1-2, XIAP Antisense AEG35156 With Gemcitabine in Patients With Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT00216372 -
Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis
|
Phase 3 | |
Recruiting |
NCT06022757 -
Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
|
Phase 1/Phase 2 | |
Recruiting |
NCT05520281 -
Short-term Psychodynamic Psychotherapy in Serious Physical Illness
|
N/A | |
Recruiting |
NCT05752357 -
The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
|
||
Not yet recruiting |
NCT05023928 -
Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer
|
Phase 1 | |
Completed |
NCT00446446 -
PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)
|
Phase 2 | |
Recruiting |
NCT04566952 -
Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
|
Phase 2 | |
Not yet recruiting |
NCT06112041 -
The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)
|
Phase 2 | |
Completed |
NCT03562897 -
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer
|
Phase 2 | |
Recruiting |
NCT06013111 -
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors
|
Phase 1 |