Diagnostic Study for Lung Cancer Detection Test
This study is currently recruiting participants.
Verified October 2012 by Bioview, Inc.
Sponsor:
Bioview, Inc.
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
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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 May 21, 2013