Aetiology of TemporaL Arteritis Study
Maneno muhimu
Kikemikali
Maelezo
Objectives and Study Plan:
Study Purpose:
The purpose of the study is to investigate the underlying immunological processes in GCA and to study the pattern of expression of immune response over time to give us information about how best to monitor GCA.
End Point:
The end point will be the final visit of the final patient.
Milestones:
The project is in 3 phases. In phase 1 (0-2 years) patients will be recruited to fulfil the specified primary and secondary objectives. In phase 2 (0-4 years), these patients will be followed up for a total of 2 years each, or until they are discharged from clinic. In phase 3 (1-5 years), further studies will be defined and tissue and data collected under amended ethics.
Tarehe
| Imethibitishwa Mwisho: | 09/30/2015 |
| Iliyowasilishwa Kwanza: | 10/20/2015 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 10/20/2015 |
| Iliyotumwa Kwanza: | 10/21/2015 |
| Sasisho la Mwisho Liliwasilishwa: | 10/20/2015 |
| Sasisho la Mwisho Lilichapishwa: | 10/21/2015 |
| Tarehe halisi ya kuanza kwa masomo: | 12/31/2015 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 12/31/2017 |
| Tarehe ya Kukamilisha Utafiti: | 12/31/2020 |
Hali au ugonjwa
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| GCA Patients referred with suspected GCA, whose final diagnosis is GCA | |
| Not GCA Patients referred with suspected GCA, whose final diagnosis is another disorder |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Njia ya sampuli | Non-Probability Sample |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: 1. 18 years of age or over 2. A clinical suspicion of a new diagnosis of GCA e.g. patients with a new onset of headache, scalp tenderness, with or without elevated CRP or ESR, jaw or tongue claudication with or without visual loss 3. Participants must be willing to give informed written consent or willing to give permission for a nominated friend or relative to provide written informed assent if they are unable to do so because of physical disabilities e.g. sudden onset of blindness/vision loss which can be caused by GCA (this will be made clear in the ethics approval application) Exclusion Criteria: 1. Previous diagnosis of GCA 2. Long term (>1 month) high dose (>20mg per day at any time) steroids for conditions other than PMR, within three months prior to study entry 3. Inability to give informed consent (either written consent or verbal assent from a relative or carer) |
Matokeo
Hatua za Matokeo ya Msingi
1. Phenotyping of innate lymphoid cells (ILC) in the arterial wall and blood of patients with GCA [24 months]
Hatua za Matokeo ya Sekondari
1. CD70 in GCA [12 months]
2. IL-7 and sIL-7R in GCA [36 months]
3. Vascular Endothelial Growth Factor (VEGF) levels over time [36 months]
4. Pentraxin 3 levels over time [36 months]
5. Archiving of tissue for future studies [60 months+]
