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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Arizona
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Tucson, Arizona, 미국, 85713
- 모병
- Banner University Medical Center South
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연락하다:
- Trina Hughes
- 전화번호: 520-626-9372
- 이메일: tdhughes@arizona.edu
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Tucson, Arizona, 미국, 85719
- 모병
- Banner University Medical Center Tucson
-
연락하다:
- Trina Hughes
- 전화번호: 520-626-9372
- 이메일: tdhughes@arizona.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Adult patients that are having pleural fluid drained as part of clinical care.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
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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. |
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Indeterminate pleural effusions
Patients with a known cancer diagnosis, but with cytology negative pleural fluid. |
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Malignant pleural effusions
Patients with known cancer and a cytology positive pleural fluid sample. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diagnostic performance
기간: From enrollment to the completion of the study analysis an average of 2 years
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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
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Predictive value
기간: From enrollment to 1 year post procedure
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Investigators will evaluate the association of the methylation signal from the EPISEEK-MPE test with overall survival. |
From enrollment to 1 year post procedure
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Validate EPISEEK-MPE
기간: From enrollment to the completion of the study analysis
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Establish the performance specifications of EPISEEK-MPE as a laboratory developed test including:
|
From enrollment to the completion of the study analysis
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Methylation signal
기간: At baseline
|
Determine the methylation signal relationship with clinical variables such as age, race, gender, and ethnicity. |
At baseline
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IRB # 2012283169
- 1R44CA287829-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
This is an exploratory study with a commercial entity and data is considered joint intellectual property.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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