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Metabolic and Microbial Profiling of Lung Cancer

NCT03998189 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-11-05

Study results available
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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.

Conditions

  • Nonsmall Cell Lung Cancer
  • Nonsmall Cell Lung Cancer Stage

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Andrew Bishop, PhD · Wake Forest University Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-11
Primary Completion
2021-06-21
Completion
2021-06-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03998189 on ClinicalTrials.gov