Performance of Clinical Metagenomics in Stool and Urine Samples for Unexplained Diseases Diagnost… (NCT07603453) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Performance of Clinical Metagenomics in Stool and Urine Samples for Unexplained Diseases Diagnostic and Emerging Diseases Surveillance in Immunocompromised Patients
France120 participantsStarted 2026-06-01
Plain-language summary
The study is based on the hypothesis that the concomitant use of mNGS in non-invasive samples (stool, urine) could improve the rate of detected pathogens in immunodeficient patients compared with mNGS performed in an invasive reference sample alone (blood, CSF, broncho-alveolar lavage fluid (BAL), tissue).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pediatric or adult patient with a primary or secondary immune deficiency (including immunosuppressive therapy, chemotherapy, HIV infection).
* mNGS prescription on tissue, CSF, BAL and/or blood to identify the causative pathogen in patient with symptoms or biological signs compatible with an infection as per investigator's judgment (e.g., fever, leukocytosis, increased CRP level)
* Non opposition of the participant (or parent(s)/ legal guardian(s) of infant participant)
Exclusion Criteria:
* No healthcare insurance
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial uses stool and urine samples as a way to detect infections without more invasive procedures, could this kind of metagenomic testing help identify what's causing my infections when standard tests haven't given a clear answer?
2This study is not yet recruiting — how far away do you think it might be before it opens, and is there anything similar already available that could help with my diagnosis in the meantime?
3Because I'm immunocompromised, I may be vulnerable to unusual or rare pathogens that standard lab tests miss — do you think a broad metagenomic approach like this one could realistically find something my current workup wouldn't?
4This trial is listed as Phase NA, meaning it's focused on evaluating a diagnostic tool rather than testing a treatment — does that change the risk profile for me, and are there any concerns about how my samples would be used or stored?
5If this study does detect a pathogen in my stool or urine samples, would that finding be shared with my care team right away so it could actually guide my treatment, or is the data only used for research purposes?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Detection of a "causative" or "possibly causative" pathogens by mNGS in Non-Invasive (stool and/or urine) and invasive samples (blood, CSF, BAL and/or tissue)