A Study of Capillaries in Nailfolds of Healthy Children and Children with the Diagnosis of Systemic Auto-immune/inflammatory Diseases
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-003557
Sponsor Protocol Number: 18-003557
About this study
The purpose of this study is the evaluation of morphology of capillaries in nailfolds of healthy children and children with the diagnosis of systemic auto-immune/inflammatory diseases.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age: 2.5 years - 18 years
- Healthy controls recruited either from schools, from the environment of the investigator or from siblings of patients seen at the pediatric rheumatology clinic.
- Consecutive patients visiting the pediatric rheumatology clinic with confirmed diagnosis of one of the following systemic autoimmune/inflammatory disease:
- JIA, according to ILAR criteria2.
- Juvenile Systemic Sclerosis (jSSc), according to the new preliminary classification criteria of JSSc3.
- Juvenile localized Sclerosis (jlSc), based upon clinical judgment
- Pediatric onset MCTD, according to Alarcon-Segovia or Kasukawa4, 5.
- Definite diagnosis of childhood-onset systemic lupus erythematosus (cSLE), according to ACR classification criteria or SLICC criteria6, 7.
- Suspected diagnosis of cSLE, fulfilling less than 4 criteria of ACR or SLICC.
- Juvenile dermatomyositis (JDM), according to Bohan and Peter diagnostic criteria8.
- Vasculitis, according to EULAR/PRINTO/PRESS9.
- Auto-inflammatory diseases, based upon clinical judgment.
Exclusion Criteria:
- Subject who gave no consent.
- Patient does not fulfill the proposed criteria at time of entry in the study
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ashima Makol, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available