Clinical trial NCT02512757: A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
Official title: The AminoIndex™ Study - A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Neoplasms, Lung
Pulmonary Neoplasms
Pulmonary Cancer
Lead sponsor: Innovis LLC
Sponsor class: INDUSTRY
Collaborators: name: Ajinomoto Co., Inc.
First posted: 2015-07-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility 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.

Primary outcomes:
measure: The diagnostic performance of AminoIndex™ to discriminate lung cancer patients from high-risk subjects.
timeFrame: 6 months
Secondary outcomes:
measure: The capability of AminoIndex™ to distinguish malignant lung cancer from benign lung nodules.
timeFrame: 6 months
measure: Gathering residual patient samples that will be used for discovery research.
timeFrame: 6 months
Other outcomes:
Locations:
city: Celebration
country: United States
facility: Florida Lung Asthma and Sleep Specialists P.A.
state: Florida
city: Baltimore
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center (VICC)
state: Tennessee
Study officials:
affiliation: Innovis LLC
name: Gregg S. Britt
role: STUDY_DIRECTOR
References: