Metabolic and Microbial Profiling of Lung Cancer

Nonsmall Cell Lung Cancer Clinical Trial

Official title:

Pilot Study: Metabolic and Microbial Profiling of Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03998189
• Other study ID #: IRB00059167
• Secondary ID: WFBCCC 03219P30C
• Status: Terminated
• Phase: N/A
• Start date: October 11, 2019
• Est. completion date: June 21, 2021

Study information

• Verified date: October 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Nonsmall Cell Lung Cancer
• Nonsmall Cell Lung Cancer Stage

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	One month
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.	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.	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.	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).	One month post surgery