- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02380222
Patient-Reported Outcome Questionnaire for Systemic Mastocytosis
Patient-Reported Outcome Questionnaire Development for Symptoms of 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02210
- Adelphi Values LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ASM
|
Single interview lasting approximately one hour
|
SM-AHNMD
|
Single interview lasting approximately one hour
|
MCL
|
Single interview lasting approximately one hour
|
SSM
|
Single interview lasting approximately one hour
|
ISM
|
Single interview lasting approximately one hour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Collection of qualitative interview data on the symptoms of advanced systemic mastocytosis
Time Frame: Once
|
Once
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BL7064A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Cogent Biosciences, Inc.RecruitingAdvanced Systemic Mastocytosis (AdvSM) | SM With an Associated Hematologic Neoplasm (SM-AHN) | Mast Cell Leukemia (MCL) | Aggressive Systemic Mastocytosis (ASM)United States, Norway, Spain, Australia, Switzerland, Germany, Belgium, Netherlands, Canada, France, United Kingdom, Austria, Italy
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