NCT02380222

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

February 26, 2015

Last Update Submit

January 6, 2017

Conditions

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

Keywords

Systemic mastocytosisPatient-reported outcome (PRO)

Outcome Measures

Primary Outcomes (1)

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

    Once

Study Arms (5)

ASM

Other: Interview

SM-AHNMD

Other: Interview

MCL

Other: Interview

SSM

Other: Interview

ISM

Other: Interview

Interventions

InterviewOTHER

Single interview lasting approximately one hour

ASMISMMCLSM-AHNMDSSM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of the United States with advanced systemic mastocytosis who volunteer to participate in the study

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adelphi Values LLC

Boston, Massachusetts, 02210, United States

Location

MeSH Terms

Conditions

Mastocytosis, SystemicLeukemia, Mast-Cell

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

MastocytosisNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsMast Cell Activation DisordersImmune System DiseasesLeukemiaLeukemia, Myeloid, AcuteLeukemia, MyeloidHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 5, 2015

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 10, 2017

Record last verified: 2017-01

Locations

US(1)