RECRUITING

HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic funding to conduct multi-institutional research (clinical trials and observational studies) on pediatric hydrocephalus. In addition to philanthropic funding, the HCRN has also received an NIH NINDS Challenge Grant to support the network infrastructure which allows for the conduct of this and other network studies. The HCRN consists of multiple Clinical Centers and the Data Coordinating Center (DCC). The HCRN Core Data Project will obtain data about all neurosurgical hydrocephalus events from the network Clinical Centers, and create a database to be used by HCRN investigators. The ongoing maintenance of the Core Data Project serves two main purposes: 1) it will help investigators understand the variability, progression, and current treatment practices for hydrocephalus in children, with an ultimate goal of better guiding and assessing therapeutic intervention and providing recommendations on patient care and, 2) it will provide pilot and descriptive data necessary for hypothesis generation and study design (i.e. preliminary power analyses, recruitment projections) for studies under development by the HCRN. This multi-institutional database will be maintained throughout the lifetime of the HCRN, and may be useful for tracking trends in pediatric hydrocephalus over time. The Core Data Project will be an invaluable resource to the HCRN and will help stimulate new research protocols, identify potential need for future expansion of the network to incorporate additional patient populations, and provide a descriptive understanding of children with hydrocephalus cared for within the network.

Official Title

HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)

Quick Facts

Study Start:2008-04
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00670735

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.

Ages Eligible for Study:Not specified to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ventriculoperitoneal shunt
  2. * Ventriculoatrial shunt
  3. * Ventriculopleural shunt
  4. * Arachnoid cyst shunts
  5. * Subdural shunts
  6. * Lumboperitoneal shunts
  7. * Shunts replaced after treatment of infection
  8. * Shunts exposed during an operations but not revised
  9. * Endoscopic third ventriculostomies
  10. * Ommaya reservoir(s)
  11. * Ventricular access devices/reservoirs
  12. * Subgaleal shunts.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Marcie Langley
CONTACT
801-662-5364
marcie.langley@hsc.utah.edu

Principal Investigator

Jay Riva-Cambrin, MD
STUDY_CHAIR
Alberta Children's Hospital
Abhaya Kulkarni, MD, PhD
PRINCIPAL_INVESTIGATOR
Sick Children's Hospital, Toronto, Ontario
Tamara D Simon, MD, MSPH
PRINCIPAL_INVESTIGATOR
University of Washington / Seattle Children's Hospital
Richard Holubkov, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

Children's Hospital of Alabama, University of Alabama
Birmingham, Alabama, 35233
United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
United States
St. Louis Children's Hospital
St. Louis, Missouri, 63110
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Primary Children's Hospital
Salt Lake City, Utah, 84118
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Jay Riva-Cambrin, MD, STUDY_CHAIR, Alberta Children's Hospital
  • Abhaya Kulkarni, MD, PhD, PRINCIPAL_INVESTIGATOR, Sick Children's Hospital, Toronto, Ontario
  • Tamara D Simon, MD, MSPH, PRINCIPAL_INVESTIGATOR, University of Washington / Seattle Children's Hospital
  • Richard Holubkov, Ph.D., PRINCIPAL_INVESTIGATOR, University of Utah

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 Registration Dates

Study Start Date2008-04
Study Completion Date2029-12

Study Record Updates

Study Start Date2008-04
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • Pediatric Hydrocephalus

Additional Relevant MeSH Terms

  • Pediatric Hydrocephalus