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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512757
• Other study ID #: Ajinomoto 2015-01
• Status: Completed
• Phase: N/A
• First received: July 27, 2015
• Last updated: February 26, 2018
• Start date: August 13, 2015
• Est. completion date: July 17, 2017

Study information

• Verified date: February 2018
• Source: Innovis LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 17, 2017
• Est. primary completion date: July 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Locations

Country	Name	City	State
United States	Pulmonary and Critical Care Associates of Baltimore	Baltimore	Maryland
United States	Florida Lung Asthma and Sleep Specialists P.A.	Celebration	Florida
United States	Vanderbilt-Ingram Cancer Center (VICC)	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Innovis LLC	Ajinomoto Co., Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The capability of AminoIndex™ to distinguish malignant lung cancer from benign lung nodules.		6 months
Secondary	Gathering residual patient samples that will be used for discovery research.		6 months