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A prospective, single-centre, diagnostic accuracy study of XpertMTB/RIF Ultra to differentiate atypical tuberculosis from sarcoidosis

A prospective, single-centre, diagnostic accuracy study of XpertMTB/RIF Ultra to differentiate atypical tuberculosis from sarcoidosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036043
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sarcoidosis, tuberculosis

Interventions

Gold Standard:Biopsy pathological specimen, and sputum AFB smear
Index test:XpertMTB/RIF Ultra

Sponsors

Shanghai Pulmonary Hospital Tongji University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
positive;negative;SPE, SEN, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactQiuhong Li

Shanghai Pulmonary Hospital Tongji University, School of Medicine

qiuhongl@126.com+86 18721740608

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026