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Clinical Study of BioView Target -FISH Lung Cancer Detection Test

18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Clinical Study of BioView Target -FISH Lung Cancer Detection Test

Inclusion Criteria:

- Subjects with 0.8-3 cm solitary pulmonary nodules with high probability for

- 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

Exclusion Criteria:

- 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

- 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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Determination of concordance of the Target-Fish LCD Test and diagnosis by biopsy

Outcome Description:

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.

Outcome Time Frame:

2 weeks following sputum collection

Safety Issue:


Principal Investigator

Alan Schwebel, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Bioview, Inc.


United States: Institutional Review Board

Study ID:

LCD Test 17Jul2012



Start Date:

April 2012

Completion Date:

April 2015

Related Keywords:

  • Lung Cancer
  • Lung cancer
  • Pulmonary nodules
  • FISH Test
  • Lung Neoplasms



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