Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04314752 |
| Other study ID # |
1487154 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
May 30, 2025 |
Study information
| Verified date |
August 2023 |
| Source |
University of California, Davis |
| Contact |
Luis Carvajal-Carmona, PhD |
| Phone |
5307529654 |
| Email |
lgcarvajal[@]ucdavis.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
The next phase of this study is to expand the study to all 3 California Cancer Registries,
including the Greater Bay Area Cancer Registry and the Los Angeles Cancer Surveillance
Program and Cancer Registry of Greater California. We will increase the sample size to
recruit atleast 1000 participants per racial/ethnic group. We will also request to increase
the scope of the study to also continue a survivorship cohort.
Description:
Eligible patients will include AAs, 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. We will also include, as a comparison group,
non-Hispanic White patients. Patients must have been diagnosed in one of counties of
California. Patients must be alive at the time of study and able to provide informed consent.
We will not include those who are unable to consent, pregnant women, or prisoners.
Initially, in the pilot phase, we randomly selected 100 eligible patients from each
race/ethnicity mentioned above to participate in the pilot study. As the pilot has been
completed, we now aim to contact at recruit 1,000 patients per race/ethnic group reported to
all three population cancer registries in the state, including the Greater Bay Area Cancer
Registry and the Los Angeles Cancer Surveillance Program and Cancer Registry of Greater
California until 2025. Patients diagnosis dates for the next phase of the study (June
2021-May 2025) will include diagnosis dates from 2018-2023, as there is a 2 year lag between
patients cancer diagnosis and cancer registries information recorded.
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.
