Mast Cell Connect: A Registry for Patients With Mastocytosis

Mastocytosis Clinical Trial

Official title:

Mast Cell Connect: A Registry for Patients With Mastocytosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620254
• Other study ID #: Mastocytosis Registry
• Status: Completed
• Start date: November 2015
• Est. completion date: January 2021

Study information

• Verified date: February 2021
• Source: Blueprint Medicines Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The Mast Cell Connect Registry is a voluntary, observational database that will capture demographic, socioeconomic, and disease information directly from patients with mastocytosis via a secure web-based tool. No experimental intervention is involved.

Description:

Mastocytosis is an extremely rare and heterogeneous spectrum of diseases characterized by the buildup of genetically altered mast cells. Patients experience a wide range of symptoms and in some cases, mast cell buildup can lead to organ dysfunction and failure. Current treatments address disease symptoms and not the underlying cause. To facilitate the development of new therapies for mastocytosis, it is important for the community to support clinical trials and to document the impact of the disease, including disease natural history and the impact on patients, in a systematic way. Mast Cell Connect is a web-based registry that allows mastocytosis patients and caregivers to enter information about the experience of the patient living with mastocytosis directly into an online data collection tool.

The Mast Cell Connect Registry allows mastocytosis patients and caregivers to enter information about the experience of the patient living with mastocytosis directly into a web-based data collection tool. Two forms of data will be collected: responses to surveys administered on the web-based portal, and de-identified data curated from medical reports uploaded by patients or their caregivers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 743
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any patient with a diagnosis of mastocytosis, including systemic mastocytosis and cutaneous mastocytosis and any subtypes of these diseases, who is willing and able to provide written online informed consent

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Mastocytosis

Locations

Country	Name	City	State
United States	Registry participation is worldwide and not limited to this facility	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Blueprint Medicines Corporation	PatientCrossroads

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improve the collective understanding of the natural history of mastocytosis and its impact on patients		Through completion of the study
Other	Assist in the development of mastocytosis therapy by increasing participation in clinical trials and other research studies for patients with mastocytosis		Through completion of the study
Primary	Further the understanding of the epidemiology of mastocytosis and its subtypes		Through completion of the study

External Links

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