Diagnostic Study for Lung Cancer Detection Test

Clinical Study of BioView Target -FISH 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 Overview

• Status: Completed
• Conditions: Lung Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• Israel
  • Rehovot, Israel, 76100
    • Kaplan Medical Center
  • Tel Hashomer, Israel, 52621
    • Sheba Medical Center Thoracic Cancer Research and Detection Center
  • Tel-Aviv, Israel, 64239
    • Tel-Aviv Sourasky Medical Center
• United States
  • California
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Health System
  • Maryland
    • Frederick, Maryland, United States, 21701
      • Frederick Memorial Hospital, Regional Cancer Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subjects will be selected from pulmonary clinics and physician's practice in community hospital settings.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bioview, Inc.
• Investigators: Study Director: Alan Schwebel, PhD, Bioview, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: September 10, 2012
• First Submitted That Met QC Criteria: October 3, 2012
• First Posted (Estimate): October 4, 2012

Study Record Updates

• Last Update Posted (Estimate): July 19, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Lung cancer; Pulmonary nodules; FISH Test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LCD Test 17Jul2012; Revision 3 (Other Identifier: BioView, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No