Diagnostic Study for Lung Cancer Detection Test
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Clinical Study of BioView Target -FISH Lung Cancer Detection Test|
- Determination of concordance of the Target-Fish LCD Test and diagnosis by biopsy [ Time Frame: 2 weeks following sputum collection ] [ Designated as safety issue: No ]Subjects suspected of having of having lung cancer and who are to undergo biopsy will undergo sputum sampling. The sputum will be assayed using the BioView test kit. Biopsy results will be compared with the assay results, each being a dichotomous response (positive or negative for cancer by biopsy, positive or negative assay result using client-supplied cut-off). Since the assay may detect cancer before a biopsy is positive or because the sputum sampling may be more representative of the condition of the lung than just the biopsied nodule, it will be necessary to follow thte negative biopsy subjects for up to two years to either rule in or rule out lung cancer.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
patients suspected of having lung cancer
Subjects presenting with 0.8 - 3 cm solitary pulmonary nodules with high probability for malignance. The subject must be scheduled for a lung biopsy procedure to determine clinical diagnosis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700452
|United States, California|
|VA Greater Los Angeles Health System|
|Los Angeles, California, United States, 90073|
|United States, Maryland|
|Frederick Memorial Hospital, Regional Cancer Center|
|Frederick, Maryland, United States, 21701|
|United States, Pennsylvania|
|St. Luke's Hospital|
|Bethlehem, Pennsylvania, United States, 18015|
|Kaplan Medical Center|
|Rehovot, Israel, 76100|
|Sheba Medical Center Thoracic Cancer Research and Detection Center|
|Tel Hashomer, Israel, 52621|
|Tel-Aviv Sourasky Medical Center|
|Tel-Aviv, Israel, 64239|
|Study Director:||Alan Schwebel, PhD||Bioview, Inc.|