Metabolic and Microbial Profiling of Lung Cancer

Pilot Study: Metabolic and Microbial Profiling of Lung Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Nonsmall Cell Lung Cancer; Nonsmall Cell Lung Cancer Stage
• Intervention / Treatment: Other: Breath Collection; Other: Saliva Collection; Other: Blood Collection; Other: Urine Collection; Other: Tumor Collection; Other: Medical History Data Collection

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Female Participants; 45 female patients will be screened to participate.	Other: Breath Collection; 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; Other: Saliva Collection; Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes; Other: Blood Collection; Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube; Other: Urine Collection; Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers; Other: Tumor Collection; During surgical tumor removal, a tumor tissue sample will be collected; Other: Medical History Data Collection; 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.
Experimental: Male Participants; 45 male patients will be screened to participate	Other: Breath Collection; 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; Other: Saliva Collection; Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes; Other: Blood Collection; Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube; Other: Urine Collection; Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers; Other: Tumor Collection; During surgical tumor removal, a tumor tissue sample will be collected; Other: Medical History Data Collection; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Andrew Bishop, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2019
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): June 21, 2021

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: IRB00059167; P30CA012197 (U.S. NIH Grant/Contract); WFBCCC 03219 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No