Diagnostic Study for Lung Cancer Detection Test
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Rehovot, Israel, 76100
- Kaplan Medical Center
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Tel Hashomer, Israel, 52621
- Sheba Medical Center Thoracic Cancer Research and Detection Center
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Tel-Aviv, Israel, 64239
- Tel-Aviv Sourasky Medical Center
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California
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Los Angeles, California, Vereinigte Staaten, 90073
- VA Greater Los Angeles Health System
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Maryland
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Frederick, Maryland, Vereinigte Staaten, 21701
- Frederick Memorial Hospital, Regional Cancer Center
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Pennsylvania
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Bethlehem, Pennsylvania, Vereinigte Staaten, 18015
- St. Luke's Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Determination of concordance of the Target-Fish LCD Test and diagnosis by biopsy
Zeitfenster: 2 weeks following sputum collection
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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.
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2 weeks following sputum collection
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Alan Schwebel, PhD, Bioview, Inc.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LCD Test 17Jul2012
- Revision 3 (Andere Kennung: BioView, Inc.)
Plan für individuelle Teilnehmerdaten (IPD)
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