- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02298816
B-Cell Hematologic Malignancy Vaccination Registry (HMvax-Regist)
Study Overview
Status
Detailed Description
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.
Study Type
Contacts and Locations
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53233
- Aurora Health Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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).
Description
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:
- none
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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new B-Cell Hematologic Malignancy diagnosis
All adult patients who are newly diagnosed at Aurora Health Care 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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vaccination history
Time Frame: 10 years
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Information regarding vaccination history will be collected historically and throughout data collection, expected to continue for about 10 years.
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10 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival
Time Frame: 10 years
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Survival status will be collected throughout data collection, expected to continue for about 10 years.
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10 years
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infection
Time Frame: 10 years
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Information about any infections (influenza, pneumonia, other) such as numbers, types will be collected throughout data collection, expected to continue for about 10 years.
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10 years
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hospitalization rates
Time Frame: 10 years
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Information regarding hospitalization will be collected throughout data collection, expected to continue for about 10 years.
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10 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Thompson, MD, PhD, Aurora Health Care
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Pneumonia
- Vaccination
- Chronic lymphocytic leukemia (CLL)
- immunization
- Influenza, Human
- Smoldering multiple myeloma (SMM)
- Multiple myeloma (MM)
- Monoclonal gammopathy of undetermined significance (MGUS)
- Waldenstroms Macroglobulinemia (WM)
- Monoclonal B-cell lymphocytosis (MBL)
- B-Cell Non-Hodgkin lymphoma (NHL)
- B-Cell Hematologic Malignancies
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Disease Attributes
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Blood Protein Disorders
- Leukocyte Disorders
- Leukemia
- Leukemia, B-Cell
- Lymphoma
- Hypergammaglobulinemia
- Chronic Disease
- Leukocytosis
- Neoplasms
- Hematologic Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Lymphoma, Non-Hodgkin
- Waldenstrom Macroglobulinemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Paraproteinemias
- Monoclonal Gammopathy of Undetermined Significance
- Lymphocytosis
Other Study ID Numbers
- HMvax-registry:14-98E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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