Metabolic and Microbial Profiling of Lung Cancer

Not Applicable

Terminated

• Conditions: Nonsmall Cell Lung Cancer Stage; Nonsmall Cell Lung Cancer
• Interventions: Other: Breath Collection; Other: Saliva Collection; Other: Blood Collection; Other: Urine Collection; Other: Tumor Collection; Other: Medical History Data Collection

• Registration Number: NCT03998189
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-26
• Study Start: 2019-10-11
• Primary Completion: 2021-06-21
• Study Completion: 2021-06-21
• Results First Submitted: 2021-09-09
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-07
• Last Update Submitted: 2021-10-07
• Results First Posted: 2021-11-05
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Female Participants	Tumor Collection	45 female patients will be screened to participate.
Male Participants	Breath Collection	45 male patients will be screened to participate
Male Participants	Saliva Collection	45 male patients will be screened to participate
Male Participants	Medical History Data Collection	45 male patients will be screened to participate
Female Participants	Blood Collection	45 female patients will be screened to participate.
Female Participants	Medical History Data Collection	45 female patients will be screened to participate.
Male Participants	Urine Collection	45 male patients will be screened to participate
Male Participants	Tumor Collection	45 male patients will be screened to participate
Female Participants	Urine Collection	45 female patients will be screened to participate.
Male Participants	Blood Collection	45 male patients will be screened to participate
Female Participants	Breath Collection	45 female patients will be screened to participate.
Female Participants	Saliva Collection	45 female patients will be screened to participate.

Primary Outcome Measures

Name	Time	Method
Number of Participants Needed for Feasibility	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	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	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 Outcome Measures

Name	Time	Method
Identification of Signatures Associated With Pulmonary Function	One month post surgery	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).
Identification of Lung Cancer Stage Specific Signatures	One month post surgery	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.

Trial Locations

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States