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

NCT02512757 | Completed

• 1 other identifier: Ajinomoto 2015-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Keywords

Neoplasms, Lung; Pulmonary Neoplasms; Pulmonary Cancer

Outcome Measures

Primary Outcomes (1)

• The diagnostic performance of AminoIndex™ to discriminate lung cancer patients from high-risk subjects.

  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.

  6 months

Secondary Outcomes (2)

• The capability of AminoIndex™ to distinguish malignant lung cancer from benign lung nodules.

  6 months

• Gathering residual patient samples that will be used for discovery research.

  6 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovis LLC: lead
• Ajinomoto Co., Inc.: collaborator

Study Sites (3)

Florida Lung Asthma and Sleep Specialists P.A.

Celebration, Florida, 34747, United States

Location

Pulmonary and Critical Care Associates of Baltimore

Baltimore, Maryland, 21237, United States

Location

Vanderbilt-Ingram Cancer Center (VICC)

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Subjects will consent to archiving and future analysis of their blood samples for up to twenty (20) years.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gregg S. Britt

  Innovis LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 31, 2015
• Study Start: August 13, 2015
• Primary Completion: July 17, 2017
• Study Completion: July 17, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)