Trial Outcomes & Findings for Metabolic and Microbial Profiling of Lung Cancer (NCT NCT03998189)

Last Updated: 2021-11-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

One month

Results posted on

2021-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

Metabolic and Microbial Profiling of Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	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.	Male Participants n=1 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.	Total n=1 Participants Total of all reporting groups
Age, Customized Enrolled participant	—	82 years n=7 Participants	82 years n=5 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One month post surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

Adverse Events

Female Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Male Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Coordinator

Wake Forest Baptist Comprehensive Cancer Center

Phone: 336-713-4550

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place