Metabolic and Microbial Profiling of Lung Cancer

Study Overview
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Brief Summary
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This pilot study will establish non-invasive sample collections, including breath, saliva, blood and urine pre-surgery and at the participant's one-month post-surgery follow-up visit. Participants with suspected non-small cell lung cancer (NSCLC) stage I-III will be recruited.

Detailed Description
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Primary Objective To evaluate the feasibility of adding non-invasive sample collections in the pre-surgical setting and at the post-surgery follow-up visit. To identify and assess metabolic and microbial signatures collected at pre- and post-surgery and determine which are indicative of lung cancer. Secondary Objective To identify signatures which are associated with lung cancer stage. To identify signatures which are impacted by patient's pulmonary function status.

Official Title
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Pilot Study: Metabolic and Microbial Profiling of Lung Cancer

Conditions
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Nonsmall Cell Lung Cancer, Nonsmall Cell Lung Cancer Stage

Intervention / Treatment
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* Other: Breath Collection
* Other: Saliva Collection
* Other: Blood Collection
* Other: Urine Collection
* Other: Tumor Collection
* Other: Medical History Data Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients age >18 years, of all racial and ethnic origins, with suspected nonsmall cell lung cancer stages I, II, and III, as evident through radiographic evidence and felt acceptable to undergo surgical resection. Patients who have the ability to understand and the willingness to sign a written consent form. Exclusion Criteria: Patients who are have taken antibiotics within two weeks. Patients who are on continuous supplemental oxygen. Patients currently undergoing active treatment for other malignancies. Subjects who are unable or unwilling to provide consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 45 female/ 45 male participants
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Female Participants<br>45 female patients will be screened to participate. | Other: Breath Collection<br>* Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing<br>Other: Saliva Collection<br>* Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes<br>Other: Blood Collection<br>* Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube<br>Other: Urine Collection<br>* Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers<br>Other: Tumor Collection<br>* During surgical tumor removal, a tumor tissue sample will be collected<br>Other: Medical History Data Collection<br>* Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease.<br>|
| Experimental: Male Participants<br>45 male patients will be screened to participate | Other: Breath Collection<br>* Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing<br>Other: Saliva Collection<br>* Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes<br>Other: Blood Collection<br>* Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube<br>Other: Urine Collection<br>* Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers<br>Other: Tumor Collection<br>* During surgical tumor removal, a tumor tissue sample will be collected<br>Other: Medical History Data Collection<br>* Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Needed for Feasibility | The primary objectives is to assess the feasibility of adding these non-invasive sample collections to pre- and post-surgery visits the following outcomes (counts) will be gathered - (number eligible for trial, number that consent to participate, number that provide pre-surgery samples, number that provide post-surgery samples) using a 95% exact Clopper-Pearson confidence interval for each feasibility estimate. | One month | 
| Pre-Surgery and Post-Surgery Metabolic Signatures | Metabolic assessments will be taken before and after surgery of lung cancer biomarkers to examine a series of paired t-tests to determine which markers significantly change between the two time points for participants. | One month post surgery | 
| Pre-Surgery and Post-Surgery Microbial Signatures | Metabolic assessments will be taken before and after surgery of lung cancer biomarkers to examine a series of paired t-tests to determine which markers significantly change between the two time points for participants. | One month post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of Lung Cancer Stage Specific Signatures | For lung cancer examine whether pre-surgery, post-surgery or change from pre- to post- surgery metabolic or microbial measures are different depending on lung cancer stage. Consideration of the metabolic or microbial measures as outcomes and use a general linear models framework to see if lung cancer stage (included as a class variable, but then examined as an ordinal variable using a contrast statement in general linear model) is associated with any marker. | One month post surgery | 
| Identification of Signatures Associated With Pulmonary Function | For pulmonary function, the same approach as for lung cancer stage, except that pulmonary function will be considered as a continuous variable in the model. Pulmonary function can be examined at both time-points (pre- and post- surgery) thus we can examine the relationships between pulmonary function measures and biomarker measures at each time points (and the change in measures over time). | One month post surgery |