Suspected Tuberculous PeritonitisNCT02175134
IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
A study testing Blood and Ascites ELISPOT in people with Suspected Tuberculous Peritonitis, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Suspected Tuberculous Peritonitis
- What is being tested?
- Blood and Ascites ELISPOT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients with suspected tuberculous peritonitis
- age 16 or more
- formal informed consent
Who cannot join
- not specified
Trial locations and contacts
1 site in 1 country.
About this study
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 Blood/Ascites ELISPOT assays and adenosine deaminase (ADA) in ascites for differentiation of TBP from other diagnoses (Blood ELISPOT ≥6 spots or ADA ≥ 21 U/L' as a rule-out test and 'Ascites/Blood 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.
- Conditions
- Suspected Tuberculous Peritonitis
- Being tested
- Blood and Ascites ELISPOT
- Keywords
- tuberculosis, peritonitis, laparoscopy
- Medical subject headings
- Tuberculosis, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and Ascites ELISPOTOther
| Study group | Role | What they receive |
|---|---|---|
| conventional diagnostic flow arm | No intervention | Perform the laparoscopic biopsy as a discretion of attending physician's decision |
| two-step algorithm-based approach | Experimental | Perform the laparoscopic biopsy as a discretion of attending physician's decision, but if the below conditions are met, do not perform the laparoscopic biopsy.
1. Blood ELISPOT >= 6 spots or ascites adenosine deaminase > 20 IU/L, and
2. Ascites ELISPOT/Blood ELISPOT rato > 3 Receives: Other: Blood and Ascites ELISPOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
the frequency of laparoscopic biopsy
Measured: 1 week after the enrollment
Secondary outcomes (1)
the frequency of correct or wrong diagnosis
the frequency of correct or wrong diagnosis
Measured: 6 months after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: low enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected Tuberculous PeritonitisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Han Kim, Asan Medical Center
- Investigators
- Sung-Han Kim, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175134
- Sponsor's protocol ID
- 2014-0616
- Status last verified
- Aug 2018
- First submitted
- 25 Jun 2014
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
- ClinicalTrials.gov ID
- NCT02175134
- Acronym / sponsor ID
- 2014-0616
- Conditions
- Suspected Tuberculous Peritonitis
- Keywords
- tuberculosis, peritonitis, laparoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment rate
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Blood/Ascites ELISPOT assays and adenosine deaminase (ADA) in ascites for differentiation of TBP from other diagnoses (Blood ELISPOT ≥6 spots or ADA ≥ 21 U/L' as a rule-out test and 'Ascites/Blood 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional diagnostic flow arm | No intervention | –Perform the laparoscopic biopsy as a discretion of attending physician's decision |
| two-step algorithm-based approach | Experimental | Other: Blood and Ascites ELISPOTPerform the laparoscopic biopsy as a discretion of attending physician's decision, but if the below conditions are met, do not perform the laparoscopic biopsy. 1. Blood ELISPOT >= 6 spots or ascites adenosine deaminase > 20 IU/L, and 2. Ascites ELISPOT/Blood ELISPOT rato > 3 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- all patients with suspected tuberculous peritonitis
- age 16 or more
- formal informed consent
Key exclusion criteria (1 listed)
- not specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and Ascites ELISPOT | Other | two-step algorithm-based approach |
Primary outcome
the frequency of laparoscopic biopsy
Time frame: 1 week after the enrollment
1 secondary outcome
the frequency of correct or wrong diagnosis
Time frame: 6 months after the enrollment
Results and safety
The study was stopped early (reason given: low enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Han Kim, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and Ascites ELISPOT in people with Suspected Tuberculous Peritonitis, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low enrollment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the frequency of laparoscopic biopsy (time frame: 1 week after the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.