Collection of Sputum and Labeling for Lung Cancer

Part of paid clinical trials in Summit, New Jersey.

Sponsor
bioAffinity Technologies Inc.
Study ID
NCT03457415
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Mar 1, 2018
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Healthy Cohort
    Healthy Cohort: current non-smoker who has smoked less than 5 pack-years in his or her lifetime, and if smoked, quit more than 15 years ago, and has no known lung disease.
  • Arm: High-risk Cohort
    High-risk Cohort: individual aged ≥55-74 who is a current smoker with a smoking history of at least 30 pack-years or current non-smoker who has a smoking history of at least 30 pack-years and quit smoking within the past 15 years.
  • Arm: Cancer Cohort
    Cancer Cohort: individual who has been diagnosed by a physician as highly suspect for having lung cancer, but has not yet undergone a biopsy nor received therapy, and after providing a sputum sample is confirmed to have lung cancer by biopsy.

Primary Outcome Measure

Identification of Differential Characteristics [ Time Frame: 320 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Atlantic Respiratory InstituteSummitNew Jersey07901
Marissa Rienton-Lim, CCRC
[email protected]
908-934-0440
Robert Sussman, MD (PRINCIPAL_INVESTIGATOR)
Radiology Associates of AlbuquerqueAlbuquerqueNew Mexico87109
Timothy P. Zannes, JD
[email protected]
505-506-0853
Eugenio Rivera, MD (PRINCIPAL_INVESTIGATOR)
South Texas Veterans Health Care System (STVHCS)/Audie L. Murphy Memorial Veterans HospitalSan AntonioTexas78229
Jennifer Whitehead
[email protected]
210-834-1344
Sheila Habib, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Summit, NJ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Atlantic Respiratory Institute· Summit, NJRadiology Associates of Albuquerque· Albuquerque, NMSouth Texas Veterans Health Care System (STVHCS)/Audie L. Murphy Memorial Veterans Hospital· San Antonio, TX

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