Urine Sample Collection From FOP Patients
FOP
Urine Sample Collection From Patients With Fibrodysplasia Ossificans Progressiva (FOP) for Biomarker Analysis
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 5, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMarch 12, 2015
March 1, 2015
9 months
February 5, 2014
March 11, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Analysis of pre-defined biomarker FGF2
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
3 months
Analysis of pre-defined biomarker WEGF
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
3 months
Analysis of microRNAs
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
3 months
Eligibility Criteria
Patients with Fibrodysplasia Ossificans Progressiva.
You may qualify if:
- Male and female patients ≥ 5 and ≤ 35 years of age with a diagnosis of FOP.
- Physically able to provide first-morning urine sample of at least 30 mL
- Able to communicate well with the investigator, to understand and comply with the requirements of the study
- About half of the patients enrolled should have a flare-up, which is defined as an acute exacerbation of disease activity characterized by two or more of the following symptoms: pain, swelling, decreased range of motion, impaired function
You may not qualify if:
- Diagnosis of diabetes
- Diagnosis of other systemic inflammatory disorder (juvenile idiopathic arthritis, systemic lupus erythematosus, etc.)
- Diagnosis of cancer other than nonmelanomatous skin cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104, United States
Biospecimen
Urine samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2014
First Posted
February 19, 2014
Study Start
November 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
March 12, 2015
Record last verified: 2015-03