An observational study in Tuberculosis and Diagnoses Disease, sponsored by Ospedale San Raffaele. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Ospedale San Raffaele · Observational
Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU).
STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay which detects lipoarabinomannan in human urine sample. The test evaluated in this study may provide benefits for the development of non sputum-based, less invasive tuberculosis diagnostics that include easier to collect biological samples. The study can therefore be relevant for updating WHO guidelines for TB diagnosis. The results of the STANDARDTM F TB LAM Ag FIA will be interpreted according to the manufacturer´s instructions and will be compared to the results of the test performed to confirm the pulmonary TB, the extrapulmonary TB or the pulmonary NTM diagnosis (intention to treat assay). The test will be repeted at the end of the anti-TB therapy to evaluate if the test can be used as marker of treatment response. Healthy subjects without exposure or risk for TB factors will serve as a proxy for specificity; subjects with confirmed TB will serve as control group to estimate sensitivity.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 550 is above the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →Ospedale San Raffaele is the lead sponsor of 46 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects attending the Infectious Diseases Ward of the participating centers with a pulmonary TB, pulmonary NTM or extrapulmonary TB. Healthy controls,
Inclusion Criteria:
Inclusion criteria for PTB, PNTM and extraPTB:
Inclusion criteria for HC:
Exclusion Criteria:
Exclusion criteria for PTB, PNTM and extraPTB:
Exclusion criteria for HC:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with a pulmonary TB
Device: STANDARDTM F TB LAM FIA
Subjects with pulmonary NTM
Device: STANDARDTM F TB LAM FIA
Subjects with extrapulmonary TB
Device: STANDARDTM F TB LAM FIA
Healthy controls donors
Device: STANDARDTM F TB LAM FIA
STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay for the qualitative detection of specific antigen from mycobacterial lipoarabinomannan (LAM) in urine specimen. STANDARDTM F TB LAM Ag FIA should be used with the STANDARD F Analyzers manufactured by SD BIOSENSOR.
Evaluate the diagnostic performance of a new test based on the detection of lipoarabinomannan (LAM) antigen in human urine using immunoassay
STANDARDTM F TB LAM Ag FIA is a fluorescent immunoassay for the qualitative detection of specific antigen from mycobacterial lipoarabinomannan (LAM) in urine. The test should be used with the STANDARD F Analyzers manufactured by SD BIOSENSOR that are Europium (Eu) based fluorescent immunoassay system and have been designed for easy and reliable measuring of diverse parameters. The test result of a specimen is given either as Positive or Negative with a COI (cut off index) value. The test may provide benefits for the development of non sputum-based, less invasive tuberculosis diagnostics that include easier-collect biological samples. The results of the test will be compared to the results of the test performed to confirm the pulmonary TB, the extrapulmonary TB or the pulmonary NTM diagnosis Healthy subjects without exposure or risk for TB factors will serve as a proxy for specificity; subjects with confirmed TB will serve as control group to estimate sensitivity.
Time frame: 12 months
Exploratory Objectives Evaluate if the test can be used as marker of treatment response (only for PTB subjects)
The test will be repeated at the end of the anti-TB therapy to evaluate if the test can be used as marker of treatment response.We want to evaluate whether, in the face of therapeutic success, the test becomes negative (reversion of results).
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Oct 2024, 0 months later.
Of 122 non-industry observational studies under Tuberculosis, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 0 months is below that.
Counting every sponsor, half of 134 studies reached it within 36 months; a quarter within 21 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Ospedale San Raffaele