Nonsmall Cell Lung Cancer, Nonsmall Cell Lung Cancer Stage
Conditions
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.
Interventions
OTHERBreath 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
OTHERSaliva Collection
Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes
OTHERBlood Collection
Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube
OTHERUrine Collection
Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers
OTHERTumor Collection
During surgical tumor removal, a tumor tissue sample will be collected
OTHERMedical 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.
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
45 female/ 45 male participants
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Needed for Feasibility | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Identification of Lung Cancer Stage Specific Signatures | 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 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
Baseline characteristics
| Characteristic | Male Participants | Total |
|---|---|---|
| Age, Customized Enrolled participant | 82 years | 82 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
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.
Time frame: One month
Population: 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.
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.
Time frame: One month post surgery
Population: 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.
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.
Time frame: One month post surgery
Population: 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.
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.
Time frame: One month post surgery
Population: 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.
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).
Time frame: One month post surgery
Population: 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.