Lung Cancer Trials Ask AI to find trials
CompletedNot applicableNCT02512757
Official study title

A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology

Study summary

This is a prospective, multi-center study to evaluate the diagnostic performance characteristics of the AminoIndex™ technology among patients at high risk for developing lung cancer as compared with standard lung cancer screening and diagnostic procedures including low-dose CT, high-dose CT, biopsy and histopathology.

Ask AI to explain this study
Start here

Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 28, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Innovis LLC

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Innovis LLC
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • All Groups:
  • Able to read, understand and sign informed consent to participate in study.
  • Willing and able to provide written informed consent.
  • Willing and able to meet all study requirements and undergo venipuncture to provide a fasting blood sample. Group 1:
  • Men or women age 18 years or older;
  • Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung, nodule or mass.
  • Diagnosis of lung cancer based upon histopathology performed on lung nodule, lesion or mass tissue obtained from biopsy or surgical excision performed after study-related fasting blood sample obtained. Group 2:
  • Men or women age 18 years or older;
  • Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung nodule, lesion or mass;
  • Definitive diagnosis of benign (non-cancerous) lung nodule based upon one of the following:
  • Histopathology performed on lung nodule tissue obtained from biopsy or surgical excision performed after study-related fasting blood sample obtained;
  • No nodule growth for \> 2 years by repeat CT imaging, the most recent being performed within the 60 days prior to signing informed consent. Group 3:
  • Men or women age 55-79 years inclusive;
  • Current smoker or quit \< 15 years ago with a \> 30 pack-year smoking history (equivalent of 1 pack per day for 30 or more years)\*.
  • Have undergone low-dose computed tomography (LDCT) or standard computed tomography (CT) or X-ray testing to screen for lung cancer with no nodules suspicious for lung cancer within 1 year prior to signing informed consent. ' \
  • ' One pack year is calculated as follows: 20 cigarettes = 1 pack. One "pack year" is the equivalent of smoking:
  • 20 cigarettes (one pack) per day for one year; or
  • 40 cigarettes (two packs) per day for 6 months; or
  • 60 cigarettes (three packs) per day for 3 months
Reasons someone may not be able to joinExclusion criteria
  • Inability to fast for 8 hours prior to the blood sample collection.
  • Known to be positive for HIV and/or, HBV and/or HCV.
  • Pregnancy.
  • Breastfeeding.
  • Currently undergoing dialysis.
  • Congenital metabolic disease.
  • Currently receiving investigational treatments of any type.
  • History of receiving any drug therapy or surgery for the treatment of lung cancer.
  • Diagnosis of cancer within past 5 years and/or currently undergoing treatment for any cancer.
  • Any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would be mean participation in the study would be contraindicated.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Florida Lung Asthma and Sleep Specialists P.A.Celebration, Florida
  • Pulmonary and Critical Care Associates of BaltimoreBaltimore, Maryland
  • Vanderbilt-Ingram Cancer Center (VICC)Nashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 28, 2018. Always confirm current availability with the study team.

View original record ↗