Patient-Reported Outcome Questionnaire for Systemic Mastocytosis

NCT ID: NCT02380222

Last Updated: 2017-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to explore the key symptoms of individuals with systemic mastocytosis. Interviews of enrolled individuals will be conducted to learn about the disease symptoms and condition. The interview will last approximately 60 minutes and will be conducted by a trained interviewer, be audio-recorded (with patient consent), and all information provided by the patient will be treated confidentially and made anonymous so that it is non-identifiable. The interview may be conducted face-to-face, over the phone, or virtually via Skype, a free video conferencing program, depending upon the patient's geographic location. Patients will be compensated for their participating time.

This is not a medication-related study, and no medication will be distributed or tested during this study. Participation in this study will not affect any treatment or assistance that a patient currently receives or may receive in the future.

Detailed Description

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Conditions

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Aggressive Systemic Mastocytosis (ASM) SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) Mast Cell Leukemia (MCL) Smoldering Systemic Mastocytosis (SSM) Indolent Systemic Mastocytosis (ISM) ISM Subgroup Fully Recruited

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ASM

Interview

Intervention Type OTHER

Single interview lasting approximately one hour

SM-AHNMD

Interview

Intervention Type OTHER

Single interview lasting approximately one hour

MCL

Interview

Intervention Type OTHER

Single interview lasting approximately one hour

SSM

Interview

Intervention Type OTHER

Single interview lasting approximately one hour

ISM

Interview

Intervention Type OTHER

Single interview lasting approximately one hour

Interventions

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Interview

Single interview lasting approximately one hour

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Documented diagnosis of one of the following conditions based upon World Health Organization (WHO) diagnostic criteria: aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated clonal hematologic non-mast cell lineage disease (SM-AHNMD), mast cell leukemia (MCL), smoldering systemic mastocytosis (SSM), indolent systemic mastocytosis (ISM)
* Diagnosis confirmed by bone marrow biopsy
* Fluency in English
* Willingness and ability to participate in a one-hour interview

Exclusion Criteria

* A condition or situation that would interfere with participation in an interview (e.g., cognitive impairment or disorder, alcohol or drug abuse)
* Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness
* Any other prior malignancy except for the following: Adequately treated basal cell or squamous cell skin cancer; In situ cervical cancer; Adequately treated Stage I or II cancer from which the subject is currently in complete remission, or other cancer from which the subject has been disease-free for 2 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Blueprint Medicines Corporation

INDUSTRY

Sponsor Role collaborator

Adelphi Values LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Adelphi Values LLC

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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BL7064A

Identifier Type: -

Identifier Source: org_study_id

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