Diagnostic Study for Lung Cancer Detection Test

This study is currently recruiting participants.
Verified October 2012 by Bioview, Inc.
Sponsor:
Information provided by (Responsible Party):
Bioview, Inc.
ClinicalTrials.gov Identifier:
NCT01700452
First received: September 10, 2012
Last updated: March 6, 2013
Last verified: October 2012
  Purpose

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.


Condition
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 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700452

Locations
United States, California
Providence-St. Joseph Health Systems, Disney Family Cancer Center Recruiting
Burbank, California, United States, 91505
Contact: Ann Kang    818-748-4726    ann.kang@providence.org   
Principal Investigator: Jose Esteban, MD         
VA Greater Los Angeles Health System Recruiting
Los Angeles, California, United States, 90073
Contact: Guy Soo-Hoo, MD    310-268-3021    guy.soohoo@va.gov   
Principal Investigator: Raj Batra, MD         
United States, Louisiana
Lafayette General Medical Center/Horizon Research Recruiting
Lafayette, Louisiana, United States, 70503
Contact: Yesenia Leach    337-255-6349    yesenia@horizonresearchgroup.com   
Principal Investigator: Gary Guidry, MD         
United States, Maryland
Frederick Memorial Hospital, Regional Cancer Center Recruiting
Frederick, Maryland, United States, 21701
Contact: Shelley Francella    301-668-7043    sfrancella@fmh.org   
Principal Investigator: Mark Soberman, MD         
United States, Pennsylvania
St. Luke's Hospital Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Kathleen Lear, RN    484-526-6038    leark@slhn.org   
Principal Investigator: William Burfeind, Jr., MD         
Israel
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Contact: Tali Levi    972 8 9441048    talile@clalit.org.il   
Principal Investigator: Gershon Fink         
Sheba Medical Center Thoracic Cancer Research and Detection Center Recruiting
Tel Hashomer, Israel, 52621
Contact: Tali Levi    972 3 5307009    meitale26@gmail.com   
Principal Investigator: Nir Peled, MD PhD FCCP         
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Contact: Zipi Yemini    03-6973591    jemini_zipi@hotmail.com   
Principal Investigator: Yehuda Schwarz, MD         
Sponsors and Collaborators
Bioview, Inc.
Investigators
Study Director: Alan Schwebel, PhD Bioview, Inc.
  More Information

No publications provided

Responsible Party: Bioview, Inc.
ClinicalTrials.gov Identifier: NCT01700452     History of Changes
Other Study ID Numbers: LCD Test 17Jul2012, Revision 3
Study First Received: September 10, 2012
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board
Israel: Ministry of Health

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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 21, 2014