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Registry for Vascular Anomalies Associated With Coagulopathy (VAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Medical College of Wisconsin
Sponsor:
Information provided by (Responsible Party):
Beth Drolet, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00576888
First received: December 18, 2007
Last updated: November 14, 2014
Last verified: November 2014

December 18, 2007
November 14, 2014
November 2007
December 2015   (final data collection date for primary outcome measure)
Number of patients with genetic mutations, copy number variations and/or expression analysis [ Time Frame: After DNA collected and batches are sent for analysis ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00576888 on ClinicalTrials.gov Archive Site
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Registry for Vascular Anomalies Associated With Coagulopathy
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

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.

Observational
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Retention:   Samples With DNA
Description:

Buccal swab, tissue biopsy if available

Non-Probability Sample

All patients diagnosed with Multifocal lymphangioendotheliomatosis with thrombocytopenia (MLT) or with a vascular anomaly with coagulopathy

  • Multifocal Lymphangioendotheliomatosis With Thrombocytopenia
  • Cutaneovisceral Angiomatosis With Thrombocytopenia
  • Vascular Anomaly With Thrombocytopenia
  • Hemangiomas
Other: no intervention
no intervention - observational only
Vascular Anomaly with Coagulopathy
All patients diagnosed with Multifocal lymphangioendotheliomatosis with thrombocytopenia (MLT) or with a vascular anomaly with coagulopathy
Intervention: Other: no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with a vascular anomaly with coagulopathy

Exclusion Criteria:

  • Subjects without a vascular anomaly with coagulopathy
Both
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No
Contact: Beth A Drolet, MD (414) 955-2819 bdrolet@mcw.edu
United States
 
NCT00576888
CHW07/226, GC567
No
Beth Drolet, Medical College of Wisconsin
Medical College of Wisconsin
Not Provided
Principal Investigator: Beth Drolet, MD Medical College of Wisconsin
Principal Investigator: Ulrich Broeckel, MD Medical College of Wisconsin
Principal Investigator: Howard Jacob, PhD Medical College of Wisconsin
Principal Investigator: Michael Kelly, MD, 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
Medical College of Wisconsin
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP