A Study to Establish the Diagnostic Value of the EPISEEK-MPE Liquid Biopsy Assay to Identify Cancer in Pleural Effusion Samples. (EPISEEK-MPE)
Development of a Molecular Assay to Diagnose Malignant Pleural Effusions
The goal of this study is to evaluate the EPISEEK-MPE laboratory test for diagnosis of malignant (cancerous) pleural effusions verses pleural effusions caused by a non-cancer condition. The study uses excess samples drained from around the lung as part of a patient's regular care. The main questions the study aims to answer are:
- Is the EPISEEK-MPE test reliable to detect cancer cells and aid in the diagnosis of malignant pleural effusions?
- Do age, race, gender and ethnicity change the reliability of the EPISEEK-MPE test?
- Can the results of the EPISEEK-MPE test predict which patients have a better chance of survival than others?
Participants will be asked to donate a small portion of the excess fluid drained from around the lung for research. Participants will also give permission to collect data from the medical records.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
In clinical practice, it remains a challenge to distinguish between malignant pleural effusion (MPE) and benign pleural effusion (BPE). Because of the limitations of conventional cytology methods, there is an urgent need to develop a more accurate and effective method for the efficient diagnosis of MPE. In collaboration with the University of Arizona, Precision Epigenomics has developed the EPISEEK-MPE test that has the potential to be an effective complimentary tool for cytology in the process of differential diagnosis. The aim of this project is to conduct a multi-site clinical validation study to establish the EPISEEK-MPE test as a new commercial molecular test for the diagnosis of malignant pleural effusions. The study will: 1) Establish the diagnostic value of the EPISEEK_MPE liquid biopsy assay to identify cancer in pleural effusion and 2) Validate the EPISEEK-MPE liquid biopsy assay for cancer detection in pleural effusion. The long-term goal of this project is to bring the field of pathology a new diagnostic tool for the diagnosis of malignant pleural effusions.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
-
-
Arizona
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Tucson, Arizona, Förenta staterna, 85713
- Rekrytering
- Banner University Medical Center South
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Kontakt:
- Trina Hughes
- Telefonnummer: 520-626-9372
- E-post: tdhughes@arizona.edu
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Tucson, Arizona, Förenta staterna, 85719
- Rekrytering
- Banner University Medical Center Tucson
-
Kontakt:
- Trina Hughes
- Telefonnummer: 520-626-9372
- E-post: tdhughes@arizona.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Adult patients that are having pleural fluid drained as part of clinical care.
Beskrivning
Inclusion Criteria:
- Adult patients having pleural fluid drained for clinical care (thoracentesis or chest tube placement)
- Consent to have pleural fluid sample used for research
Exclusion Criteria:
- Insufficient fluid available following clinical drainage procedure
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
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Benign pleural effusions
Patients with pleural effusions due to infection, heart failure, atelectasis, bronchial obstruction, pulmonary embolism, etc. To be included in the benign group, subjects cannot have any cancer-related history within the last 15 years and chest radiograph will be without evidence of lung mass / malignancy. |
|
Indeterminate pleural effusions
Patients with a known cancer diagnosis, but with cytology negative pleural fluid. |
|
Malignant pleural effusions
Patients with known cancer and a cytology positive pleural fluid sample. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic performance
Tidsram: From enrollment to the completion of the study analysis an average of 2 years
|
To determine the diagnostic performance characteristics of the EPISEEK-MPE test in terms of accuracy, specificity, sensitivity, negative predictive value (NPV), and positive predictive value (PPV). |
From enrollment to the completion of the study analysis an average of 2 years
|
|
Predictive value
Tidsram: From enrollment to 1 year post procedure
|
Investigators will evaluate the association of the methylation signal from the EPISEEK-MPE test with overall survival. |
From enrollment to 1 year post procedure
|
|
Validate EPISEEK-MPE
Tidsram: From enrollment to the completion of the study analysis
|
Establish the performance specifications of EPISEEK-MPE as a laboratory developed test including:
|
From enrollment to the completion of the study analysis
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Methylation signal
Tidsram: At baseline
|
Determine the methylation signal relationship with clinical variables such as age, race, gender, and ethnicity. |
At baseline
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB # 2012283169
- 1R44CA287829-01A1 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
This is an exploratory study with a commercial entity and data is considered joint intellectual property.
Läkemedels- och apparatinformation, studiedokument
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