Metabolic and Microbial Profiling of Lung Cancer

Wake Forest University (WFU)

Status: Terminated

Conditions: Nonsmall Cell Lung Cancer Stage; Nonsmall Cell Lung Cancer

Treatments: Other: Urine Collection; Other: Tumor Collection; Other: Saliva Collection; Other: Breath Collection; Other: Medical History Data Collection; Other: Blood Collection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03998189

P30CA012197 (U.S. NIH Grant/Contract)

WFBCCC 03219 (Other Identifier)

IRB00059167

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Female Participants

Experimental group

Description:

45 female patients will be screened to participate.

Treatment:

Other: Urine Collection

Other: Tumor Collection

Other: Saliva Collection

Other: Breath Collection

Other: Medical History Data Collection

Other: Blood Collection

Male Participants

Experimental group

Description:

45 male patients will be screened to participate

Treatment:

Other: Urine Collection

Other: Tumor Collection

Other: Saliva Collection

Other: Breath Collection

Other: Medical History Data Collection

Other: Blood Collection