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Trial record 1 of 1 for:    NCT02066324
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Urine Sample Collection From FOP Patients (FOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02066324
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : March 12, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date February 5, 2014
First Posted Date February 19, 2014
Last Update Posted Date March 12, 2015
Study Start Date November 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 24, 2014)
  • 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 Measures
 (submitted: February 14, 2014)
Analysis of pre-defined biomarkers such as FGF2, WEGF and 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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Urine Sample Collection From FOP Patients
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 Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine samples
Sampling Method Probability Sample
Study Population Patients with Fibrodysplasia Ossificans Progressiva.
Condition Fibrodysplasia Ossificans Progressiva
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 11, 2015)
25
Original Estimated Enrollment
 (submitted: February 14, 2014)
20
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02066324
Other Study ID Numbers CPJMR0062203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor Novartis Pharmaceuticals
Collaborators Not Provided
Investigators Not Provided
PRS Account Novartis
Verification Date March 2015