18/12/2018 Using Pleural Effusions to Diagnose Cancer- ClinicalKey

UJI KLINIS

Menggunakan Efusi Pleura untuk Mendiagnosis Kanker

Pertama diterima pada 19 Oktober 2017. Terakhir diperbarui pada 27 Oktober 2017.

Tujuan
Efusi pleura (PE) adalah kondisi umum yang menandakan infeksi atau kanker. Para peneliti bertujuan untuk mengembangkan, memvalidasi, dan
prospektif menilai skor MAPED, skor klinis yang memprediksi keganasan saat masuk. Alat ini akan membantu dokter di seluruh dunia untuk dengan
cepat menilai kemungkinan efusi menjadi ganas dalam 4 jam setelah masuk.

Status Merekrut

Kondisi Efusi pleura

Tahap T/A

Jenis Studi Pengamatan

Judul Resmi Identifikasi klinis dari efusi pleura ganas di Departemen Darurat

Rincian studi lebih lanjut (sebagaimana disediakan oleh Institut Kesehatan Pusat Klinis Nasional (CC))

Pendaftaran 1080

Mulai tanggal 21 November 2013

Detil Deskripsi

https://www.clinicalkey.com/#!/content/clinical_trial/24-s2.0-NCT03319472 1/3
18/12/2018 Using Pleural Effusions to Diagnose Cancer- ClinicalKey

Background: Pleural effusions (PE) are common conditions that signal either pleural-disseminated infection or cancer. While these diagnoses bear
tremendous importance for patients, they require invasive procurement of pleural tissues and/or cells and time. Simple and rapid diagnostic markers
of pleural malignancy at admission that streamline diagnostic and treatment efforts remain unidentified. Objective: To develop, validate, and
prospectively assess markers of malignancy of PE at admission. Methods: A prospective cohort of patients with PE from different etiologies will be
recruited stating on 11.21.2013 and prospectively ending on 11.21.2023. Data will be collected within 4 hours of admission including history, chest X-
ray, and blood and pleural fluid (PF) cell counts and basic biochemistry. Pleural fluid and serum will be biobanked for future analyses. Patients will
sign informed consent forms. Diagnosis will be confirmed using standard microbiology, cytology, histology, and imaging techniques. Patients
undiagnosed within a month will be excluded. Variables will be entered into binary regression and receiver-operator analyses using malignancy as the
target to develop the MAPED score, a clinical score that predicts malignancy at admission. MAPED will be retrospectively validated in separate
published cohorts from the first therapeutic interventions in malignant effusion (TIME) 1-3 trials from Oxford UK. Data will be censored and analyzed
three times, at 40-month intervals since study initiation.

Eligibility

Minimum Age Eligible for Study: 18 Years

Maximum Age Eligible for Study: N/A

Genders Eligible for Study: All

Criteria
Inclusion Criteria: - Pleural effusion - Hospital admission - No previous pleural procedure - Age > 18 years - No previous chemoradiotherapy - No
antibiotic therapy during previous trimester - All history, chest X-ray, and pleural and blood cell counts and biochemistry entry data obtained within 4
hours after admission Exclusion Criteria: - No diagnosis at one month post-admission - No informed consent provided - Age < 18 years - History,
chest X-ray, or pleural and blood cell counts and biochemistry entry data obtained later than 4 hours after admission

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03319472

Locations

https://www.clinicalkey.com/#!/content/clinical_trial/24-s2.0-NCT03319472 2/3
18/12/2018 Using Pleural Effusions to Diagnose Cancer- ClinicalKey

Patras University Hospital

Status: Recruiting

Facility: Rio, Achaia, 26504, Greece

Sponsors and Collaborators

University of Patras

More Information

Other Publications

First Received: October 19, 2017

Last Updated: October 27, 2017

ClinicalTrials.gov Identifier: NCT03319472

ClinicalTrials.gov processed this data on November 06, 2017 Link to the current ClinicalTrials.gov record. (https://clinicaltrials.gov/show/NCT03319472)

Copyright © 2018 Elsevier, Inc. All rights reserved.

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