Lung CancerNCT02512757
A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
An observational study of Lung Cancer, run by Innovis LLC at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Aug 2015to 17 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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;
Show all 22Show fewer
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, 21237
Florida Lung Asthma and Sleep Specialists P.A.
Celebration, Florida, 34747
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, 37232
About this study
Official title: The AminoIndex™ Study - A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
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.
Read the 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:
- 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;
- 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
- patients at high-risk for lung cancer (per NLST guidelines) with no evidence or history of lung cancer (negative LDCT/CT/X-ray).
- Conditions
- Lung Cancer
- Keywords
- Neoplasms, Lung, Pulmonary Neoplasms, Pulmonary Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
The capability of AminoIndex™ to distinguish malignant lung cancer from benign lung nodules.
Measured: 6 months
Gathering residual patient samples that will be used for discovery research.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study start13 Aug 2015
- Primary completion17 Jul 2017
- Study completion17 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ajinomoto Co., Inc.
- Responsible party
- Sponsor
- Investigators
- Gregg S. Britt, Study director, Innovis LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512757
- Sponsor's protocol ID
- Ajinomoto 2015-01
- Status last verified
- Feb 2018
- First submitted
- 27 Jul 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AminoIndex™ Study - A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
- ClinicalTrials.gov ID
- NCT02512757
- Acronym / sponsor ID
- Ajinomoto 2015-01
- Conditions
- Lung Cancer
- Keywords
- Neoplasms, Lung, Pulmonary Neoplasms, Pulmonary Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Innovis LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ajinomoto Co., Inc.
- Study start
- 13 Aug 2015 (actual)
- Primary completion
- 17 Jul 2017 (actual)
- Study completion
- 17 Jul 2017 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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
- patients at high-risk for lung cancer (per NLST guidelines) with no evidence or history of lung cancer (negative LDCT/CT/X-ray).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (22 listed)
- 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.
- Men or women age 18 years or older;
- Lung nodule size ≥ 6 mm but ≤ 35 mm/ lung, nodule or mass.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
The capability of AminoIndex™ to distinguish malignant lung cancer from benign lung nodules.
Time frame: 6 months
Gathering residual patient samples that will be used for discovery research.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregg S. Britt study director
Innovis LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Innovis LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic performance of AminoIndex™ to discriminate lung cancer patients from high-risk subjects. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.