Urine Sample Collection From FOP Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02066324

Acronym

FOP

Enrollment

Registered

2014-02-19

Start date

2013-11-30

Completion date

2014-08-31

Last updated

2015-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrodysplasia Ossificans Progressiva

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

5 Years to 35 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Diagnosis of diabetes * Diagnosis of other systemic inflammatory disorder (juvenile idiopathic arthritis, systemic lupus erythematosus, etc.) * Diagnosis of cancer other than nonmelanomatous skin cancer.

Design outcomes

Primary

Measure	Time frame	Description
Analysis of pre-defined biomarker FGF2	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	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	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

Countries

United States

Outcome results