Pilot Study: Metabolic and Microbial Profiling of Lung Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Number of Participants Needed for Feasibility
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Female Participants
45 female patients will be screened to participate.
Intervention: Breath Collection (Other)
Female Participants
45 female patients will be screened to participate.
Intervention: Saliva Collection (Other)
Female Participants
45 female patients will be screened to participate.
Intervention: Blood Collection (Other)
Female Participants
45 female patients will be screened to participate.
Intervention: Urine Collection (Other)
Female Participants
45 female patients will be screened to participate.
Intervention: Tumor Collection (Other)
Female Participants
45 female patients will be screened to participate.
Intervention: Medical History Data Collection (Other)
Male Participants
45 male patients will be screened to participate
Intervention: Breath Collection (Other)
Male Participants
45 male patients will be screened to participate
Intervention: Saliva Collection (Other)
Male Participants
45 male patients will be screened to participate
Intervention: Blood Collection (Other)
Male Participants
45 male patients will be screened to participate
Intervention: Urine Collection (Other)
Male Participants
45 male patients will be screened to participate
Intervention: Tumor Collection (Other)
Male Participants
45 male patients will be screened to participate
Intervention: Medical History Data Collection (Other)
Outcomes
Primary Outcomes
Number of Participants Needed for Feasibility
Time Frame: One month
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.
Pre-Surgery and Post-Surgery Metabolic Signatures
Time Frame: One month post surgery
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.
Pre-Surgery and Post-Surgery Microbial Signatures
Time Frame: One month post surgery
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.
Secondary Outcomes
- Identification of Signatures Associated With Pulmonary Function(One month post surgery)
- Identification of Lung Cancer Stage Specific Signatures(One month post surgery)