Nonsmall Cell Lung CancerNCT03998189
Metabolic and Microbial Profiling of Lung Cancer
A study testing Breath Collection, Saliva Collection and Blood Collection in people with Nonsmall Cell Lung Cancer and Nonsmall Cell Lung Cancer Stage, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer, Nonsmall Cell Lung Cancer Stage
- What is being tested?
- Breath Collection, Saliva Collection and Blood Collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2019to 21 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Pilot Study: Metabolic and Microbial Profiling of Lung Cancer
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.
Read the 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.
- Being tested
- Breath Collection, Saliva Collection, Blood Collection, Urine Collection, Tumor Collection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath CollectionOther
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 CollectionOther
Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes
Blood CollectionOther
Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube
Urine CollectionOther
Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers
Tumor CollectionOther
During surgical tumor removal, a tumor tissue sample will be collected
Medical History Data CollectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Female Participants | Experimental | 45 female patients will be screened to participate. Receives: 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 Receives: Other: Breath Collection; Other: Saliva Collection; Other: Blood Collection; Other: Urine Collection; Other: Tumor Collection; Other: Medical History Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: One month post surgery
Secondary outcomes (2)
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.
Measured: One month post surgery
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).
Measured: One month post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start11 Oct 2019
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Why it stopped: Study deemed no longer feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonsmall Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 45 female/ 45 male participants
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrew Bishop, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998189
- Sponsor's protocol ID
- IRB00059167
- Other IDs
- WFBCCC 03219, P30CA012197
- Status last verified
- Oct 2021
- First submitted
- 20 Jun 2019
- Last updated
- 5 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Metabolic and Microbial Profiling of Lung Cancer
- ClinicalTrials.gov ID
- NCT03998189
- Acronym / sponsor ID
- IRB00059167
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study deemed no longer feasible
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Posted 5 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 45 female/ 45 male participants
| Arm | Type | Receives |
|---|---|---|
| Female Participants | Experimental | Other: Breath Collection, Other: Saliva Collection, Other: Blood Collection, Other: Urine Collection, Other: Tumor Collection, Other: Medical History Data Collection45 female patients will be screened to participate. |
| Male Participants | Experimental | Other: Breath Collection, Other: Saliva Collection, Other: Blood Collection, Other: Urine Collection, Other: Tumor Collection, Other: Medical History Data Collection45 male patients will be screened to participate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath CollectionPre-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 | Female Participants, Male Participants |
| Saliva CollectionPre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes | Other | Female Participants, Male Participants |
| Blood CollectionPre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube | Other | Female Participants, Male Participants |
| Urine CollectionPre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers | Other | Female Participants, Male Participants |
| Tumor CollectionDuring surgical tumor removal, a tumor tissue sample will be collected | Other | Female Participants, Male Participants |
| Medical History Data CollectionMedical 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. | Other | Female Participants, Male Participants |
Primary outcome
Number of Participants Needed for Feasibility
Time frame: One month
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.
Pre-Surgery and Post-Surgery Metabolic Signatures
Time frame: One month post surgery
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.
Pre-Surgery and Post-Surgery Microbial Signatures
Time frame: One month post surgery
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.
2 secondary outcomes
Identification of Lung Cancer Stage Specific Signatures
Time frame: One month post surgery
Identification of Signatures Associated With Pulmonary Function
Time frame: One month post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Bishop, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath Collection, Saliva Collection and Blood Collection in people with Nonsmall Cell Lung Cancer and Nonsmall Cell Lung Cancer Stage, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Needed for Feasibility (time frame: One month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.