Viewing Study NCT02175134



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Last Modification Date: 2024-10-26 @ 11:26 AM
Study NCT ID: NCT02175134
Status: TERMINATED
Last Update Posted: 2018-08-29
First Post: 2014-06-25

Brief Title: IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
Sponsor: Asan Medical Center
Organization: Asan Medical Center

Study Overview

Official Title: IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
Status: TERMINATED
Status Verified Date: 2018-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: low enrollment rate
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The diagnosis of tuberculous peritonitis TBP is still challenging and largely dependent on invasive procedures such as laparoscopy A recently developed RD-1 gene-based assay for diagnosing TBP shows has given promising results The investigators thus created a 2-step algorithm using the BloodAscites ELISPOT assays and adenosine deaminase ADA in ascites for differentiation of TBP from other diagnoses Blood ELISPOT 6 spots or ADA 21 UL as a rule-out test and AscitesBlood ratio 3 as a rule-in test This study is the randomized controlled trial on whether this 2-step algorithm-based approach can reduce the laparoscopic biopsy for the diagnosis of TBP in patients with suspected TBP
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None