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Can DiaGO reliably and sensitively detect Graves' orbitopathy?

Can the DiaGO (Diagnosis of Graves’ orbitopathy) clinical assessment tool reliably and sensitively detect people with and without Graves’ orbitopathy? A multicentre study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14189908
Enrollment
400
Registered
2017-12-13
Start date
2016-07-21
Completion date
Unknown
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Metabolic and endocrine disorders, Primary sub-specialty: Metabolic and endocrine disorders

Interventions

This will be a multicentre study across 6 UK centres (Newcastle upon Tyne, Gateshead, Exeter, Cardiff, Oxford and Leeds). Phase 1: Refinement of DiaGO and reproducibility: This phase includes an in

Sponsors

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of GD 2. Hyperthyroidism/subclinical hyperthyroidism and smooth, symmetrical goitre or positive TSH receptor antibodies 3. Euthyroid/hypothyroid/hyperthyroid and positive TSH receptor antibodies

Exclusion criteria

Exclusion criteria: 1. People with Graves' Disease already reviewed by ophthalmology 2. Remain under the care of ophthalmology with GO 3. Children under 18 years of age

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of DiaGO using initial DiaGO data (at baseline, assessment in Endocrine clinic) and diagnosis of GO at six months (after assessment in ophthalmology clinic).

Secondary

MeasureTime frame
Ease of use of DiaGO by endocrinologists and its acceptability at baseline by a user questionnaire Whether use of DiaGO results in earlier employment of treatments to manage GO by clinical records review at six months.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026