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Metabolic and Microbial Profiling of Lung Cancer

Primary Purpose

Nonsmall Cell Lung Cancer, Nonsmall Cell Lung Cancer Stage

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breath Collection
Saliva Collection
Blood Collection
Urine Collection
Tumor Collection
Medical History Data Collection
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nonsmall Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wake Forest Baptist Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Female Participants

Male Participants

Arm Description

45 female patients will be screened to participate.

45 male patients will be screened to participate

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
June 20, 2019
Last Updated
October 7, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03998189
Brief Title
Metabolic and Microbial Profiling of Lung Cancer
Official Title
Pilot Study: Metabolic and Microbial Profiling of Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Study deemed no longer feasible
Study Start Date
October 11, 2019 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsmall Cell Lung Cancer, Nonsmall Cell Lung Cancer Stage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
45 female/ 45 male participants
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Female Participants
Arm Type
Experimental
Arm Description
45 female patients will be screened to participate.
Arm Title
Male Participants
Arm Type
Experimental
Arm Description
45 male patients will be screened to participate
Intervention Type
Other
Intervention Name(s)
Breath Collection
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Saliva Collection
Intervention Description
Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes
Intervention Type
Other
Intervention Name(s)
Blood Collection
Intervention Description
Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube
Intervention Type
Other
Intervention Name(s)
Urine Collection
Intervention Description
Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers
Intervention Type
Other
Intervention Name(s)
Tumor Collection
Intervention Description
During surgical tumor removal, a tumor tissue sample will be collected
Intervention Type
Other
Intervention Name(s)
Medical History Data Collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Needed for Feasibility
Description
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.
Time Frame
One month
Title
Pre-Surgery and Post-Surgery Metabolic Signatures
Description
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.
Time Frame
One month post surgery
Title
Pre-Surgery and Post-Surgery Microbial Signatures
Description
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.
Time Frame
One month post surgery
Secondary Outcome Measure Information:
Title
Identification of Lung Cancer Stage Specific Signatures
Description
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.
Time Frame
One month post surgery
Title
Identification of Signatures Associated With Pulmonary Function
Description
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).
Time Frame
One month post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Bishop, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Metabolic and Microbial Profiling of Lung Cancer

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