Clinical trial NCT01700452: Diagnostic Study for Lung Cancer Detection Test
Official title: Clinical Study of BioView Target -FISH Lung Cancer Detection Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung cancer
Pulmonary nodules
FISH Test
Lead sponsor: Bioview, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects will be selected from pulmonary clinics and physician's practice in community hospital settings.

Brief summary: 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.

Detailed description: 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.

The results of the test will not be provided to the subject, the investigator and will not be used to diagnose or treat the subject.

Eligibility criteria: 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.

Primary outcomes:
measure: Determination of concordance of the Target-Fish LCD Test and diagnosis by biopsy
timeFrame: 2 weeks following sputum collection
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Health System
state: California
city: Frederick
country: United States
facility: Frederick Memorial Hospital, Regional Cancer Center
state: Maryland
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center Thoracic Cancer Research and Detection Center
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Bioview, Inc.
name: Alan Schwebel, PhD
role: STUDY_DIRECTOR
References: