DIAGNOSEDh
Sponsor study identifier
interventional
80
0 countries
N/A
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Thirteen types of EDS have been described based on their clinical manifestations and genetic backgrounds. Their diagnosis relies on personal and family medical history, together with established clinical criteria. A definitive diagnosis can then be confirmed through genetic testing. However, definitive diagnosis of hypermobile Ehlers-Danlos syndrome (hEDS), the most common EDS subtype (\>80% of cases), remains impossible because its molecular basis is still unknown. The diagnosis of hEDS is based on a set of clinical criteria, some of which are subject to examiner interpretation. These criteria have limitations at the extremes of age and in mild or incomplete forms, potentially preventing a formal diagnosis. Patients may consequently experience a diagnostic odyssey and psychological distress, without recognition of their condition or access to appropriate management. The diagnosis of hEDS is further complicated by the overlap between its clinical manifestations and those of Hypermobility Spectrum Disorders (HSD), which are relatively common in the general population (1-3%). HSD are also characterized by joint hypermobility, which may be complicated by joint instability and pain, but unlike hEDS, they are not associated with tissue fragility. There is therefore an urgent need to identify a reliable, simple, reproducible, and widely accessible diagnostic criterion to establish a diagnosis of hEDS in the large population of hypermobile patients. Tenascin-X (TN-X) is a glycoprotein involved in the assembly of the ECM. One study showed that TN-X levels were reduced by 35% in 52% of hypermobile patients (9/17) compared with healthy controls. This finding suggests a possible association between serum TN-X levels and hEDS. However, no correlation has yet been investigated. We hypothesize that serum TN-X levels could serve as a biological diagnostic criterion for hEDS.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 30, 2026
Actual (reported)October 27, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Measurement of TN-X concentration
Measurement of TN-X concentration (ng/mL) in serum from the experimental population (= patients with hypermobile Ehlers-Danlos syndrome \[hEDS\]) and the control population (= healthy volunteers), using a targeted quantitative proteomics approach based on mass spectrometry We will assess the ability of the serum TN-X level to discriminate between patients with and without hEDS, classified according to the gold standard, using the area under the ROC curve, estimated as a point estimate and with a 95% confidence interval. The diagnosis of hEDS, considered the gold standard, will be established according to the clinical criteria validated by the International Consortium on Ehlers-Danlos Syndromes \[4,5\], by a physician with expertise in this rare disease at the participating centers.
through study completion, an average of 1 year
Diagnostic threshold for serum TN-X levels for the diagnosis of hEDS
through study completion, an average of 1 year
Collection of blood samples (serum and whole blood) during a follow-up visit as part of the participant's usual care for TN-X concentration measurement
Collection of blood samples (serum and whole blood) for TN-X concentration measurement
Collection of blood samples (serum and whole blood) for TN-X concentration measurement
Karelle Benistan, MD
Assistance Publique - Hôpitaux de Paris
First Submitted
September 30, 2026
First Posted
October 27, 2026
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 1, 2027
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-09
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