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出境医 / 临床实验 / Metabolic and Microbial Profiling of Lung Cancer

Metabolic and Microbial Profiling of Lung Cancer

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.

Condition or disease Intervention/treatment Phase
Nonsmall Cell Lung Cancer Nonsmall Cell Lung Cancer Stage Other: Breath Collection Other: Saliva Collection Other: Blood Collection Other: Urine Collection Other: Tumor Collection Other: Medical History Data Collection Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 45 female/ 45 male participants
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study: Metabolic and Microbial Profiling of Lung Cancer
Actual Study Start Date : October 11, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021
Arms and Interventions
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.

Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 Outcome Measures :
  1. Identification of Lung Cancer Stage Specific Signatures [ Time Frame: 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.

  2. Identification of Signatures Associated with Pulmonary Function [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
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United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Study Coordinator    336-716-5440    aohlmans@wakehealthe.edu   
Principal Investigator: Andrew Bishop, PhD         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Andrew Bishop, PhD Wake Forest University Health Sciences
Tracking Information
First Submitted Date  ICMJE June 20, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE October 11, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • 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.
  • Presence of 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.
  • Presence of 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Identification of Lung Cancer Stage Specific Signatures [ Time Frame: 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.
  • Identification of Signatures Associated with Pulmonary Function [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolic and Microbial Profiling of Lung Cancer
Official Title  ICMJE Pilot Study: Metabolic and Microbial Profiling of Lung Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
45 female/ 45 male participants
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Nonsmall Cell Lung Cancer
  • Nonsmall Cell Lung Cancer Stage
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Female Participants
    45 female patients will be screened to participate.
    Interventions:
    • Other: Breath Collection
    • Other: Saliva Collection
    • Other: Blood Collection
    • Other: Urine Collection
    • Other: Tumor Collection
    • Other: Medical History Data Collection
  • Experimental: Male Participants
    45 male patients will be screened to participate
    Interventions:
    • Other: Breath Collection
    • Other: Saliva Collection
    • Other: Blood Collection
    • Other: Urine Collection
    • Other: Tumor Collection
    • Other: Medical History Data Collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 21, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998189
Other Study ID Numbers  ICMJE IRB00059167
WFBCCC 03219 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
P30CA012197 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Andrew Bishop, PhD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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