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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 03219 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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Study deemed no longer feasible
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
Primary Objective
Secondary Objective
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female Participants | Experimental | 45 female patients will be screened to participate. |
|
| Male Participants | Experimental | 45 male patients will be screened to participate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath Collection | Other | 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 |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Bishop, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Female Participants | 45 female patients will be screened to participate. 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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. |
| FG001 | Male Participants | 45 male patients will be screened to participate 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
There were no female participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Female Participants | 45 female patients will be screened to participate. 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Biosamples that were collected were not analyzed as the analysis would be done once a proper batch of samples were collected. Given that never happened, investigators have no study results to report. | Posted | One month |
|
4 weeks
There were no female participants enrolled on this study before it was terminated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Female Participants | 45 female patients will be screened to participate. 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Wake Forest Baptist Comprehensive Cancer Center | 336-713-4550 | aohlmans@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2019 | Sep 9, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 11, 2020 | Sep 9, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D059349 | Urine Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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45 female/ 45 male participants
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| Saliva Collection | Other | Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes |
|
| Blood Collection | Other | Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube |
|
| Urine Collection | Other | Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers |
|
| Tumor Collection | Other | During surgical tumor removal, a tumor tissue sample will be collected |
|
| Medical History Data Collection | Other | 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. |
|
| 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 |
| BG001 | Male Participants | 45 male patients will be screened to participate 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Male Participants | 45 male patients will be screened to participate 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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. |
|
| Primary | 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. | Biosamples that were collected were not analyzed as the analysis would be done once a proper batch of samples were collected. Given that never happened, investigators have no study results to report. | Posted | One month post surgery |
|
|
| Primary | 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. | Biosamples that were collected were not analyzed as the analysis would be done once a proper batch of samples were collected. Given that never happened, investigators have no study results to report. | Posted | One month post surgery |
|
|
| Secondary | 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. | Biosamples that were collected were not analyzed as the analysis would be done once a proper batch of samples were collected. Given that never happened, investigators have no study results to report. | Posted | One month post surgery |
|
|
| Secondary | 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). | Biosamples that were collected were not analyzed as the analysis would be done once a proper batch of samples were collected. Given that never happened, investigators have no study results to report. | Posted | One month post surgery |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Male Participants | 45 male patients will be screened to participate 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |