AmyloidosisTYPAMYLNCT03984721
Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing
A study testing Amyloidosis typing using mass spectrometry-based proteomics in people with Amyloidosis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The main objective is to establish that a new technique of amyloidosis typing by Proteomics (based on nanoLC-MS/MS mass spectrometry) allows typing in > 90% of observations in patients whose Amyloidosis is reported to have failed typing (impossible typing, uncertain or inconsistent) with the traditional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis
- What is being tested?
- Amyloidosis typing using mass spectrometry-based proteomics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2019to 8 Sep 2021
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis of Amyloidosis by Red Congo staining and birefringence in polarized light on tissue sampling
- Immunolabeling Amyloidosis typing
- impossible (no frozen sample available)
- or inconclusive (doubtful)
- or inconsistent with clinical, biological, genetic and iconographic data
- Signature of the informed consent form
Who cannot join
- Insufficient tissue material to perform the new technique
- Person placed under judicial protection
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to establish that a new technique of amyloidosis typing by Proteomics (based on nanoLC-MS/MS mass spectrometry) allows typing in > 90% of observations in patients whose Amyloidosis is reported to have failed typing (impossible typing, uncertain or inconsistent) with the traditional anatomopathological approach, and this in a cohort of 40 patients identified consecutively in the Department of pathological anatomy and cytology of the University Hospital of Toulouse and included prospectively.
- Conditions
- Amyloidosis
- Being tested
- Amyloidosis typing using mass spectrometry-based proteomics
- Keywords
- Mass spectrometry based proteomic analysis, NanoLC-MS/MS, Amyloidosis typing
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amyloidosis typing using mass spectrometry-based proteomicsDiagnostic test
Amyloidosis typing using nanoLC-MS/MS method
| Study group | Role | What they receive |
|---|---|---|
| Amylose typing | Experimental | Amyloidosis typing by nanoLC-MS/MS in patients diagnosed with Amyloidosis but unable to be typed Receives: Diagnostic Test: Amyloidosis typing using mass spectrometry-based proteomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amyloidosis typing
Amyloidosis typing rate with the new technique
Measured: Day 0
Secondary outcomes (2)
Time to return the result
Time to return the result with the new technique (time in days)
Measured: Day 0
Concordance
Agreement between the proteomic conclusion and the clinical judgement (binary answer : yes/no)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start25 Jul 2019
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Inclusion of 40 patients identified by the Department of Anatomy and pathological cytology at the University of Toulouse.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Dominique CHAUVEAU, Principal investigator, CHU Rangueil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984721
- Sponsor's protocol ID
- RC31/16/8768
- Acronym
- TYPAMYL
- Status last verified
- Jul 2023
- First submitted
- 5 Jun 2019
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vrana JA, Gamez JD, Madden BJ, Theis JD, Bergen HR 3rd, Dogan A. Classification of amyloidosis by laser microdissection and mass spectrometry-based proteomic analysis in clinical biopsy specimens. Blood. 2009 Dec 3;114(24):4957-9. doi: 10.1182/blood-2009-07-230722. Epub 2009 Oct 1.
PubMed 19797517Theis JD, Dasari S, Vrana JA, Kurtin PJ, Dogan A. Shotgun-proteomics-based clinical testing for diagnosis and classification of amyloidosis. J Mass Spectrom. 2013 Oct;48(10):1067-77. doi: 10.1002/jms.3264.
PubMed 24130009
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing
- ClinicalTrials.gov ID
- NCT03984721
- Acronym / sponsor ID
- TYPAMYL / RC31/16/8768
- Conditions
- Amyloidosis
- Keywords
- Mass spectrometry based proteomic analysis, NanoLC-MS/MS, Amyloidosis typing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to establish that a new technique of amyloidosis typing by Proteomics (based on nanoLC-MS/MS mass spectrometry) allows typing in > 90% of observations in patients whose Amyloidosis is reported to have failed typing (impossible typing, uncertain or inconsistent) with the traditional anatomopathological approach, and this in a cohort of 40 patients identified consecutively in the Department of pathological anatomy and cytology of the University Hospital of Toulouse and included prospectively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Inclusion of 40 patients identified by the Department of Anatomy and pathological cytology at the University of Toulouse.
| Arm | Type | Receives |
|---|---|---|
| Amylose typing | Experimental | Diagnostic Test: Amyloidosis typing using mass spectrometry-based proteomicsAmyloidosis typing by nanoLC-MS/MS in patients diagnosed with Amyloidosis but unable to be typed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Amyloidosis by Red Congo staining and birefringence in polarized light on tissue sampling
- Immunolabeling Amyloidosis typing
- Signature of the informed consent form
Key exclusion criteria (3 listed)
- Insufficient tissue material to perform the new technique
- Person placed under judicial protection
- Pregnant and breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amyloidosis typing using mass spectrometry-based proteomicsAmyloidosis typing using nanoLC-MS/MS method | Diagnostic test | Amylose typing |
Primary outcome
Amyloidosis typing
Time frame: Day 0
Amyloidosis typing rate with the new technique
2 secondary outcomes
Time to return the result
Time frame: Day 0
Concordance
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Background: PubMed 19797517Vrana JA, Gamez JD, Madden BJ, Theis JD, Bergen HR 3rd, Dogan A. Classification of amyloidosis by laser microdissection and mass spectrometry-based proteomic analysis in clinical biopsy specimens. Blood. 2009 Dec 3;114(24):4957-9. doi: 10.1182/blood-2009-07-230722. Epub 2009 Oct 1.
- Background: PubMed 24130009Theis JD, Dasari S, Vrana JA, Kurtin PJ, Dogan A. Shotgun-proteomics-based clinical testing for diagnosis and classification of amyloidosis. J Mass Spectrom. 2013 Oct;48(10):1067-77. doi: 10.1002/jms.3264.
- Individual participant dataSharing planned: No
Related trials for Amyloidosis
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Recruiting
Longitudinal Quantitative Neuromuscular MRI in Neuropathic Patients
Charcot-Marie-Tooth Neuropathy Type 1A, Hereditary Transthyretin Amyloid Neuropathy
Not yet recruitingObservational study
PET/CT Imaging in Carriers of TTR Mutations
ATTR, ATTR Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique CHAUVEAU principal investigator
CHU Rangueil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amyloidosis typing using mass spectrometry-based proteomics in people with Amyloidosis, run by University Hospital, Toulouse at 1 site in France.
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 6 inclusion and 3 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 12 Jul 2023. 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 France. 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?
Amyloidosis typing (time frame: Day 0). 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 NCT03984721, which also lists 2 linked publications.
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 12 Jul 2023.