- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00576888
Registry for Vascular Anomalies Associated With Coagulopathy (VAC)
September 12, 2019 updated by: Beth A Drolet, MD, Medical College of Wisconsin
International Registry for Vascular Anomalies Associated With Coagulopathy
PURPOSE The purpose of this study is to learn more about multifocal lymphangioendotheliomatosis with thrombocytopenia (MLT).
MLT is a rare vascular disorder characterized by multiple congenital skin and visceral lesions, profound thrombocytopenia, and gastrointestinal bleeding.
The skin lesions may appear red, brown or blue, often misdiagnosed as hemangiomas.
The gastrointestinal tract, liver, and lungs are the most common internal organs involved.
The severe thrombocytopenia (low platelets) is believed to be the result of platelet trapping within the skin and visceral vascular lesions.
Severe and chronic gastrointestinal bleeding is common during infancy and early childhood.
Although a relatively newly described entity, MLT was likely previously reported as hemangiomas, blue rubber bleb nevus syndrome, diffuse hemangiomatosis, Kasabach-Merritt phenomenon, and hereditary hemorrhagic telangiectasia.
The term cutaneovisceral angiomatosis with thrombocytopenia is also a term used for this same disease.
This study is a longitudinal cohort study of MLT to collect detailed clinical data on the distribution of disease, disease severity, and complications.
This data will be used to create diagnostic criteria and an evaluation protocol for infants with this disease
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
After informed consent is obtained a detailed question will be mailed to participating patients and families.
This questionnaire will also be available electronically through an educational website.
Data collected will include photographs of skin lesions, video images of gastrointestinal lesions, demographic data, clinical information, therapeutic interventions, glass slides of tissue biopsies, and collection of DNA.
Enrollment will be patient family driven and modeled after several successful registries of rare diseases.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Medical College Of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients diagnosed with Multifocal lymphangioendotheliomatosis with thrombocytopenia (MLT) or with a vascular anomaly with coagulopathy
Description
Inclusion Criteria:
- Subjects with a vascular anomaly with coagulopathy
Exclusion Criteria:
- Subjects without a vascular anomaly with coagulopathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Vascular Anomaly with Coagulopathy
All patients diagnosed with Multifocal lymphangioendotheliomatosis with thrombocytopenia (MLT) or with a vascular anomaly with coagulopathy
|
no intervention - observational only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with genetic mutations, copy number variations and/or expression analysis
Time Frame: After DNA collected and batches are sent for analysis
|
Expand knowledge on consensus diagnostic criteria, atypical presentations and long term outcomes of patients with vascular anomalies
|
After DNA collected and batches are sent for analysis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Kelly, MD, PhD, Medical College Of Wisconsin
- Principal Investigator: Ulrich Broeckel, MD, Medical College Of Wisconsin
- Principal Investigator: Howard Jacob, PhD, Medical College Of Wisconsin
- Principal Investigator: Richard Noel, MD, PhD, Medical College Of Wisconsin
- Principal Investigator: Paula North, MD, PhD, Medical College Of Wisconsin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
April 5, 2019
Study Registration Dates
First Submitted
December 18, 2007
First Submitted That Met QC Criteria
December 18, 2007
First Posted (Estimate)
December 19, 2007
Study Record Updates
Last Update Posted (Actual)
September 16, 2019
Last Update Submitted That Met QC Criteria
September 12, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHW07/226
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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