The detection of mycobacterium tuberculosis via FFPE samples

The detection of mycobacterium tuberculosis via FFPE samples (digital PCR)

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000032388

Enrollment

Unknown

Registered

2020-04-27

Start date

2021-01-01

Completion date

Unknown

Last updated

2020-04-27

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

Conditions

tuberculosis

Interventions

Gold Standard:The identification of mycobacteria by Ziehl–Neelsen (ZN) staining of formalin-fixed and paraffin-embedded (FFPE) samples

Index test:identification&#32

of&#32

mycobacteria&#32

DNA&#32

by&#32

ddPCR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Those patients with samples that confirmed as a sample of granulomatous disease; 2. The samples were collected as Formalin-fixed and Paraffin-embedded (FFPE) samples; 3. Patients with informed consent and voluntary subjects (children under the age of 18 need the signature of legal guardian at the same time).

Exclusion criteria

Exclusion criteria: 1) The collection time or case information of the samples are unclear; 2) The sample size is not sufficient for the detection; 3) The period of storage time is limited to 24 months.

Design outcomes

Primary

Measure	Time frame
MTC DNA;NTM;SEN, SPE, ACC, AUC of ROC;	—

Countries

China

Contacts

Public ContactChunyan Wu

Shanghai Pulmonary Hospital

wuchunyan518@sina.com+86 18017729697

Outcome results

None listed

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