Diagnostic Study for Lung Cancer Detection Test

Completed

• Conditions: Lung Cancer

• Registration Number: NCT01700452
• Lead Sponsor: Bioview, Inc.

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of concordance of the Target-Fish LCD Test and diagnosis by biopsy	2 weeks following sputum collection	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.

Trial Locations

Locations (6)

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel

St. Luke's Hospital; 🇺🇸 Bethlehem, Pennsylvania, United States

VA Greater Los Angeles Health System; 🇺🇸 Los Angeles, California, United States

Kaplan Medical Center; 🇮🇱 Rehovot, Israel

Sheba Medical Center Thoracic Cancer Research and Detection Center; 🇮🇱 Tel Hashomer, Israel

Frederick Memorial Hospital, Regional Cancer Center; 🇺🇸 Frederick, Maryland, United States