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Development of a Research Infrastructure for Understanding and Addressing Multiple Myeloma Disparities (MEDULLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04314752
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Cancer Registry of Greater California
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
The objectives of the proposed study are to develop and evaluate protocols for ethnic/racial minority-specific research using cancer registry data. In conjunction with the Cancer Registry of Greater California (CRGC), the investigators have developed procedures to identify, recruit, and survey ethnic/racial minority patients with MM. To pilot the study, the investigators aim initially to test the feasibility of this protocol by contacting 400 eligible patients (100 African Americans, 100 Latinos, 100 Asian American/Native Hawaiian/Pacific Islander-AANHPI and 100 non-Hispanic Whites as a comparison group) to conduct a pilot survey through which will ascertain etiological and survival-related factors for MM. Ultimately, the investigators hope the findings from this pilot will yield insight into the best practices for recruiting minorities with MM and serve as the basis for larger population-based studies of MM etiology and survival.

Condition or disease
Multiple Myeloma

Detailed Description:

Eligible patients will include African Americans, Latinos and AANHPIs who were diagnosed with a first primary, pathologically confirmed MM within the previous five years and who were at least 21 years of age at the time of diagnosis. Investigators will also include, as a comparison group, non-Hispanic White patients. Patients must have been diagnosed in one of the 48 counties of California. Patients must be alive at the time of study and able to provide informed consent. The research team will not include those who are unable to consent, pregnant women, or prisoners.

Initially, investigators will randomly select 100 eligible patients from each race/ethnicity mentioned above to participate in the pilot study. Once the pilot is completed, the investigators will aim to contact all eligible patients reported to the Cancer Registry of Greater California (CRGC) until 2024.

Drs. Carvajal-Carmona and Cress have coordinated with MEDULLA investigators and CRGC research staff to develop a questionnaire for racial/ethnic minorities with Multiple Myeloma. The survey focuses on demographics, risk factors, cancer treatment, quality of life, and social determinants of health. All survey items are adapted from previously tested and validated surveys. The survey is expected to take approximately 30-45 minutes to complete.

CRGC staff, under Dr. Cress supervision, will identify eligible participants using the criteria described above based on diagnostic information in the CRGC database. The research team will be following California Cancer Registry policies and procedures for release of data. CRGC staff will extract patients contact information from the registry and will provide this information to research staff at UC Davis, who will work under Dr. Carvajal-Carmona's supervision.

The UC Davis Research team will initially mail each eligible participants a postcard and a survey study packet that will include: 1) Simple instruction sheet 2) An introductory letter that details the study 3) Information sheet that details on informed consent 4) Survey instruction sheet 5) A paper copy of the survey 5) Incentive selection sheet and option to continue to the second part of study 6) Brochures about the cancer registry and the UC Davis Comprehensive Cancer Center, and return pre-paid envelope.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 4 Years
Official Title: Development of a Research Infrastructure for Understanding and Addressing Multiple Myeloma Disparities
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma




Primary Outcome Measures :
  1. Review the response rate of mailed out surveys, compared by race/ethnicity and disease status [ Time Frame: 2024 ]
    Response Rate in percentage

  2. Response rate for saliva kits compared to survey response and determine if there is a disparity in participation between race/ethnic groups [ Time Frame: 2024 ]
    Response Rates in percentage


Biospecimen Retention:   Samples With DNA
Study team will collect 2ml of saliva from participants who consent to the biospecimen collection portion of the study. Saliva will be used for genetic and genomic research


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 Latinos 100 African American 100 Asian American/Native Hawaiian/Pacific Islander 100 Non-Hispanic White
Criteria

Inclusion Criteria:

  • Diagnosed with a first primary pathologically confirmed case of Multiple Myeloma within the previous 5 years
  • At least 21 years of age at the time of diagnosis
  • Must have been diagnosed in one of the 48 counties in California
  • Participant must be alive
  • Identify as one of the following: African American, Latino, Asian American/Native Hawaiian/Pacific Islander, Non-Hispanic White

Exclusion Criteria:

  • People who have not been diagnosed with Multiple Myeloma
  • Under the age of 21
  • Pregnant
  • Prisoner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314752


Contacts
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Contact: Luis Carvajal-Carmona, PhD 5307529654 lgcarvajal@ucdavis.edu
Contact: Fabian Perez, MPH 9167344563 fpperez@ucdavis.edu

Locations
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United States, California
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Luis Carvajal-Carmona, PhD    530-752-9654    lgcarvajal@ucdavis.edu   
Contact: Fabian Perez, MPH    9167344560    fpperez@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Cancer Registry of Greater California
Investigators
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Principal Investigator: Luis Carvajal-Carmona, PhD University of California, Davis
Principal Investigator: Rosemary Cress, DrPh MPH Cancer Registry of California
  Study Documents (Full-Text)

Documents provided by University of California, Davis:
Study Protocol  [PDF] December 2, 2019
Informed Consent Form  [PDF] December 2, 2019

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04314752    
Other Study ID Numbers: 1487154
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Once everything is de-identified, we may share data or genetic information with dbGaP, a database of genotypes and phenotypes through the NIH for additional research. Protocols for additional research will be submitted to IRB for approval before use of this data or genetic information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases