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NCT03678740 · ClinicalTrials.gov registry record

Diagnostic Odyssey Survey 2

A clinical trial, sponsored by University of South Florida.

Completed
Registry status
336
Enrollment target

NCT03678740: Completed study, sponsored by University of South Florida.

NCT03678740 is a clinical trial that has completed, run by University of South Florida. The registered enrollment target is 336 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03678740 has completed, sponsored by University of South Florida.

COMPLETED
Registry status
336 participants
Enrollment target

Study Summary

A previous NAMDC survey study (NAMDC 7414 - Diagnostic Odyssey Survey, referred to hereafter as Odyssey1), provided a benchmark account of the substantial challenges faced by patients in achieving a diagnosis of mitochondrial disease, and of the impact such a diagnosis has on them (Grier et al. 2018).1 This study was conducted from October 2015 through January 2016. We propose a new survey study (Odyssey2) which will provide an update, additional data collection (duration of the diagnostic odyssey), and allow assessment of next-generation DNA sequencing techniques since Odyssey1 concluded. Odyssey2 will retain the strengths (simplicity, brevity, confidentiality, and data quality assurance measures) which made Odyssey1 successful. While Odyssey2 adds some refinements based on experience learned from Odyssey1, the basic questions are changed as little as possible to maximize comparability, and the additions are limited. Odyssey1 consisted of between 16 and 23 questions, depending on skip patterns, and took an estimated 15 minutes to complete. Odyssey2 consists of between 23 and 33 questions, depending on skip patterns and we estimate that it will take approximately 20 minutes to complete. As in Odyssey1, only patients who report, directly or through a guardian, that they have been informed by a doctor that they have a confirmed mitochondrial disorder will be eligible for Odyssey2.

Primary Outcome

The primary outcome measure is to provide an update, perform additional data collection (duration of the diagnostic odyssey), and allow assessment of next-generation DNA sequencing techniques since Odyssey1 concluded.

Interventions

  • OTHER Odyssey 2 Survey

Trial Details

FieldValue
Enrollment Target 336 participants
Start Date 2018-09-27
Est. Completion 2019-08-02
University of South Florida

252 total trials

What the finished NCT03678740 record still lists

NCT03678740 is an observational study that tracks outcomes without assigning an intervention. The registered 336 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Odyssey 2 Survey is the first listed.

NCT03678740 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03678740 about?

NCT03678740 is a clinical study titled "Diagnostic Odyssey Survey 2". A previous NAMDC survey study (NAMDC 7414 - Diagnostic Odyssey Survey, referred to hereafter as Odyssey1), provided a benchmark account of the substantial challenges faced by patients in achieving a diagnosis of mitochondrial disease, and of the impact such a diagnosis has on them (Grier et al. 2018...

What is the current status of trial NCT03678740?

This trial is currently completed. The enrollment target is 336 participants. The study started on 2018-09-27. Estimated completion is 2019-08-02.

What interventions are being tested in trial NCT03678740?

The interventions under investigation include: Odyssey 2 Survey (OTHER).

Who is sponsoring clinical trial NCT03678740?

This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03678740, the US trial registry maintained by the National Library of Medicine. NCT03678740 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.