Partners Calciphylaxis Biobank
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
Calciphylaxis, a vascular calcification disorder, is a rare and serious disorder characterized by calcification of dermal arterioles.
There are significant gaps in the understanding of the pathophysiology and risk factors for calciphylaxis. At present, there is no effective treatment. Uncertain pathobiology, rare incidence and lack of collaborative approach have been some of the major limiting factors towards treating calciphylaxis.
The Partners Calciphylaxis Biorepository (PCB) aims to address these gaps within calciphylaxis research by utilizing existing and, when necessary, developing new infrastructure to support the consent of patients and the collection of dedicated samples for a calciphylaxis repository.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female ≥18 years old
Skin lesions consistent with calciphylaxis diagnosis as determined by the treating clinician
Informed of the investigational nature of the study and sign written Informed consent OR are eligible for surrogate consent process based on impaired decision making
Disqualifiers
Patients <18 years of age
Prisoners
Trial population
Patients with skin lesions consistent with calciphylaxis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: Study participants
Trial outcomes
Primary outcomes
1
Number of patients with improvement in calciphylaxis skin lesions
Skin lesions will be assessed by investigators at baseline (entry into study) and at 6 months to determine whether there is improvement. The investigators will determine clinical, laboratory and genetic predictors of this outcome in calciphylaxis patients.
Time frame
6 monthsSecondary outcomes
1
Number of patients with >30% improvement in pain severity
Pain severity will be assessed by investigators at baseline (entry into study) and at 4 weeks to determine whether there is improvement. Pain is measured using Wong-Baker Faces pain rating scale. The investigators will examine clinical, laboratory and genetic predictors of this outcome in calciphylaxis patients.
Time frame
4weeks2
Time to death in patients with calciphylaxis
Time to death is defined as time from the diagnosis of calciphylaxis to death (or to the end of follow up). The investigators will examine clinical, laboratory and genetic predictors of this outcome in calciphylaxis patients.
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov