Condition or disease | Intervention/treatment | Phase |
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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 |
Primary Objective
Secondary Objective
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 |
Arm | Intervention/treatment |
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Experimental: Female Participants
45 female patients will be screened to participate.
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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.
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Experimental: Male Participants
45 male patients will be screened to participate
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Andrew Bishop, PhD | Wake Forest University Health Sciences |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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
Secondary Objective
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Wake Forest University Health Sciences | ||||
Study Sponsor ICMJE | Wake Forest University Health Sciences | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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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 |