Diagnostic Study for Lung Cancer Detection Test

NCT01700452 | Completed

• 2 other identifiers: LCD Test 17Jul2012Revision 3
• Study Type: observational
• Target: 173
• Locations: 2 countries
• Sites: 6

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.

Conditions

Lung Cancer

Keywords

Lung cancer; Pulmonary nodules; FISH Test

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioview, Inc.: lead

Study Sites (6)

VA Greater Los Angeles Health System

Los Angeles, California, 90073, United States

Location

Frederick Memorial Hospital, Regional Cancer Center

Frederick, Maryland, 21701, United States

Location

St. Luke's Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Sheba Medical Center Thoracic Cancer Research and Detection Center

Tel Litwinsky, 52621, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum specimens, fixed and stained for diagnostic testing

MeSH Terms

Conditions

Lung Neoplasms; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alan Schwebel, PhD

  Bioview, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: October 4, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 19, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); IL (3)