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AL AmyloidosisNCT02574676

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

An observational study of AL Amyloidosis and Amyloidosis, run by Prothena Biosciences Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AL Amyloidosis, Amyloidosis
What is being tested?
non-interventional
How many people
343 participants
Where
1 siteUnited States
Study dates
Oct 2015to Jul 2018
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with Al Amyloidosis

Who may be able to join

  • Patients must have AL Amyloidosis

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Online registry

    South San Francisco, California, 94080

Other trials in United States

About this study

Official title: 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.

Being tested
non-interventional
Medical subject headings
Immunoglobulin Light-chain Amyloidosis, Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non-interventionalOther

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Change from Baseline to 12 months

Secondary outcomes (8)

  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

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

    Measured: Baseline- cross sectional

  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

    The analysis is done atbaseline .

    Measured: Baseline- cross sectional

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

    Measured: Change from Baseline to 12 months

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

    Measured: Change from Baseline to 12 months

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

    Measured: Change from Baseline to 12 months

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

    Measured: 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

    Measured: Change from Baseline to 12 months

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

    Measured: Change from Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJul 2018
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
343 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02574676
Sponsor's protocol ID
CO-083252
Status last verified
Apr 2019
First submitted
5 Oct 2015
Last updated
9 Apr 2019
Results posted
No
Data monitoring committee
No

Publications

  • Bayliss M, McCausland KL, Guthrie SD, White MK. The burden of amyloid light chain amyloidosis on health-related quality of life. Orphanet J Rare Dis. 2017 Jan 19;12(1):15. doi: 10.1186/s13023-016-0564-2.

    PubMed 28103898

Questions about this trial

What is this clinical trial studying?

An observational study of AL Amyloidosis and Amyloidosis, run by Prothena Biosciences Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychometric evaluation of short-form 36 (SF-36v2) in patients with AL Amyloidosis (time frame: Change from Baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02574676, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.

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