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Collection of Sputum and Labeling for Lung Cancer

Collection of Sputum and Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CyPath Lung, a test that checks sputum (mucus coughed up from the lungs) for lung cancer, against standard ways to find lung cancer. It includes healthy adults, adults at high risk for lung cancer, and adults with suspected lung cancer that is later confirmed. It also compares three ways to collect sputum from high-risk adults.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 21 or older.
  • Agree to share your primary care doctor's contact details and allow medical records to be shared if needed.
  • Meet the rules for one of the three groups below. A pack-year means smoking one pack a day for one year.
  • Healthy group: Do not smoke now, have smoked less than 5 pack-years total, and have no known lung disease. If you smoked before, you must have quit more than 15 years ago.
  • High-risk group: Be age 55–74 and have smoked at least 30 pack-years. You must smoke now or have quit within the past 15 years.
  • Cancer group: A doctor strongly suspects lung cancer, but you have not yet had a biopsy (a tissue test) or treatment. After you give sputum, a biopsy must confirm lung cancer.

Who can't join

  • Have severe lung disease that blocks airflow and cannot cough hard enough to give a sputum sample. Lung disease alone does not rule you out if you can give a sample.
  • Have angina (chest pain caused by low blood flow to the heart) with even slight activity.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Each subject must meet the following criteria to be enrolled in this study: * 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 * Meet requirements of one of three cohorts in the study: 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. 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. 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. Exclusion Criteria: 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. 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

Study sites (3)

NJ

NM

TX