Patient-Reported Outcome Questionnaire for Systemic Mastocytosis

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.

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Key information

Conditions

Aggressive Systemic Mastocytosis (ASM) Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Indolent Systemic Mastocytosis (ISM) ISM Subgroup Fully Recruited Leukemia Leukemia, Mast-Cell Leukemia, Myeloid Leukemia, Myeloid, Acute Mast Cell Activation Disorders Mast Cell Leukemia (MCL) Mastocytosis Mastocytosis, Systemic Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) Smoldering Systemic Mastocytosis (SSM)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Adelphi Values LLC

Boston, Massachusetts, 02210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interview

Other

Single interview lasting approximately one hour

Primary outcomes

Collection of qualitative interview data on the symptoms of advanced systemic mastocytosis

Time frame: Once

Sponsors and collaborators

Lead sponsor

Adelphi Values LLC

Industry

Collaborators

Blueprint Medicines Corporation

Registry information

Official study title

Patient-Reported Outcome Questionnaire Development for Symptoms of Systemic Mastocytosis

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 5, 2015
Registry last updated: Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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