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Trial record 1 of 1 for:    A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
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A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology

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ClinicalTrials.gov Identifier: NCT02512757
Recruitment Status : Completed
First Posted : July 31, 2015
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Ajinomoto Co., Inc.
Information provided by (Responsible Party):
Innovis LLC

Brief 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.

Condition or disease
Lung Cancer

Detailed Description:

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.

The study will enroll patients into one of three arms:

  1. patients with lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and diagnosed with primary lung cancer who have not yet initiated treatment of any kind for their lung cancer;
  2. patients with lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and determined to not be cancerous OR that have demonstrated no nodule growth for > 2 years by repeat CT imaging; and
  3. patients at high-risk for lung cancer (per NLST guidelines) with no evidence or history of lung cancer (negative LDCT/CT/X-ray).

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The AminoIndex™ Study - A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
Actual Study Start Date : August 13, 2015
Actual Primary Completion Date : July 17, 2017
Actual Study Completion Date : July 17, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Group 1
Patients with lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and diagnosed with primary lung cancer who have not yet initiated treatment of any kind for their lung cancer will contribute a fasting blood sample.
Group 2
Patients whose most recent screening imaging is within 60 days who have lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and determined to not be cancerous OR that have demonstrated no nodule growth for >2 years by repeat CT imaging will contribute a fasting blood sample.
Group 3
Patients who 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 will contribute a fasting blood sample.



Primary Outcome Measures :
  1. The diagnostic performance of AminoIndex™ to discriminate lung cancer patients from high-risk subjects. [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. The capability of AminoIndex™ to distinguish malignant lung cancer from benign lung nodules. [ Time Frame: 6 months ]
  2. Gathering residual patient samples that will be used for discovery research. [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Subjects will consent to archiving and future analysis of their blood samples for up to twenty (20) years.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Study will enroll sufficient subjects to yield a minimum of 60 subjects in Study Group 1, 30 subjects in Study Group 2 and 60 subjects in Study Group 3 - a total of 150 evaluable study subjects who meet all inclusion and exclusion criteria. Eligible subjects will be men and women age ≥ 18 years for Group 1 and 2 and 55 - 79 years inclusive for Group 3. Group 3 study subjects must also meet NLST guidelines of being at high risk for lung cancer: greater than or equal to a 30 pack year smoking history (equivalent of 1 pack per day for 30 or more years) and a current smoker or quit less than 15 years ago.
Criteria

Inclusion 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

Exclusion 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02512757


Locations
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United States, Florida
Florida Lung Asthma and Sleep Specialists P.A.
Celebration, Florida, United States, 34747
United States, Maryland
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States, 21237
United States, Tennessee
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Innovis LLC
Ajinomoto Co., Inc.
Investigators
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Study Director: Gregg S. Britt Innovis LLC
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Responsible Party: Innovis LLC
ClinicalTrials.gov Identifier: NCT02512757    
Other Study ID Numbers: Ajinomoto 2015-01
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Innovis LLC:
Neoplasms, Lung
Pulmonary Neoplasms
Pulmonary Cancer