Metabolic and Microbial Profiling of Lung Cancer

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03998189
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.3
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nonsmall Cell Lung Cancer; Nonsmall Cell Lung Cancer Stage	Other: Breath Collection; Other: Saliva Collection; Other: Blood Collection; Other: Urine Collection; Other: Tumor Collection; Other: Medical History Data Collection	N/A

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

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 45 female/ 45 male participants45 female/ 45 male participants
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pilot Study: Metabolic and Microbial Profiling of Lung Cancer
• Actual Study Start Date: Oct 11, 2019
• Actual Primary Completion Date: Jun 21, 2021
• Actual Study Completion Date: Jun 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Female Participants 45 female patients will be screened to participate.	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.
Experimental: Male Participants 45 male patients will be screened to participate	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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Needed for Feasibility [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.

2. Pre-Surgery and Post-Surgery Metabolic Signatures [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.

3. Pre-Surgery and Post-Surgery Microbial Signatures [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.

Secondary Outcome Measures

1. Identification of Lung Cancer Stage Specific Signatures [One month post surgery]

   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.

2. Identification of Signatures Associated With Pulmonary Function [One month post surgery]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Andrew Bishop, PhD, Wake Forest University Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 3, 2019
• Informed Consent Form - Jun 11, 2020

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03998189
• Other Study ID Numbers: IRB00059167; WFBCCC 03219; P30CA012197
• First Posted: Jun 26, 2019
• Last Update Posted: Nov 5, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

Participant Flow

Arm/Group Title	Female Participants	Male Participants
Arm/Group Description	45 female patients will be screened to participate. 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.	45 male patients will be screened to participate 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.
Period Title: Overall Study
STARTED	0	1
COMPLETED	0	0
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Female Participants	Male Participants	Total
Arm/Group Description	45 female patients will be screened to participate. 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.	45 male patients will be screened to participate 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.	Total of all reporting groups
Overall Participants	0	1	1
Age, Customized (years) [Number]
Enrolled participant	82	82
Sex: Female, Male (Count of Participants)
Female	0 NaN	0 0%
Male	1 Infinity	1 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 NaN	0 0%
Not Hispanic or Latino	1 Infinity	1 100%
Unknown or Not Reported	0 NaN	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 NaN	0 0%
Asian	0 NaN	0 0%
Native Hawaiian or Other Pacific Islander	0 NaN	0 0%
Black or African American	0 NaN	0 0%
White	1 Infinity	1 100%
More than one race	0 NaN	0 0%
Unknown or Not Reported	0 NaN	0 0%
Region of Enrollment (participants) [Number]
United States	1 Infinity	1 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Needed for Feasibility
Description	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.
Time Frame	One month

Outcome Measure Data

Analysis Population Description

Biosamples that were collected were not analyzed as the analysis would be done once a proper batch of samples were collected. Given that never happened, investigators have no study results to report.

Arm/Group Title	Female Participants	Male Participants
Arm/Group Description	45 female patients will be screened to participate. 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.	45 male patients will be screened to participate 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.
Measure Participants	0	0

2. Primary Outcome

Title	Pre-Surgery and Post-Surgery Metabolic Signatures
Description	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.
Time Frame	One month post surgery

Outcome Measure Data

Analysis Population Description

Biosamples that were collected were not analyzed as the analysis would be done once a proper batch of samples were collected. Given that never happened, investigators have no study results to report.

Arm/Group Title	Female Participants	Male Participants
Arm/Group Description	45 female patients will be screened to participate. 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.	45 male patients will be screened to participate 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.
Measure Participants	0	0

3. Primary Outcome

Title	Pre-Surgery and Post-Surgery Microbial Signatures
Description	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.
Time Frame	One month post surgery

Outcome Measure Data

Analysis Population Description

Biosamples that were collected were not analyzed as the analysis would be done once a proper batch of samples were collected. Given that never happened, investigators have no study results to report.

Arm/Group Title	Female Participants	Male Participants
Arm/Group Description	45 female patients will be screened to participate. 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.	45 male patients will be screened to participate 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.
Measure Participants	0	0

4. Secondary Outcome

Title	Identification of Lung Cancer Stage Specific Signatures
Description	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.
Time Frame	One month post surgery

Outcome Measure Data

Analysis Population Description

Biosamples that were collected were not analyzed as the analysis would be done once a proper batch of samples were collected. Given that never happened, investigators have no study results to report.

Arm/Group Title	Female Participants	Male Participants
Arm/Group Description	45 female patients will be screened to participate. 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.	45 male patients will be screened to participate 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.
Measure Participants	0	0

5. Secondary Outcome

Title	Identification of Signatures Associated With Pulmonary Function
Description	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).
Time Frame	One month post surgery

Outcome Measure Data

Analysis Population Description

Biosamples that were collected were not analyzed as the analysis would be done once a proper batch of samples were collected. Given that never happened, investigators have no study results to report.

Arm/Group Title	Female Participants	Male Participants
Arm/Group Description	45 female patients will be screened to participate. 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.	45 male patients will be screened to participate 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.
Measure Participants	0	0

Adverse Events

Time Frame	4 weeks
Adverse Event Reporting Description	There were no female participants enrolled on this study before it was terminated.
Arm/Group Title	Female Participants		Male Participants
Arm/Group Description	45 female patients will be screened to participate. 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.		45 male patients will be screened to participate 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 Saliva Collection: Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes Blood Collection: Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube Urine Collection: Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers Tumor Collection: During surgical tumor removal, a tumor tissue sample will be collected 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.
All Cause Mortality
	Female Participants		Male Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)
Serious Adverse Events
	Female Participants		Male Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Female Participants		Male Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.