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Partners Calciphylaxis Biobank (PCB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032835
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : August 24, 2022
Sponsor:
Information provided by (Responsible Party):
Sagar U. Nigwekar, MD, MMSc, Massachusetts General Hospital

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease
Calciphylaxis Calcific Uremic Arteriolopathy End Stage Renal Disease Chronic Kidney Diseases

Detailed Description:

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.

This repository is working in collaboration with the Partners Biobank as they will still be receiving samples from the PCB and storing them and distributing them according to their own procedures.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Partners Calciphylaxis Biobank and Patient Registry
Study Start Date : January 2017
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Study participants
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with improvement in calciphylaxis skin lesions [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Number of patients with >30% improvement in pain severity [ Time Frame: 4weeks ]
    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.

  2. Time to death in patients with calciphylaxis [ Time Frame: Up to 5 years ]
    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.


Biospecimen Retention:   Samples With DNA
Plasma, serum, DNA and tissue samples (e.g. skin)

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with skin lesions consistent with calciphylaxis
Criteria

Inclusion Criteria:

  1. Male or female ≥18 years old
  2. Skin lesions consistent with calciphylaxis diagnosis as determined by the treating clinician
  3. 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

Exclusion Criteria:

  1. Patients <18 years of age
  2. Prisoners
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032835


Contacts
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Contact: Sagar U Nigwekar, MD, MMSc 617-726-7872 snigwekar@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sagar U Nigwekar, MD, MMSc    617-726-7872    snigwekar@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Sagar U Nigwekar, MD, MMSc Massachusetts General Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: Sagar U. Nigwekar, MD, MMSc, Assistant in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03032835    
Other Study ID Numbers: 2016P002690
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sagar U. Nigwekar, MD, MMSc, Massachusetts General Hospital:
Calciphylaxis
Warfarin
Dialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Calciphylaxis
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases