Clinical Study of BioView Target -FISH Lung Cancer Detection Test
Observational
Observational Model: Cohort, Time Perspective: Prospective
Determination of concordance of the Target-Fish LCD Test and diagnosis by biopsy
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.
2 weeks following sputum collection
No
Alan Schwebel, PhD
Study Director
Bioview, Inc.
United States: Institutional Review Board
LCD Test 17Jul2012
NCT01700452
April 2012
April 2015
Name | Location |
---|---|
St. Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Providence-St. Joseph Health Systems, Disney Family Cancer Center | Burbank, California 91505 |
VA Greater Los Angeles Health System | Los Angeles, California 90073 |
Lafayette General Medical Center/Horizon Research | Lafayette, Louisiana 70503 |
Frederick Memorial Hospital, Regional Cancer Center | Frederick, Maryland 21701 |