Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

45 female patients will be screened to participate.

45 male patients will be screened to participate

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

Breath Collection

Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes

Saliva Collection

Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube

Blood Collection

Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers

Urine Collection

During surgical tumor removal, a tumor tissue sample will be collected

Tumor 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.

Medical History Data Collection

Andrew Bishop, PhD

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

* 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.

Metabolic and Microbial Profiling of Lung Cancer

Pilot Study: Metabolic and Microbial Profiling of Lung Cancer

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.

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.

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.

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).

National Cancer Institute (NCI)

Wake Forest University Health Sciences

There were no female participants enrolled on this study before it was terminated.

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.

Female 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.

Male Participants

Total

Enrolled participant

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study Coordinator

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Metabolic and Microbial Profiling of Lung Cancer	NCT03998189	Nonsmall Cell L... Nonsmall Cell L...	Breath Collecti... Saliva Collecti... Blood Collectio... Urine Collectio... Tumor Collectio... Medical History...	18 Years -	Wake Forest University Health Sciences
Metabolic and Microbial Profiling of Lung Cancer	NCT03998189	Nonsmall Cell L... Nonsmall Cell L...	Breath Collecti... Saliva Collecti... Blood Collectio... Urine Collectio... Tumor Collectio... Medical History...	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for medical history data collection