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Diagnostic Study for Lung Cancer Detection Test

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bioview, Inc. Identifier:
First received: September 10, 2012
Last updated: August 20, 2015
Last verified: August 2015

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.

Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Study of BioView Target -FISH Lung Cancer Detection Test

Resource links provided by NLM:

Further study details as provided by Bioview, Inc.:

Primary Outcome Measures:
  • 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
sputum specimens, fixed and stained for diagnostic testing

Estimated Enrollment: 330
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects will be selected from pulmonary clinics and physician's practice in community hospital settings.

Inclusion Criteria:

  • 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.

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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
Sponsors and Collaborators
Bioview, Inc.
Study Director: Alan Schwebel, PhD Bioview, Inc.
  More Information

Responsible Party: Bioview, Inc. Identifier: NCT01700452     History of Changes
Other Study ID Numbers: LCD Test 17Jul2012  Revision 3 
Study First Received: September 10, 2012
Last Updated: August 20, 2015
Health Authority: United States: Institutional Review Board
Israel: Ministry of Health

Keywords provided by Bioview, Inc.:
Lung cancer
Pulmonary nodules

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on May 25, 2016