Metabolic and Microbial Profiling of Lung Cancer

NCT03998189 | Terminated Results

• 3 other identifiers: IRB00059167WFBCCC 03219P30CA012197
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Identification of Lung Cancer Stage Specific Signatures

  One month post surgery

• Identification of Signatures Associated With Pulmonary Function

  One month post surgery

Study Arms (2)

Female Participants

EXPERIMENTAL

45 female patients will be screened to participate.

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

Male Participants

EXPERIMENTAL

45 male patients will be screened to participate

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

Interventions

Breath Collection OTHER

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

Female Participants; Male Participants

Saliva Collection OTHER

Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes

Female Participants; Male Participants

Blood Collection OTHER

Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube

Female Participants; Male Participants

Urine Collection OTHER

Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers

Female Participants; Male Participants

Tumor Collection OTHER

During surgical tumor removal, a tumor tissue sample will be collected

Female Participants; Male Participants

Medical History Data Collection OTHER

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.

Female Participants; Male Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Study Coordinator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

aohlmans@wakehealth.edu

336-713-4550

Study Officials

• Andrew Bishop, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 45 female/ 45 male participants

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 26, 2019
• Study Start: October 11, 2019
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: November 5, 2021
• Results First Posted: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)