NGS Strategy Effectiveness in Molecular Diagnosis

NCT ID: NCT03557567

Last Updated: 2018-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-29

Study Completion Date

2017-09-30

Brief Summary

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The coming out of Next Generation Sequencing (NGS) technologies, with documented advantages and reduced costs respect to Sanger sequencing, has provided new appealing approaches to diagnostic testing. Despite this, its use for routine diagnostic purposes requires certification in terms of reliability, as well as a cost-effectiveness evaluation.

To test the feasibility of using the Ion Torrent Personal Genome Machine (PGM) in clinical diagnosis, we assessed its performance to detect point mutations and big rearrangements previously identified with standard techniques. The diagnostic accuracy and the cost-effectiveness will be evaluated by Health Technology Assessment (HTA) analyses.

Detailed Description

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Conditions

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Multiple Osteochondroma Osteogenesis Imperfecta

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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MO patients

NGS molecular screening

Intervention Type DIAGNOSTIC_TEST

OI patients

NGS molecular screening

Intervention Type DIAGNOSTIC_TEST

Interventions

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NGS molecular screening

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Multiple Osteochondroma
* Clinical diagnosis of Osteogenesis Imperfecta
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role collaborator

Regione Emilia-Romagna

OTHER

Sponsor Role collaborator

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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PRUA1GR-2013-00000177

Identifier Type: -

Identifier Source: org_study_id

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