Lung CancerNCT02294578
Salivary Biomarkers for Non-small Cell Lung Cancer Detection
An observational study of Lung Cancer, run by PeriRx at 2 sites in United States.
Trial summary
The investigators plan to recruit patients for a prospective study in patients in need of evaluation for lung lesions suspicious for cancer. Saliva samples will be collected before diagnostic evaluation including biopsy with subsequent blinded examination of the salivary markers without knowledge of the disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 166 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting for evaluation of lung lesions suspicious for the presence of lung cancer.
Who may be able to join
- Any patient presenting to the participating institutions of affiliated clinics for evaluation or biopsy of a lung lesion suspicious for cancer.
- Patients ≥ 18 years of age
- Patients willing and able to give informed consent
Who cannot join
- Diagnosis of cancer within the last two years, excluding non-melanoma skin cancer (if > 2 years since diagnosis, must be free of known disease \& not on current treatment for cancer).
- Prior immunosuppressive therapy or autoimmune disorder
- Known HIV infection
- Known Hepatitis infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
St. John Macomb-Oakland Hospital
Warren, Michigan, 48093
Shirley Ayuk Takem, DO, 215-833-9637, Shirley.Ayuk-Takem@stjohn.org]
Larry Tankenow, MD, 586 751-8844, lbt.pma@comcast.net
- Recruiting
Main Line Health Ststem
Wynnewood, Pennsylvania, 19096
Tom Meyer, MD, 610-642-3796
Melinda Milliken, 610 642 3796
About this study
Official title: Prospective Blinded Evaluation of Salivary Transcriptome Biomarkers for Non-small Cell Lung Cancer Detection
The investigators plan to recruit patients for a prospective study in patients in need of evaluation for lung lesions suspicious for cancer. Saliva samples will be collected before diagnostic evaluation including biopsy with subsequent blinded examination of the salivary markers without knowledge of the disease status. This prospective recruitment with retrospective blinded evaluation or PRoBE design satisfies the highest standards recommended by the National Cancer Institute for biomarker development. This process limits the selection bias that can confound retrospective studies. As the primary endpoint, a pre-specified multi-marker panel will be evaluated based on the combination of sensitivity and specificity. In addition, seven pre-specified individual candidate mRNA cancer markers and six internal reference or "housekeeping" genes will be evaluated. The performance of new multi-marker panels will also be assessed and compared with the prior pre-specified model based on sensitivity and specificity combinations as well as the area under the receiver operating characteristic curve.
Read the detailed description
Consecutive eligible patients presenting to the study institutions and associated clinics will be enrolled. Inclusion and exclusion criteria are detailed separately in the section on eligibility. The target enrollment population listed in the study design section provides a greater than 85% power to achieve the pre-specified goal for the sensitivity and specificity of the pre-specified model. Saliva will be collected in vials pre filled with mRNA stabilizer. Seven mRNA biomarkers (BRAF, CCNI, EGRF, FGF19, FRS2, GREB1, and LZTS1) will be measured in a central laboratory by quantitative PCR with the laboratory personnel blinded to the patient diagnosis. The primary outcome is the validation of a pre-specified multi-marker model. This pre-specified model incorporates 3 of the cancer genes and the housekeeping gene. The model will be validated based on the sum of sensitivity and specificity exceeding 1.3 with the lower limit of the 95% confidence interval exceeding 1.0. A secondary endpoint is the development of new multi-maker models with potential improved performance. These new models will be developed by logistic regression and compared with the pre-specified model based on the area under the receiver operating characteristic curve and the maximum sum of sensitivity and specificity. Individual candidate biomarkers will also be validated based on a statistically significant up-regulation in cancer patients compared with controls. Potential new housekeeping genes will be evaluated based on their equivalence in cancer and control as well as their performance in multi-marker models in comparison with the pre-specified housekeeping gene which is GADPH..
- Conditions
- Lung Cancer
- Keywords
- Biomarkers, saliva, mRNA
- 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 |
|---|---|---|
| Lung Cancer | Patients with biopsy proven lung cancer | |
| Controls | Patients with lung lesions suspicious for the presence of cancer and with cancer excluded after further diagnostic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of a pre-specified multi-marker panel (incorporating 3 of the 7 pre-specified cancer genes and the housekeeping gene)
Multi-marker test score conmined sensitivity abd specificity
Measured: Patients will be followed until their work up determines if they have benign pathology or lung cancer and the stage is determined. The complete analysis of biomarkers will occur at approximately 15 months after the start of enrollment.
Secondary outcomes (3)
Validation of the individual mRNA biomarkers (BRAF, CCN1, EGRF, FGF19, FRS2,GREB1 and LZTS1)
Delta Ct values based on PCR analysis comparing cancer and controls
Measured: Patients will be followed until their work up determines if they have benign pathology or lung cancer and the stage is determined. The complete analysis of biomarkers will occur at approximately 15 months after the start of enrollment.
Performance of new multi-marker models
Multi-marker test score combined sensitivity and specificity
Measured: Patients will be followed until their work up determines if they have benign pathology or lung cancer and the stage is determined. The complete analysis of biomarkers will occur at approximately 15 months after the start of enrollment.
