Clinical trial: Breath Test for Early Detection of Lung Cancer (NCT00639067)

Eligibility criteria:
Group 1 - Asymptomatic High Risk Subjects

        Inclusion criteria

          1. Patient is willing and able to cooperate with study and give signed informed consent
             to participate.

          2. Patient has had (or will have) chest imaging with spiral CT within 7 days of breath
             test.

          3. Age at least 18 years.

          4. History of at least 10 pack-years of cigarette smoking.

          5. Provide written informed consent prior to admission into the study.

        Exclusion criteria

        1. Previously documented history of cancer of any site.

        Group 2 - Symptomatic High Risk Subjects Without a Tissue Diagnosis

        Inclusion criteria

          1. Patient is willing and able to cooperate with study and give signed informed consent
             to participate.

          2. Patient does not have a tissue diagnosis of pulmonary disease.

          3. Patient is undergoing evaluation for an unexplained pulmonary illness which is
             clinically consistent with lung cancer. This includes patients with unexplained
             symptoms (e.g. chronic unexplained cough or hemoptysis), unexplained signs (e.g.
             weight loss, lymphadenopathy) or unexplained investigations (e.g. an abnormal chest
             x-ray).

          4. Actively smoking patients, as well as never smokers and former smokers are eligible
             for the study so long as a complete smoking consumption history can be recorded.

        Exclusion criteria

        1. Previously documented history of cancer of any other site.

        Group 3 - Symptomatic High Risk Subjects with a Tissue Diagnosis

        Inclusion criteria

          1. Patient is willing and able to cooperate with study and give signed informed consent
             to participate.

          2. Patient has a tissue diagnosis of a. lung cancer. or b. pulmonary disease other than
             lung cancer e.g. sarcoidosis, COPD, or pulmonary infection.

          3. A diagnosis of lung cancer is defined as cytologic or histologic confirmation of lung
             cancer by bronchoscopic/thoracoscopic means, sputum cytology, percutaneous fine needle
             aspiration biopsy. Patients may have either non-small cell lung cancer or small cell
             lung cancer.

          4. Breath VOC collection will be obtained prior to any invasive procedure e.g.
             thoracotomy, mediastinoscopy or mediastinotomy.

          5. Actively smoking patients, as well as never smokers and former smokers are eligible
             for the study so long as a complete smoking consumption history can be recorded.

        Exclusion criteria

        1. Previously documented history of cancer of any other site.

        Group 4 - Apparently healthy subjects

        Inclusion criteria

          1. Willingness to follow protocol requirements as evidenced by written, informed consent.

          2. Healthy, male or female subjects, ages 18 and older.

          3. Subjects who are non smokers having no signs or symptoms of lung carcinoma

        Exclusion Criteria

        1. Any active ongoing medical problems.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? 1