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Registry for Vascular Anomalies Associated With Coagulopathy (VAC)

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: NCT00576888
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Beth A Drolet, MD, Medical College of Wisconsin

Tracking Information
First Submitted Date December 18, 2007
First Posted Date December 19, 2007
Last Update Posted Date September 16, 2019
Study Start Date November 2007
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2019)
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
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00576888 on ClinicalTrials.gov Archive Site
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 Registry for Vascular Anomalies Associated With Coagulopathy
Official Title International Registry for Vascular Anomalies Associated With Coagulopathy
Brief Summary 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
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
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Buccal swab, tissue biopsy if available
Sampling Method Non-Probability Sample
Study Population All patients diagnosed with Multifocal lymphangioendotheliomatosis with thrombocytopenia (MLT) or with a vascular anomaly with coagulopathy
Condition
  • Multifocal Lymphangioendotheliomatosis With Thrombocytopenia
  • Cutaneovisceral Angiomatosis With Thrombocytopenia
  • Vascular Anomaly With Thrombocytopenia
  • Hemangiomas
Intervention Other: no intervention
no intervention - observational only
Study Groups/Cohorts Vascular Anomaly with Coagulopathy
All patients diagnosed with Multifocal lymphangioendotheliomatosis with thrombocytopenia (MLT) or with a vascular anomaly with coagulopathy
Intervention: Other: no intervention
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: December 18, 2007)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date April 5, 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects with a vascular anomaly with coagulopathy

Exclusion Criteria:

  • Subjects without a vascular anomaly with coagulopathy
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older 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 NCT00576888
Other Study ID Numbers CHW07/226
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Beth A Drolet, MD, Medical College of Wisconsin
Study Sponsor Medical College of Wisconsin
Collaborators Not Provided
Investigators
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
PRS Account Medical College of Wisconsin
Verification Date September 2019