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OpenTrials
Completed

NCT Number: NCT02574676

Quality of Life (QOL) Registry for Patients With AL Amyloidosis

This is an online registry to document the psychometric properties of SF-36v2 among patients with AL Amyloidosis, to document patients' burden of disease, to better understand the patient's experience and to follow quality of life issues using a variety of QOL measures.

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Key information

Conditions

AL Amyloidosis Amyloidosis Immune System Diseases Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Lymphoproliferative Disorders Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nutritional and Metabolic Diseases Paraproteinemias Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Online registry

South San Francisco, California, 94080, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must have AL Amyloidosis

Exclusion criteria

Treatment and study plan

Non-Interventional

Other

Primary outcomes

  1. Psychometric evaluation of short-form 36 (SF-36v2) in patients with AL Amyloidosis

    Time frame: Change from Baseline to 12 months

Secondary outcomes

  1. Calculate burden of illness from participants using SF-36 Mental Component Score (MCS) and Physical Component Score (PCS) compared with sample from US general population and three other chronic conditions: Congestive Heart Failure, Lymphoma and COPD

    Time frame: Baseline- cross sectional

    The comparison is made to other populations from the baseline cross-sectional measurements. There is no timeframe, except baseline

  2. Assess the pathway to diagnosis and treatment through a disease history specific questionnaire collecting organ involvement, initial symptoms, diagnosis duration, treatment received and other disease characteristics

    Time frame: Baseline- cross sectional

    The analysis is done atbaseline .

  3. Psychometric evaluation of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) in patients with AL Amyloidosis

    Time frame: Change from Baseline to 12 months

  4. Psychometric evaluation of Patient Global Impression-Severity Scale (PGI-S) in patients with AL Amyloidosis

    Time frame: Change from Baseline to 12 months

  5. Psychometric evaluation of Patient Global Assessment of Functioning (GAF) Scale in patients with AL Amyloidosis

    Time frame: Change from Baseline to 12 months

  6. Psychometric evaluation of Hematology Patient Reported Symptom Screen (HPRSS) in patients with AL Amyloidosis

    Time frame: Change from Baseline to 12 months

  7. Psychometric evaluation of Work Productivity and Activity Questionnaire: Specific Health Problem V2.0 (WPAI:SHP) in patients with AL Amyloidosis

    Time frame: Change from Baseline to 12 months

  8. Psychometric evaluation of MOS 6-Item Sleep Scale Standard in patients with AL Amyloidosis

    Time frame: Change from Baseline to 12 months

Sponsors and collaborators

Lead sponsor

Prothena Biosciences Ltd.

Industry

Collaborators

  • Amyloidosis Foundation
  • Amyloidosis Research Consortium
  • Amyloidosis Support Groups
  • Quality Metrics

Registry information

Official study title

Prospective Observational Study Measuring the Short-Form36 ( SF-36v2) and Other QOL Tools in an AL Amyloidosis Population

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 14, 2015
Registry last updated
Apr 9, 2019

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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