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NCT03590639: VALIDate
Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic (VALIDate)
trial in Inflammatory Bowel Diseases in 400 participants. Completed in 16 April 2020.
9 July 2019
Quick facts
| Lead sponsor | Nantes University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 23 April 2018 |
| Primary completion | 9 July 2019 |
| Estimated completion | 16 April 2020 |
| Sites | 3 locations across France |
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
Sponsor
Nantes University Hospital
Who can join
18 and older, any sex, with Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Inflammatory Bowel Diseases (IBD) often affect psychological, family, social and professional dimensions of patients' life, leading to disability which is essential to quantify as part of Patient-Reported Outcomes (PROs) newly included in the therapeutic targets to reach in IBD patients. Up to now, the IBD-Disability Index (IBD-DI) was the only validated tool to assess functional status, but it is not appropriate for use in clinical practice. The IBD Disk was then developed, a shortened and self-administered tool, adapted from the IBD-DI, in order to give immediate representation of patient-reported disability. However, the IBD Disk has not been validated yet in clinical practice. The aims of the VALIDate study is to validate this tool in a large population of French IBD patients and to compare it to the already validated IBD-DI.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Protocol of a multicentric prospective cohort study for the VALIDation of the IBD-disk instrument for assessing disability in inflammatory bowel diseases: the VALIDate study.
Le Berre C, Bourreille A, Flamant M, Bouguen G, et al · · 2020 · cited 2× · PMID 32299390 · DOI 10.1186/s12876-020-01246-7
Verify or expand the search:
- PubMed search for NCT03590639
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Nantes University Hospital trials
Trials by the same sponsor.
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- NCT07467382 — GOAT (Gait Observation of Achilles Tendon) · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03590639 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nantes University Hospital
- Last refreshed: 22 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03590639.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing