Clinical Trial: Urine Sample Collection From FOP Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Urine Sample Collection From Patients With Fibrodysplasia Ossificans Progressiva (FOP) for Biomarker Analysis

Brief Summary: The purpose of this study is to collect urine samples from patients with fibrodysplasia ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease progression and for prediction of flare-ups of the disease. Disease related biomarkers in these patients are currently unknown. This study aims to support the development of novel therapy/ies for this disease.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

• Analysis of pre-defined biomarker FGF2 [ Time Frame: 3 months ]
  The objective of this study is to collect urine samples from patients with FOP over a time period covering ideally quiescent disease status and progression through a flare-up for biomarker analysis
• Analysis of pre-defined biomarker WEGF [ Time Frame: 3 months ]
  The objective of this study is to collect urine samples from patients with FOP over a time period covering ideally quiescent disease status and progression through a flare-up for biomarker analysis
• Analysis of microRNAs [ Time Frame: 3 months ]
  The objective of this study is to collect urine samples from patients with FOP over a time period covering ideally quiescent disease status and progression through a flare-up for biomarker analysis

Original Primary Outcome: Analysis of pre-defined biomarkers such as FGF2, WEGF and microRNAs [ Time Frame: 3 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: February 5, 2014
Date Started: November 2013
Date Completion:
Last Updated: March 11, 2015
Last Verified: March 2015