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Clinical Trials

Rare Benign Vascular Tumor Registry

Date Last Modified: 03-28-2006
Date First Published: 03-28-2006

Objectives

The purpose of this Registry is to learn more about the cause and outcome for rare vascular tumors.

The objectives of this Registry are:

  • To document the clinical course of rare benign vascular tumors
  • To establish a physician network to increase the understanding of rare benign vascular tumors
  • To determine the incidence and outcome of these rare benign vascular tumors
  • To get patient approval to be contacted for participation in future research studies

Accrual

Approximately 25-50 total patients per year will be enrolled in this Registry.

Inclusion / Exclusion Criteria

Inclusion Criteria

  • All patients with a rare benign vascular tumor will be eligible:
    • Kaposiform Hemangioendotheliomas
    • Tufted Angiomas
    • Congenital hemangiomas i.e. NICH's, RICH's
    • Hemangioendotheliomas (All types)
      Example: Epitheloid hemangioendotheliomas
  • Informed consent must be obtained according to local and federal guidelines

Exclusion Criteria

Patients with the following diagnosis of common vascular anomalies are excluded:

  • Arteriovenous malformations
  • Capillary malformations
  • Venous malformations
  • Hemangiomas (other than those listed in inclusion criteria)
  • Lymphatic malformations
  • Capillary-venous-lymphatic malformations or Klippel-Trénauny syndrome or Parkes-Weber syndrome
  • Pyogenic granulomas

Procedures

The Hemangioma and Vascular Malformation Center (HVMC) at Cincinnati Children's Hospital Medical Center is the Data Coordinating Center for the Rare Benign Vascular Tumors Registry for this research registry.

The following procedures will be followed for enrolling patients into this registry and entering data:

  • The investigative sites will obtain local IRB approval for the Registry study.
  • When a patient is consented to the study, the investigative site will submit the patient registration sheet by fax or mail to the Data Control Center.

How do I get more information?

For more information, contact:

Mary Sue Wentzel, RN
Cincinnati Children's Hospital Medical Center
Division of Hematology / Oncology
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Phone: 513-636-0944
marysue.wentzel@cchmc.org

  • Once eligibility is confirmed by the Data Control Center for the Rare Benign Vascular Tumors Registry, the patient is enrolled and the subject study number is faxed or emailed to the investigative site.
  • The investigative site will fill out the initial data forms and send the data forms with the additional information from the medical record, as described in Appendix I, by fax or mail to the Data Control Center at the address listed above. Cincinnati Children's utilizes the latest information security technology to ensure that all proprietary data is transmitted securely. The authorized data will be transmitted by sending an e-mail to the authorized recipient and attaching a zipped, password protected, MSAccess file. The password to the fill will not be sent in the body of an e-mail; rather the recipient will be notified of the password in a separate e-mail
  • Data will be entered into the Registry database by the Data Control Center's personnel.
  • After the initial registration data is sent, newly diagnosed patients will be contacted for information twice a year for the first year and yearly thereafter. Established patients will be contacted yearly. On occasion, we may contact the patient for clarification of submitted information.

Copies of the medical record will be kept for at the investigative site for at least 10 years.

*Obtaining Informed Consent via Telephone

  • It is not required that the patient be seen at an investigative site to enroll in this Registry.
  • To get informed consent from a patient not being seen at an investigative site: permission to mail or fax the consent document will be obtained from the patient / legal guardian when they telephone to be enrolled.
  • Once the patient/legal guardian receives the informed consent document, the person obtaining informed consent will call the patient/legal guardian for discussion of the study and consent document.
  • If consent is given, the telephone conversation regarding consent will be documented, witnessed, and signed by another member of the investigative site staff.
  • The patient / legal guardian must then sign and date the consent in his / her possession. The patient/legal guardian will mail the signed consent to the investigative site office (for mail or Express Service a pre-stamped or pre-billed envelope will be provided with a copy of the consent). The person who obtained the informed consent and the witness will sign and date the mailed copy when it arrives at the investigative site.

Approval Process for Use of Registry Data

The data obtained from the registry will be analyzed for current and future research studies.

  • A researcher requesting information only to determine the feasibility of a research project, will complete an application explaining what type of information they are seeking. They will also include an explanation of why this information is being requested.
  • If a researcher is requesting information for a research protocol, the application will be sent to the Steering Committee for scientific review and approval. The Steering Committee will consist of Dr. Denise Adams, a statistician and the Principal Investigator from each of the collaborating sites.
  • Once approved by the Steering Committee the researcher will obtain local IRB approval. A copy of the approval will be submitted to the Data Control Center at Cincinnati Children's Hospital Medical Center before the data is released.