- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02574676
Quality of Life (QOL) Registry for Patients With AL Amyloidosis
April 7, 2019 updated by: Prothena Biosciences Ltd.
Prospective Observational Study Measuring the Short-Form36 ( SF-36v2) and Other QOL Tools in an AL Amyloidosis Population
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
343
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
South San Francisco, California, United States, 94080
- Online registry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with Al Amyloidosis
Description
Inclusion Criteria:
- Patients must have AL Amyloidosis
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Psychometric evaluation of short-form 36 (SF-36v2) in patients with AL Amyloidosis
Time Frame: Change from Baseline to 12 months
|
Change from Baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline- cross sectional
|
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 .
|
Baseline- cross sectional
|
Psychometric evaluation of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) in patients with AL Amyloidosis
Time Frame: Change from Baseline to 12 months
|
Change from Baseline to 12 months
|
|
Psychometric evaluation of Patient Global Impression-Severity Scale (PGI-S) in patients with AL Amyloidosis
Time Frame: Change from Baseline to 12 months
|
Change from Baseline to 12 months
|
|
Psychometric evaluation of Patient Global Assessment of Functioning (GAF) Scale in patients with AL Amyloidosis
Time Frame: Change from Baseline to 12 months
|
Change from Baseline to 12 months
|
|
Psychometric evaluation of Hematology Patient Reported Symptom Screen (HPRSS) in patients with AL Amyloidosis
Time Frame: Change from Baseline to 12 months
|
Change from Baseline to 12 months
|
|
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
|
Change from Baseline to 12 months
|
|
Psychometric evaluation of MOS 6-Item Sleep Scale Standard in patients with AL Amyloidosis
Time Frame: Change from Baseline to 12 months
|
Change from Baseline to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
October 5, 2015
First Submitted That Met QC Criteria
October 9, 2015
First Posted (Estimate)
October 14, 2015
Study Record Updates
Last Update Posted (Actual)
April 9, 2019
Last Update Submitted That Met QC Criteria
April 7, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CO-083252
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.
Clinical Trials on AL Amyloidosis
-
Nexcella Inc.Not yet recruitingLight Chain (AL) AmyloidosisUnited States
-
Sorrento Therapeutics, Inc.WithdrawnLight Chain (AL) Amyloidosis
-
Peking Union Medical College HospitalRecruitingLight Chain (AL) Amyloidosis | Venetoclax | CCND1 TranslocationChina
-
European Myeloma NetworkJanssen PharmaceuticaActive, not recruitingLight Chain (AL) Amyloidosis, Stage 3BNetherlands, Greece, France, Italy
-
Boston Medical CenterMillennium Pharmaceuticals, Inc.Completed
-
Tufts Medical CenterSanofiWithdrawnAmyloidosis | Light Chain (AL) Amyloidosis
-
Sorrento Therapeutics, Inc.RecruitingLight Chain (AL) AmyloidosisUnited States
-
Weill Medical College of Cornell UniversityJanssen Scientific Affairs, LLCRecruitingAL Amyloidosis | Amyloid | Refractory AL AmyloidosisUnited States
-
IRCCS Policlinico S. MatteoTerminatedCardiac AL AmyloidosisSpain, France, Italy, Germany, Canada, Greece, Turkey, United Kingdom
-
Prothena Biosciences Ltd.RecruitingLight Chain (AL) AmyloidosisUnited States, Korea, Republic of, Australia, Denmark, France, Italy, Spain, Israel, Taiwan, Austria, Canada, Czechia, Germany, Greece, Hungary, Ireland, Japan, Netherlands, Poland, Portugal, Turkey, United Kingdom, Belgium
Clinical Trials on non-interventional
-
Universitätsklinikum Hamburg-EppendorfSandozUnknownPsoriasisDenmark, Spain, Germany, Poland
-
AIDS Malignancy ConsortiumNational Cancer Institute (NCI)RecruitingUse of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMCHIV Infections | Cancer | HPV-Related Malignancy | Anal Cancer | HIV-Associated Malignant Neoplasm | AIDS Related Lymphoma | AIDS-related Kaposi Sarcoma | AIDS-Related MalignancyUnited States
-
Bristol-Myers SquibbWithdrawnNon-valvular Atrial FibrillationUnited States
-
Papworth Hospital NHS Foundation TrustInnovate UK; Cystic Fibrosis Trust; US Cystic Fibrosis FoundationRecruitingCystic FibrosisUnited Kingdom
-
Royal Marsden NHS Foundation TrustRecruiting
-
Regeneron PharmaceuticalsRecruitingHemophilia BUnited States, Germany, United Kingdom, Canada
-
Henri Mondor University HospitalEuropean Society of Intensive Care MedicineRecruitingFournier Gangrene | Necrotizing Soft Tissue Infection | Necrotizing FasciitisFrance
-
Medtronic Cardiac Rhythm and Heart FailureCompleted
-
Respiratory Effectiveness GroupBoehringer IngelheimCompletedChronic Obstructive Pulmonary DiseaseKorea, Republic of, Singapore, Malta, Italy, Slovenia, Spain
-
Eurasian Association of TherapistsCompletedCardiovascular Diseases | Pneumonia | Hypertension | Diabetes | Covid19 | Coronary Heart Disease | Copd | CKD | Overweight and Obesity | SARS-CoV-2 Infection | Cardiac EventRussian Federation