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Screening for the Transthyretin-Related Familial Amyloidotic Small Fiber Polyneuropathy (TRAP2.1) (TRAP2-1)

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ClinicalTrials.gov Identifier: NCT01705626
Recruitment Status : Recruiting
First Posted : October 12, 2012
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Centogene AG Rostock

Brief Summary:
The goal of this study is to investigate the prevalence of Transthyretin-Related Familial Amyloidotic Polyneuropathy (TTR-FAP) in a cohort of 500 subjects at risk for TTR-FAP, based on the subject's clinical presentation.

Condition or disease
Transthyretin Amyloidosis Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy Polyneuropathies

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TTR-FAP Screening - Screening for the Transthyretin-Related Familial Amyloidotic Small Fiber Polyneuropathy - a International, Multicentre, Epidemiological Protocol
Study Start Date : December 2016
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : April 30, 2020


Group/Cohort
Observation
All adult patients older than 18 years with small fiber polyneuropathy of undetermined etiology.



Biospecimen Retention:   Samples With DNA
For the molecular genetic diagnosis of the disease TTR-FAP a sequencing of the entire TTR gene in all study patients will be performed. Dried blood spots will be used for this procedure.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with small fiber polyneuropathy of undetermined etiology.
Criteria

Inclusion Criteria:

  • Informed consent is obtained from the participant
  • The participant is aged between 18 and 85 years of age
  • The participant is diagnosed with small fiber polyneuropathy of no obvious etiology
  • The participant has no diagnosis of alcoholism, according to International Guidelines
  • The participant has not undergone chemotherapy for carcinoma

Exclusion Criteria:

  • Inability to provide informed consent
  • The participant is younger than 18 years or older than 85 years of age
  • The etiology of the small fiber polyneuropathy is clearly determined
  • The participant has a diagnosis of alcoholism, according to International Guidelines
  • The participant has undergone chemotherapy for carcinoma

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): NCT01705626


Contacts
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Contact: Volha Skrahina, Dr +4938180113594 ext 594 volha.skrahina@centogene.com

Locations
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Austria
Klinikum Wels Recruiting
Wels, Austria, 4600
Contact: Topakian, Prof         
Hungary
Pecs Medical University Recruiting
Pécs, Hungary, 7624
Contact: Pal, Prof         
Szeged Medical University Recruiting
Szeged, Hungary, 6725
Contact: Vescei, Prof         
Poland
Jagiellonian University Medical College Recruiting
Kraków, Poland
Contact: Tomasz Dziedzic, Dr.         
Serbia
KBC Zvezdara Recruiting
Belgrade, Serbia, 11050
Contact: Kostic, MD         
Clinical Center of Serbia Recruiting
Belgrad, Serbia, 11000
Contact: Stevic, Prof         
Center for Polyneuropathies Clinic of Neurology Recruiting
Belgrad, Serbia
Contact: Zorica Stevic, Prof.         
Klinicko Bolnicki Centar Zvezdara Recruiting
Belgrad, Serbia
Contact: Svetlana Kostic-Dedic, Dr.         
Hospital Zrejanin Recruiting
Zrenjanin, Serbia, 23000
Contact: Damjan, MD         
Spain
Hospital de San Sebastian Recruiting
San Sebastián, Spain, 20700
Contact: Poza Aldea, MD         
Sponsors and Collaborators
Centogene AG Rostock
Investigators
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Principal Investigator: Arndt Rolfs, MD Centogene AG Rostock

Additional Information:
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Responsible Party: Centogene AG Rostock
ClinicalTrials.gov Identifier: NCT01705626     History of Changes
Other Study ID Numbers: TRAP 08-2012
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Centogene AG Rostock:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Additional relevant MeSH terms:
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Polyneuropathies
Amyloid Neuropathies
Amyloid Neuropathies, Familial
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Amyloidosis, Familial
Metabolism, Inborn Errors