B-Cell Hematologic Malignancy Vaccination Registry
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Hematology, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/17/2019 |
| Start Date: | August 2014 |
| End Date: | December 2025 |
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.
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.
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 in the clinical medical record. Additionally, a biostatistician will assist
in data analysis.
Descriptive statistics such as counts, proportions or percentages for category variables and
mean and standard deviation for continuous variables will be computed for the all the
variables. Depending upon the distribution of the category variables appropriate statistical
tests such as chi-square and/or Fisher exact test will be used to find out the statistical
significance. For continuous variables an appropriate statistical test such as t-tests and/or
F test will be used.
This registry will be used for this research study, and may be queried for internal quality
improvement projects as well. The principal investigator will be responsible for the overall
monitoring of the data and safety of study participants/data integrity, with the assistance
of other study team members.
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 in the clinical medical record. Additionally, a biostatistician will assist
in data analysis.
Descriptive statistics such as counts, proportions or percentages for category variables and
mean and standard deviation for continuous variables will be computed for the all the
variables. Depending upon the distribution of the category variables appropriate statistical
tests such as chi-square and/or Fisher exact test will be used to find out the statistical
significance. For continuous variables an appropriate statistical test such as t-tests and/or
F test will be used.
This registry will be used for this research study, and may be queried for internal quality
improvement projects as well. The principal investigator will be responsible for the overall
monitoring of the data and safety of study participants/data integrity, with the assistance
of other study team members.
Inclusion Criteria:
- Adult patients at Aurora Health Care who are newly diagnosed with:
- 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).
Exclusion Criteria:
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