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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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31 August 2020 |
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Main ID: |
ChiCTR2000036043 |
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Date of registration:
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2020-08-21 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A prospective, single-centre, diagnostic accuracy study of XpertMTB/RIF Ultra to differentiate atypical tuberculosis from sarcoidosis
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Scientific title:
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A prospective, single-centre, diagnostic accuracy study of XpertMTB/RIF Ultra to differentiate atypical tuberculosis from sarcoidosis |
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Date of first enrolment:
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2020-10-01 |
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Target sample size:
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Target condition:72;Difficult condition:72 |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=59045 |
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Study type:
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Diagnostic test |
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Study design:
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Factorial
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Qiuhong Li
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Address:
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507 Zhengmin Road, Yangpu District, Shanghai, China
200433
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Telephone:
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+86 18721740608 |
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Email:
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qiuhongl@126.com |
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Affiliation:
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Shanghai Pulmonary Hospital Tongji University, School of Medicine |
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Name:
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Qiuhong Li
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Address:
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507 Zhengmin Road, Yangpu District, Shanghai, China
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Telephone:
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+86 18721740608 |
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Email:
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qiuhongl@126.com |
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Affiliation:
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Shanghai Pulmonary Hospital Tongji University, School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Male or female, aged 18 to 80 years old;
2. Patients with mediastinal or / and hilar lymphadenopathy found by chest CT
3.suspected intrathoracic granulomatous lymphadenopathies diagnosed by two physicians specialized in pulmonary diseases based on patient clinical and radiological (examined by two radiologists)
4.negative sputum AFB smear (at least for three times before the bronchoscopy);
5.No evidence of tumor was found in sputum and other body fluids before biopsy;
6.Patients must be able to fully understand the informed consent form, agree to participate in the study and sign the informed consent form.
Exclusion criteria: 1.Patients who have been anti tuberculosis therapy in the past;
2.Patients who have been confirmed with malignancy by lung puncture and other means;
3.Patients who was suspected with tumor by clinical and imaging;
4.Patients who was considered with infection other than tuberculosis;
5.The patients who were judged by the physician in charge of the trial or the physician in charge of the trial as not suitable for this trial;
6.Patients who are not suitable for obtaining pathological tissue specimens.
Age minimum:
18
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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sarcoidosis, tuberculosis
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Intervention(s)
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Gold Standard:Biopsy pathological specimen, and sputum AFB smear;Index test:XpertMTB/RIF Ultra;
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Primary Outcome(s)
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positive;negative;SPE, SEN, ACC, AUC of ROC;
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Source(s) of Monetary Support
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research funding
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Ethics review
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Status: Approved
Approval date: 19/08/2020
Contact:
Gui Tao
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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