AmyloidosisIPANCT02338427
Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis
A study testing Immunohistochemistry and Proteomic analysis in people with Amyloidosis, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
Trial summary
Amyloidosis is involved in many rare diseases in relation to the diversity of amyloid proteins involved in the formation of abnormal tissue deposits. There are approximately 30 proteins involved in amylose's constitution. The therapeutic management varies depending on the type of amyloidosis observed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis
- What is being tested?
- Immunohistochemistry and Proteomic analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesFrance
- Study dates
- May 2016to Nov 2018
- 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
- Upper age to 18 years
- Amylose diagnosis establish by tissue sample, after "Rouge Congo" coloration
- All patient with amylose identified by the two laboratory of anatomopathology
- Sample necessary for realized proteomic analysis
- No opposition at the participation of the study
- Patient sign an informed consent for biology collection
Who cannot join
- Tissue sample inadequate for apply immunohistochemistry or proteomic identification
- Patient trust, guardianship, under legal protection measure, deprived of freedom
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Departemental Vendee
La Roche-sur-Yon, 85925
CHU de Nantes
Nantes, 44000
About this study
Official title: Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective
Amyloidosis is involved in many rare diseases in relation to the diversity of amyloid proteins involved in the formation of abnormal tissue deposits. There are approximately 30 proteins involved in amylose's constitution. The therapeutic management varies depending on the type of amyloidosis observed.
The application of conventional techniques immunolabeling of amylose does not allow the comprehensive characterization of amylose forms, due to failures of the technic, the false positivity of some results, or lack of frozen tissue available for typing light chain (lambda, kappa).
Read more
In this study, the main objective is the comparison of two capacity of amylose characterisation: immunohistochemistry and proteomics analysis.
The purpose of this study is to validate the superiority of proteomic analysis by demonstrating the improvement of the precision, the reduction of technical failure, as well as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.
- Conditions
- Amyloidosis
- Being tested
- Immunohistochemistry, Proteomic analysis
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunohistochemistryOther
Proteomic analysisOther
| Study group | Role | What they receive |
|---|---|---|
| proteomic | Experimental | Not described Receives: Other: Immunohistochemistry; Other: Proteomic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification success of amylose by immunohistochemistry and proteomic analysis
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startMay 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé MAISONNEUVE, PH, Study director, Centre Hospitalier Départementel Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338427
- Sponsor's protocol ID
- CHD 063-14
- Acronym
- IPA
- Status last verified
- Dec 2018
- First submitted
- 12 Jan 2015
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capacity of Amylose Characterisation Compare by Immunohistochemistry and Proteomic Analysis. Multicenter Prospective
- ClinicalTrials.gov ID
- NCT02338427
- Acronym / sponsor ID
- IPA / CHD 063-14
- Conditions
- Amyloidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 14 Jan 2015 (estimated)
- 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.
Amyloidosis is involved in many rare diseases in relation to the diversity of amyloid proteins involved in the formation of abnormal tissue deposits. There are approximately 30 proteins involved in amylose's constitution. The therapeutic management varies depending on the type of amyloidosis observed.
The application of conventional techniques immunolabeling of amylose does not allow the comprehensive characterization of amylose forms, due to failures of the technic, the false positivity of some results, or lack of frozen tissue available for typing light chain (lambda, kappa).
In this study, the main objective is the comparison of two capacity of amylose characterisation: immunohistochemistry and proteomics analysis.
The purpose of this study is to validate the superiority of proteomic analysis by demonstrating the improvement of the precision, the reduction of technical failure, as well as the correction of erroneous diagnosis, authorizing a more adapted therapeutic management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| proteomic | Experimental | Other: Immunohistochemistry, Other: Proteomic analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Upper age to 18 years
- Amylose diagnosis establish by tissue sample, after "Rouge Congo" coloration
- All patient with amylose identified by the two laboratory of anatomopathology
- Sample necessary for realized proteomic analysis
- No opposition at the participation of the study
Key exclusion criteria (2 listed)
- Tissue sample inadequate for apply immunohistochemistry or proteomic identification
- Patient trust, guardianship, under legal protection measure, deprived of freedom
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 |
|---|---|---|
| Immunohistochemistry | Other | proteomic |
| Proteomic analysis | Other | proteomic |
Primary outcome
Identification success of amylose by immunohistochemistry and proteomic analysis
Time frame: Inclusion
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 24 Dec 2018.
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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.
Hervé MAISONNEUVE, PH study director
Centre Hospitalier Départementel Vendée
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunohistochemistry and Proteomic analysis in people with Amyloidosis, run by Centre Hospitalier Departemental Vendee at 2 sites 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 2 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 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Identification success of amylose by immunohistochemistry and proteomic analysis (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2018.