Wild-type Transthyretin AmyloidosisNCT03966105
Prevalence of Wild Type ATTR
An observational study of Wild-type Transthyretin Amyloidosis, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
Trial summary
Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with lumbar spinal stenosis (LSS). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wild-type Transthyretin Amyloidosis
- What is being tested?
- HE and Congo red staining
- How many people
- 94 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2019to 31 Oct 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective population of 100 patients undergoing LSS surgery.
Who may be able to join
- Male and female ≥ 50 years-old with indication of surgery treatment according to local standards for Lumbar spinal stenosis (LSS) confirmed by MRI
- Availability of the baseline and follow-up annotations
- Informed consent will be obtained from the patient before any study related procedures
Who cannot join
- Previous diagnosis of amyloidosis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Oncology Institute of Southern Switzerland
Bellinzona, Canton Ticino, 6500
About this study
Official title: Prevalence of Amyloidosis in Patients With Lumbar Spinal Stenosis
Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with lumbar spinal stenosis (LSS).
Read the detailed description
The study will include patients that receive surgical management and treatment for LSS, and will consist in the prospective, longitudinal collection of peripheral blood, urine samples, tissue biopsies and clinical data. The results of the project could provide a future benefit for patients with the same condition by: i) identifying accessible and sensitive biomarkers for the identification of patients at risk for having an underlying ATTRwt; ii) optimizing the therapeutic strategies in an era of innovative but cost-intensive treatments; iii) provide the proof of principle for a regular follow-up of patients who eventually will become symptomatic for overt organ ATTRwt involvement; and iv) providing the rationale for future studies based on early access disease-modifying approaches.
- Conditions
- Wild-type Transthyretin Amyloidosis
- Being tested
- HE and Congo red staining
- Keywords
- wild-type TTR amyloidosis, lumbar spinal stenosis, prevalence
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HE and Congo red stainingDiagnostic test
Biopsies will be formalin fixed, processed routinely, and sent to the Department of Pathology for evaluation by hematoxylin and eosin and Congo red staining by pathologists. Biopsy specimens with confirmed amyloid deposits via Congo red staining will be further analyzed using immunohistochemistry for subtyping.
| Study group | Role | What they receive |
|---|---|---|
| Patients with LSS surgery indication | Not described Receives: Diagnostic Test: HE and Congo red staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Report the prevalence of ATTRwt in patients with CTS and/or LSS.
Prevalence of ATTRwt in a prospective population.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Nov 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wild-type Transthyretin 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Southern Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kiel, Ente Ospedaliero Cantonale, Bellinzona
- Responsible party
- Principal investigator, Adalgisa Condoluci, Oncology Institute of Southern Switzerland
- Investigators
- Adalgisa Condoluci, MD, Principal investigator, Oncology Institute of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966105
- Sponsor's protocol ID
- IOSI-EMA-007
- Status last verified
- Mar 2023
- First submitted
- 24 May 2019
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Amyloidosis in Patients With Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT03966105
- Acronym / sponsor ID
- IOSI-EMA-007
- Conditions
- Wild-type Transthyretin Amyloidosis
- Keywords
- wild-type TTR amyloidosis, lumbar spinal stenosis, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Oncology Institute of Southern SwitzerlandUniversity, hospital or other
- Collaborators
- University of Kiel, Ente Ospedaliero Cantonale, Bellinzona
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 29 May 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.
Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with lumbar spinal stenosis (LSS).
Detailed description
The study will include patients that receive surgical management and treatment for LSS, and will consist in the prospective, longitudinal collection of peripheral blood, urine samples, tissue biopsies and clinical data. The results of the project could provide a future benefit for patients with the same condition by: i) identifying accessible and sensitive biomarkers for the identification of patients at risk for having an underlying ATTRwt; ii) optimizing the therapeutic strategies in an era of innovative but cost-intensive treatments; iii) provide the proof of principle for a regular follow-up of patients who eventually will become symptomatic for overt organ ATTRwt involvement; and iv) providing the rationale for future studies based on early access disease-modifying approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with LSS surgery indication | – | Diagnostic Test: HE and Congo red staining |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective population of 100 patients undergoing LSS surgery.
Key inclusion criteria (3 listed)
- Male and female ≥ 50 years-old with indication of surgery treatment according to local standards for Lumbar spinal stenosis (LSS) confirmed by MRI
- Availability of the baseline and follow-up annotations
- Informed consent will be obtained from the patient before any study related procedures
Key exclusion criteria (1 listed)
- Previous diagnosis of amyloidosis
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 |
|---|---|---|
| HE and Congo red stainingBiopsies will be formalin fixed, processed routinely, and sent to the Department of Pathology for evaluation by hematoxylin and eosin and Congo red staining by pathologists. Biopsy specimens with confirmed amyloid deposits via Congo red staining will be further analyzed using immunohistochemistry for subtyping. | Diagnostic test | Patients with LSS surgery indication |
Primary outcome
Report the prevalence of ATTRwt in patients with CTS and/or LSS.
Time frame: 2 years
Prevalence of ATTRwt in a prospective population.
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 27 Mar 2023.
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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.
Adalgisa Condoluci, MD principal investigator
Oncology Institute of Southern Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wild-type Transthyretin Amyloidosis, run by Oncology Institute of Southern Switzerland at 1 site in Switzerland.
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 3 inclusion and 1 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 27 Mar 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 Switzerland. 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?
Report the prevalence of ATTRwt in patients with CTS and/or LSS. (time frame: 2 years). 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 27 Mar 2023.