Diagnostic Study for Lung Cancer Detection Test
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/20/2016 |
| Start Date: | April 2012 |
| End Date: | April 2016 |
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.
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.
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.
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.
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.
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