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The study for diagnostic value of transbronchial mediastinal cryobiopsy combined with next generation sequencing in mediastinal lesions

The study for diagnostic value of transbronchial mediastinal cryobiopsy combined with next generation sequencing in mediastinal lesions

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100045786
Enrollment
Unknown
Registered
2021-04-25
Start date
2021-04-25
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

Mediastinal Lesion

Interventions

Index test:Second-generation&#32
gene&#32
sequencing

Sponsors

Xinqiao Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged >=15 years; 2.Patients with more than one mediastinal lesions with diameter >= 5mm was detected by thoracic CT; 3.Patients with recently discovered mediastinal lesions, clinical respiratory symptoms of cough, expectoration, thoracalgia apnea or complicated lung lesions implicated by thoracic image, which indicates the need of biopsy to identify the etiology; 4.Patients who have undergone necessary preoperative laboratory examinations and thoracic CT or other examinations such as cardiac Color Doppler ultrasound and CTA when necessary; 5.Patients who are informed and informed consent form are acquired.

Exclusion criteria

Exclusion criteria: 1.Patients with contradictions to endoscopic examination like severe cardio-pulmonary diseases, coagulation disorders, intolerance to asthenia are complicated; 2.Conditions when fail to detect the lesions in ultrasonic landscape within 20 minutes; 3.Conditions when abundant blood flow, adjacent large vessels or other conditions are detected by ultrasonic landscape which indicates high risks to continue the biopsy; 4.Patients with psychiatric disorders or severe neurosis; 5.Patients who have been involved in other clinical experiments in recent 3 months; 6.Any other conditions considered to be inappropriate to be involved in this study.

Design outcomes

Primary

MeasureTime frame
Diagnostic Sensitivity;Diagnostic Accuracy;Microbiome Diversity;

Countries

China

Contacts

Public ContactFan Ye

Xinqiao Hospital, Third Military Medical University

83728087@qq.com+86 13983815728

Outcome results

None listed

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