Patient-Reported Outcome Questionnaire for Systemic Masto... | NCT02380222

Studies
Patient-Reported Outcome Questionnaire for Systemic Mastocytosis

NCT02380222

Sponsor

Adelphi Values LLC

Status

Completed

Last Update Posted

Jan 10, 2017Estimated

Enrollment

5Actual

Phase

Not provided

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

Interventions

Interview

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Feb 26, 2015

First Submission Date that Met QC Criteria

Mar 2, 2015

First Posted Date

Mar 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2017

Last Update Posted Date

Jan 10, 2017Estimated

Name	Class
Blueprint Medicines Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASM			Other: Interview
SM-AHNMD			Other: Interview
MCL			Other: Interview
SSM			Other: Interview
ISM			Other: Interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interview	Other	Single interview lasting approximately one hour	ASM ISM MCL SM-AHNMD SSM

Measure	Description	Time Frame
Collection of qualitative interview data on the symptoms of advanced systemic mastocytosis		Once

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Adelphi Values LLC		Boston	Massachusetts	02210	United States

ID	Term
D034721	Mastocytosis, Systemic
D007946	Leukemia, Mast-Cell

Ancestor Terms

ID	Term
D008415	Mastocytosis
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D000090362	Mast Cell Activation Disorders
D007154	Immune System Diseases
D007938	Leukemia
D015470	Leukemia, Myeloid, Acute
D007951	Leukemia, Myeloid
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care
D017530	Health Care Quality, Access, and Evaluation
D011634	Public Health
D004778	Environment and Public Health