NCT02823067

Brief Summary

The primary objective of this observational study is to describe the prevalence of pruritus and pemphigoid in nursing home patients. Secondary outcomes are the relationships of demographic factors and medical risk factors with pemphigoid, including dementia and neuropsychiatric symptoms, medication use and Karnofsky score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

June 28, 2016

Last Update Submit

October 12, 2018

Conditions

PemphigoidPruritus

Keywords

PemphigoidBullous pemphigoidPruritusSenile pruritusNeuropsychiatric symptoms

Outcome Measures

Primary Outcomes (6)

  • Presence of pruritus

    Presence and intensity of pruritus will be determined (hetero-)anamnestically with the Bullous Pemphigoid Disease Area Index (BPDAI) VAS score and derivative score for all subjects.

    Day 1

  • Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence on 1M salt-split human skin substrate

    IgG autoantibodies with epidermal side staining of artificial split; positive/negative, staining intensity IgG 1+,2+,3+

    Day 1

  • Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence microscopy on monkey esophagus substrate

    Anti-basement membrane zone IgG autoantibodies; positive/negative, staining intensity IgG 1+,2+,3+

    Day 1

  • Concentration of anti-BP180 NC16A IgG autoantibodies by ELISA

    Anti-BP180 NC16A IgG index; U/mL, cut-off value 9 U/mL

    Day 1

  • Concentration of anti-BP230 IgG autoantibodies by ELISA

    Anti-BP230 IgG index; U/mL, cut-off value 9 U/mL

    Day 1

  • Detection of circulating pemphigoid specific IgG autoantibodies by immunoblot of keratinocyte extract

    Presence/absence of circulating IgG autoantibodies against BP180 (180kDa) or BP230 (230kDa)

    Day 1

Secondary Outcomes (6)

  • Age

    Day 1

  • Sex

    Day 1

  • Comorbidities

    Day 1

  • Karnofsky Performance Scale

    Day 1

  • Medication

    Day 1

  • +1 more secondary outcomes

Study Arms (1)

Nursing home patients

Nursing home patients aged 65 years or above. One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing.

Other: Blood sample

Interventions

Blood sampleOTHER

One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing.

Nursing home patients

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of 126 nursing home patients aged 65 years or above, living in a nursing home of the University Network Care of the Elderly - UMCG.

You may qualify if:

  • Inpatient of a nursing home
  • Age 65 years or above
  • Subject or their official representatives have signed informed consent

You may not qualify if:

  • Age below 65 years
  • Subjects who do not have signed informed consent
  • Receiving treatment with any systemic immunosuppressive agents
  • Terminally ill patients with a life expectancy of less than 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Pemphigoid, BullousPruritus

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Marcel Jonkman, MD PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 6, 2016

Study Start

June 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations

NL(1)