Performance of new candidate housekeeping genes
Based on Normfinder stability
Measured: Patients will be followed until their work up determines if they have benign pathology or lung cancer and the stage is determined. The complete analysis of biomarkers will occur at approximately 15 months after the start of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
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
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PeriRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jack Martin, MD, PeriRx
- Investigators
- Jack L Martin, MD, Study chair, PeriRx, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294578
- Sponsor's protocol ID
- PeriRx LC
- Status last verified
- Apr 2018
- First submitted
- 5 Nov 2014
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Blinded Evaluation of Salivary Transcriptome Biomarkers for Non-small Cell Lung Cancer Detection
- ClinicalTrials.gov ID
- NCT02294578
- Acronym / sponsor ID
- PeriRx LC
- Conditions
- Lung Cancer
- Keywords
- Biomarkers, saliva, mRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- PeriRxIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 19 Nov 2014 (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.
The investigators plan to recruit patients for a prospective study in patients in need of evaluation for lung lesions suspicious for cancer. Saliva samples will be collected before diagnostic evaluation including biopsy with subsequent blinded examination of the salivary markers without knowledge of the disease status. This prospective recruitment with retrospective blinded evaluation or PRoBE design satisfies the highest standards recommended by the National Cancer Institute for biomarker development. This process limits the selection bias that can confound retrospective studies. As the primary endpoint, a pre-specified multi-marker panel will be evaluated based on the combination of sensitivity and specificity. In addition, seven pre-specified individual candidate mRNA cancer markers and six internal reference or "housekeeping" genes will be evaluated. The performance of new multi-marker panels will also be assessed and compared with the prior pre-specified model based on sensitivity and specificity combinations as well as the area under the receiver operating characteristic curve.
Detailed description
Consecutive eligible patients presenting to the study institutions and associated clinics will be enrolled. Inclusion and exclusion criteria are detailed separately in the section on eligibility. The target enrollment population listed in the study design section provides a greater than 85% power to achieve the pre-specified goal for the sensitivity and specificity of the pre-specified model. Saliva will be collected in vials pre filled with mRNA stabilizer. Seven mRNA biomarkers (BRAF, CCNI, EGRF, FGF19, FRS2, GREB1, and LZTS1) will be measured in a central laboratory by quantitative PCR with the laboratory personnel blinded to the patient diagnosis. The primary outcome is the validation of a pre-specified multi-marker model. This pre-specified model incorporates 3 of the cancer genes and the housekeeping gene. The model will be validated based on the sum of sensitivity and specificity exceeding 1.3 with the lower limit of the 95% confidence interval exceeding 1.0. A secondary endpoint is the development of new multi-maker models with potential improved performance. These new models will be developed by logistic regression and compared with the pre-specified model based on the area under the receiver operating characteristic curve and the maximum sum of sensitivity and specificity. Individual candidate biomarkers will also be validated based on a statistically significant up-regulation in cancer patients compared with controls. Potential new housekeeping genes will be evaluated based on their equivalence in cancer and control as well as their performance in multi-marker models in comparison with the pre-specified housekeeping gene which is GADPH..
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer | – | –Patients with biopsy proven lung cancer |
| Controls | – | –Patients with lung lesions suspicious for the presence of cancer and with cancer excluded after further diagnostic study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting for evaluation of lung lesions suspicious for the presence of lung cancer.
Key inclusion criteria (3 listed)
- Any patient presenting to the participating institutions of affiliated clinics for evaluation or biopsy of a lung lesion suspicious for cancer.
- Patients ≥ 18 years of age
- Patients willing and able to give informed consent
Key exclusion criteria (4 listed)
- Diagnosis of cancer within the last two years, excluding non-melanoma skin cancer (if > 2 years since diagnosis, must be free of known disease \& not on current treatment for cancer).
- Prior immunosuppressive therapy or autoimmune disorder
- Known HIV infection
- Known Hepatitis infection
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
Performance of a pre-specified multi-marker panel (incorporating 3 of the 7 pre-specified cancer genes and the housekeeping gene)
Time frame: Patients will be followed until their work up determines if they have benign pathology or lung cancer and the stage is determined. The complete analysis of biomarkers will occur at approximately 15 months after the start of enrollment.
Multi-marker test score conmined sensitivity abd specificity
3 secondary outcomes
Validation of the individual mRNA biomarkers (BRAF, CCN1, EGRF, FGF19, FRS2,GREB1 and LZTS1)
Time frame: Patients will be followed until their work up determines if they have benign pathology or lung cancer and the stage is determined. The complete analysis of biomarkers will occur at approximately 15 months after the start of enrollment.
Performance of new multi-marker models
Time frame: Patients will be followed until their work up determines if they have benign pathology or lung cancer and the stage is determined. The complete analysis of biomarkers will occur at approximately 15 months after the start of enrollment.
Performance of new candidate housekeeping genes
Time frame: Patients will be followed until their work up determines if they have benign pathology or lung cancer and the stage is determined. The complete analysis of biomarkers will occur at approximately 15 months after the start of enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jack L Martin, MD study chair
PeriRx, LLC
2 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 PeriRx at 2 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jack L Martin, MD (610 544 3500, Martinj@mlhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of a pre-specified multi-marker panel (incorporating 3 of the 7 pre-specified cancer genes and the housekeeping gene) (time frame: Patients will be followed until their work up determines if they have benign pathology or lung cancer and the stage is determined. The complete analysis of biomarkers will occur at approximately 15 months after the start of enrollment.). 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 12 Apr 2018.