Salivary Biomarkers for Non-small Cell Lung Cancer Detection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening

NCT00607425

Non-Small Cell Lung Cancer

TERMINATED

Liquid Biopsy for Early Non-small Lung Cancer Detection

NCT05462795

Non Small-cell Lung Cancer

COMPLETED

Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers

NCT00897364

Lung Cancer Precancerous Condition

COMPLETED

Identifying Biomarkers for Lung Cancer Using Tissue Samples From Patients With Lung Cancer and From Healthy Participants

NCT00899028

Lung Cancer

COMPLETED

Monitoring the Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy.

NCT03397355

Lung Cancer

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lung Cancer

Patients with biopsy proven lung cancer

No interventions assigned to this group

Controls

Patients with lung lesions suspicious for the presence of cancer and with cancer excluded after further diagnostic study

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No