NCT02888938

Brief Summary

The aims of this study are: 1° to assess the value of pelvic radiography and sacro-iliac joint (SIJ) MRI compared to CT scan of SIJ for the diagnosis of structural sacro-iliitis and 2° to quantify structural elementary lesions on MRI and for the first time on CT-scan according to a SPARCC approach in a cohort of patients with a suspicion of spondyloarthritis (ECHOSpA).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 5, 2016

Status Verified

August 1, 2016

Enrollment Period

2.5 years

First QC Date

August 31, 2016

Last Update Submit

August 31, 2016

Conditions

Structural Sacro-iliitis

Outcome Measures

Primary Outcomes (4)

  • Diagnostic value of pelvic radiograph compared to CT-scan of sacro-iliac joint for the diagnosis of structural sacroiliitis

    according to New York criteria; CT-scan considered as the gold standard

    baseline

  • Diagnostic value of MRI of sacro-iliac joint compared to CT-scan of sacro-iliac joint for the diagnosis of structural sacroiliitis

    according to New York criteria; CT-scan considered as the gold standard

    baseline

  • Quantitative assessment of structural lesions of sacro-iliac joints on CT-scan according to SPARCC for structural assessment and adapted for CT-scan

    baseline

  • Quantitative assessment of structural lesions of sacro-iliac joints on MRI according to SPARCC

    baseline

Study Arms (1)

Patients suspected of SpA

Other: pelvic radiographyOther: pelvic MRIOther: pelvic CT-scan

Interventions

pelvic radiographyOTHER
Patients suspected of SpA
pelvic MRIOTHER
Patients suspected of SpA
pelvic CT-scanOTHER
Patients suspected of SpA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

173 patients issues from ECHOSpA cohort with pelvic radiograph, CT-scan and MRI of SIJ.

You may qualify if:

  • Patients with suspected spondyloarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service deRhumatologie - CHRU Brabois

Vandœuvre-lès-Nancy, France

RECRUITING

Study Officials

  • Damien Loeuille, Pr

    Service deRhumatologie - CHRU Brabois

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Damien Loeuille, Pr

CONTACT

d.loeuille@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 5, 2016

Study Start

January 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

September 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)