NCT03998189

Metabolic and Microbial Profiling of Lung Cancer

Pilot Study: Metabolic and Microbial Profiling of Lung Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonsmall Cell Lung Cancer
• Nonsmall Cell Lung Cancer Stage

Interventions

Type	Name	Description
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
OTHER	Saliva Collection	Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes
OTHER	Blood Collection	Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube
OTHER	Urine Collection	Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers
OTHER	Tumor Collection	During surgical tumor removal, a tumor tissue sample will be collected
OTHER	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.

Timeline

• Start date: 2019-10-11
• Primary completion: 2021-06-21
• Completion: 2021-06-21
• First posted: 2019-06-26
• Last updated: 2021-11-05
• Results posted: 2021-11-05

Locations

1 site across 1 country: United States