Clinical Trial: B-Cell Hematologic Malignancy Vaccination Registry

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational [Patient Registry]

Official Title: B-Cell Hematologic Malignancy Vaccination Registry

Brief Summary: The goal of this study is to develop a vaccination registry system for Aurora Health Care patients newly diagnosed with MM and other B-Cell Hematologic Malignancies in order to prospectively characterize vaccination history and outcomes such as infection in these patients at Aurora Health Care. Additionally hospitalization rates, cost analysis, infection (influenza, pneumonia, other) related to vaccination in this patient population will be evaluated.

Detailed Summary:

This is a prospective registry study on the immunizations in patients with B-Cell Hematologic Malignancies at Aurora Health Care. This observational study will consist of prospective medical record review of Aurora Health Care patients newly diagnosed B-Cell Hematologic Malignancies and will be used to characterize vaccination history, infection rate, and hospitalization rate. This is the second study in the series of studies designed to provide important information about the best way and time to vaccinate patients with MM and similar cancers to flu and pneumonia and to gather additional information about immune function in this patient population.

The registry will include all adult patients who are newly diagnosed with the following B-Cell Hematologic Malignancies: Monoclonal gammopathy of undetermined significance (MGUS), Smoldering multiple myeloma (SMM), Multiple myeloma (MM), Waldenstroms Macroglobulinemia (WM), Monoclonal B-cell lymphocytosis (MBL), Chronic lymphocytic leukemia (CLL), or B-Cell Non-Hodgkin lymphoma (NHL). The prevalence of newly diagnosed B-Cell Hematologic Malignancies at Aurora Health Care is approximately 1000 patients annually. This registry will be ongoing to collect real time data, with no definite sample size planned; however, data will be collected for at least 10 years. This time frame is based on Surveillance, Epidemiology, and End Results Program (SEER) data. There is a 50% survival rate at 5 years after diagnosis for MM, so the 10 year time frame will be able to capture long term outcome in patients.

Medical record information will be obtained through electronic data capture by Aurora Health Care staff with access to the electronic medical records. Data will be manually reviewed by the coordinator, Investigator and co-investigators for accuracy and completeness, to the extent available
Sponsor: Michael A. Thompson, MD, PhD

Current Primary Outcome: vaccination history [ Time Frame: 10 years ]

Information regarding vaccination history will be collected historically and throughout data collection, expected to continue for about 10 years.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Survival [ Time Frame: 10 years ]
    Survival status will be collected throughout data collection, expected to continue for about 10 years.
  • infection [ Time Frame: 10 years ]
    Information about any infections (influenza, pneumonia, other) such as numbers, types will be collected throughout data collection, expected to continue for about 10 years.
  • hospitalization rates [ Time Frame: 10 years ]
    Information regarding hospitalization will be collected throughout data collection, expected to continue for about 10 years.


Original Secondary Outcome: Same as current

Information By: Aurora Health Care

Dates:
Date Received: November 20, 2014
Date Started: August 2014
Date Completion: December 2025
Last Updated: December 28, 2016
Last Verified: December 2016