Diagnostic Study for Lung Cancer Detection Test

Completed

Conditions studied: Lung Cancer

In brief

Early detection of lung cancer and early removal of the cancer nodules facilitates the diagnosis and treatment. However, not all nodules are malignant. Currently the standard method to diagnose lung cancer is to remove any suspicious nodules from the lung in a surgical procedure. This study is being conducted to evaluate the performance of a laboratory test to detect changes in lung cells that might be an early indicator of lung cancer. The test uses mucus (sputum) which is collected in a non-invasive method. This study will compare the results of the lung biopsy with the laboratory test to determine if the test can detect cancer or the lack of cancer. The laboratory test will not be shared with the treating physician or the patient as the current standard for lung cancer diagnosis is a biopsy. Approximately 330 patients will be enrolled in the study. There is one visit involved and includes the collection of a sputum specimen by coughing into a cup. The medical records of patients who are negative for cancer by biopsy will be reviewed for 2 years to detect any changes in diagnosis.

Key facts

Study ID

NCT01700452

Run by

Bioview, Inc.

People needed

173

Starts

2012-04-01

Expected to finish

2016-04-01

Last updated by the study team

2016-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with 0.8-3 cm solitary pulmonary nodules with high probability for malignancy
• Candidate is scheduled to undergo lung biopsy procedure to determine clinical diagnosis, such as Bronchoscope biopsy, Electromagnetic Navigation Bronchoscopy, fiber optic Bronchoscopy, Needle biopsy, CT guided, Percutaneous Transthoracic Needle biopsy, Transthoracic Needle Biopsy, Open biopsy for Diagnostic Resection or Video-Assisted Thorascopic Surgery.
• Candidate who is capable of undergoing sputum induction.
• Ability to understand the investigational nature of the study and sign the informed consent.

You may not qualify if…

• Subjects who pose a high clinical risk for diagnostic bronchoscopy or transthoracic biopsy for definitive diagnosis.
• Subjects already diagnosed with lung cancer, or previously treated for lung cancer.
• Subjects who experienced pneumonia within last 12 weeks.
• Subjects who experienced an acute respiratory infection within the last 2 weeks
• Cases without sufficient documentation of diagnosis or follow-up will not be included.
• Treatment for, or evidence of any cancer other than nonmelanoma skin cancer or carcinoma in situ within the last 3 years.
• Subject who lack the capacity to consent.

Where it is running

• Tel-Aviv Sourasky Medical Center — Tel Aviv, Israel
• Sheba Medical Center Thoracic Cancer Research and Detection Center — Tel Litwinsky, Israel
• VA Greater Los Angeles Health System — Los Angeles, California, United States
• Frederick Memorial Hospital, Regional Cancer Center — Frederick, Maryland, United States
• St. Luke's Hospital — Bethlehem, Pennsylvania, United States
• Kaplan Medical Center — Rehovot, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.