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Trial record 65 of 359 for:    transthyretin

Prevalence of Wild Type ATTR

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ClinicalTrials.gov Identifier: NCT03966105
Recruitment Status : Not yet recruiting
First Posted : May 29, 2019
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
University of Kiel
Ente Ospedaliero Cantonale, Bellinzona
Information provided by (Responsible Party):
Adalgisa Condoluci, Oncology Institute of Southern Switzerland

Brief Summary:
Prospective, observational, single-centre, non-interventional study aiming at reporting the prevalence of ATTRwt in patients with carpal tunnel syndrome (CTS) and/or lumbar spinal stenosis (LSS).

Condition or disease Intervention/treatment
Transthyretin Amyloidosis Diagnostic Test: HE and Congo red staining

Detailed Description:
The study will include patients that receive surgical management and treatment for CTS and 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Amyloidosis in Patients With Lumbar Spinal Stenosis or Carpal Tunnel Syndrome
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Group/Cohort Intervention/treatment
Patients with CTS surgery indication Diagnostic Test: HE and Congo red staining
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.

Patients with LSS surgery indication Diagnostic Test: HE and Congo red staining
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.




Primary Outcome Measures :
  1. Report the prevalence of ATTRwt in patients with CTS and/or LSS. [ Time Frame: 2 years ]
    Prevalence of ATTRwt in a prospective population.


Biospecimen Retention:   Samples With DNA
Tissue biopsies


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospective population of 200 patients undergoing CTS surgery and 100 patients undergoing LSS surgery.
Criteria

Inclusion Criteria:

  • Male and female ≥ 50 years-old with indication of surgery treatment according to local standards for Carpal tunnel syndrome (CTS) documented at ENMG evaluation and/or o 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

Exclusion Criteria:

  • Previous diagnosis of amyloidosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03966105


Contacts
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Contact: Adalgisa Condoluci, MD +41(0)918118105 adalgisa.condoluci@eoc.ch
Contact: Bernhard Gerber, PD +41(0)918118186 bernhard.gerber@eoc.ch

Locations
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Switzerland
Oncology Institute of Southern Switzerland Not yet recruiting
Bellinzona, Ticino, Switzerland, 6500
Contact: Adalgisa Condoluci, MD    +41(0)918118105    adalgisa.condoluci@eoc.ch   
Sponsors and Collaborators
Oncology Institute of Southern Switzerland
University of Kiel
Ente Ospedaliero Cantonale, Bellinzona
Investigators
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Principal Investigator: Adalgisa Condoluci, MD Oncology Institute of Southern Switzerland

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Responsible Party: Adalgisa Condoluci, MD, Resident Physician, Oncology Institute of Southern Switzerland
ClinicalTrials.gov Identifier: NCT03966105     History of Changes
Other Study ID Numbers: IOSI-EMA-007
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adalgisa Condoluci, Oncology Institute of Southern Switzerland:
wild-type
carpal tunnel syndrome
lumbar spinal stenosis
prevalence

Additional relevant MeSH terms:
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Amyloidosis
Carpal Tunnel Syndrome
Spinal Stenosis
Amyloid Neuropathies, Familial
Proteostasis Deficiencies
Metabolic Diseases
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Amyloid Neuropathies
Genetic Diseases, Inborn
Amyloidosis, Familial
Metabolism, Inborn Errors