Collection of Sputum and Labeling for Lung Cancer
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorbioAffinity Technologies Inc.
About this trial
The primary objective of this study is to compare Assay results to diagnoses determined by currently accepted standards for lung cancer detection. This will be accomplished by analysis of sputum samples from three cohorts including healthy Participants, high risk Participants, and cancer patient Participants using the Assay as developed in accordance with findings of bioAffinity protocol BA-001 to confirm assay results. Adjustments will be made as necessary to finalize Assay design for clinical trials and commercialization.
The secondary objective of this study is to determine optimum methods for collection of sputum samples. Three sputum collection methods used by high risk Participants will be compared. Individuals at high risk for lung cancer will be assigned to one of three sputum collection cohorts including (1) acapella® airway assist device under medical supervision to obtain a single sputum sample; (2) acapella® airway assist device to obtain a sputum sample over a three-day period, and (3) individuals who under medical supervision will collect a single sputum sample assisted by nebulization of between 0.9% to 10% hypertonic saline. Samples will be compared to determine the optimal collection method for sample analysis by CyPath® Lung.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female
21 years of age or older
Willing to provide primary care physician contact information to the investigator and agree to have medical information released if indicated
Disqualifiers
Severe obstructive lung disease and unable to cough with sufficient exertion to produce a sputum sample. Participants with lung disease that are able to cough with sufficient exertion to produce a sputum sample are not excluded from the study
Angina with minimal exertion
Pregnancy
Trial population
Study Population: Male and female Participants, 21 years of age or older, who meet the requirements of one of three cohorts described below: * Healthy Cohort * High-risk Cohort * Cancer Cohort Participants who meet any of the following criteria will be excluded from the study: * Severe obstructive lung disease and unable to cough with sufficient exertion to produce a sputum sample due to lung disease. Participants with lung disease that are able to cough with sufficient exertion to produce a sputum sample are not excluded from the study. * Currently undergoing treatment for cancer. Participants who are on long-term medications used for treatment and/or prevention of cancer, such as Tamoxifen for breast cancer, are not excluded. * Angina with minimal exertion * Pregnancy
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 3 trial groupsGroup A: Healthy Cohort
Group B: High-risk Cohort
Group C: Cancer Cohort
Trial outcomes
Primary outcomes
1
Identification of Differential Characteristics
The primary outcome measure is to identify differential characteristics (using flow cytometry for high-throughput screening of Assay labeled sputum samples) between samples taken from healthy Participants, Participants at high risk for lung cancer who are free of the disease, and Participants with confirmed lung cancer.
Time frame
320 daysSecondary outcomes
1
Sputum Collection Methodology
The secondary endpoint is evaluation of the suitability of sputum samples collected by the three different methods.
Time frame
320 daysSponsors and contacts
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Source ClinicalTrials.gov