Development of a New Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Death Rates
|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: NCT04474184|
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : May 24, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Endometrial Carcinoma||Procedure: Biospecimen Collection Behavioral: Focus Group Other: Survey Administration||Phase 1|
I. To conduct focus groups to elicit perceptions and knowledge among African American women (AAW) and white women (WW) concerning abnormal uterine bleeding (AUB)/post-menopausal bleeding (PMB), endometrial cancer (EC) risk factors, barriers to seeking medical evaluation, sources of medical information and acceptance and feasibility of tampon self-collection for laboratory testing.
II. To perform a demonstration project of tampon self-collection from 25 AAW and 25 WW with AUB/PMB in Jacksonville.
AIM 1: Participants attend a focus group over 2 hours about endometrial cancer including knowledge of abnormal uterine bleeding, post-menopausal bleeding, risk factors, sources of medical information, barriers to seeking gynecologic care, and acceptance of tampon self-collection for endometrial cancer detection.
AIM 2: Participants receive a tampon kit for collection of vaginal samples.
After completion of study enrollment, participants may be followed up annually for 10 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of a Novel Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Mortality|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Aim 1 (focus group)
Participants attend a focus group over 2 hours about endometrial cancer including knowledge of abnormal uterine bleeding, post-menopausal bleeding, risk factors, sources of medical information, barriers to seeking gynecologic care, and acceptance of tampon self-collection for endometrial cancer detection.
Behavioral: Focus Group
Attend focus group
Other: Survey Administration
Experimental: Aim 2 (vaginal kit)
Participants receive a tampon kit for collection of vaginal samples.
Procedure: Biospecimen Collection
Receive vaginal kit for biospecimen collection
Other: Survey Administration
- Differences in views on endometrial cancer (EC) risk between African American and white women and whether the former would be willing to participate in tampon testing (Aim 1) [ Time Frame: Up to 12 months ]Survey data will be reported as frequencies and proportions to describe the sample. Survey data will also be used to aid in interpretation of the qualitative data as appropriate.
- Total deoxyribonucleic acid (DNA) (Aim 2) [ Time Frame: Up to 12 months ]
- Endometrial DNA (Aim 2) [ Time Frame: Up to 12 months ]
- Detection of EC-specific methylation markers (Aim 2) [ Time Frame: Up to 12 months ]Will test samples for top EC-specific DNA methylation markers using methylation-specific polymerase chain reaction and provide descriptive statistics for all measurements (mean, median, standard deviation). Will assess the percentage of samples that yield > 500 ng amplifiable DNA, which suffices for methylation assays.
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|Ages Eligible for Study:||40 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- AIM 1: Self-identified white women (WW) or African American women (AAW) (will record Hispanic ethnicity)
- AIM 2: Self-reported history of abnormal uterine bleeding (AUB) or post-menopausal bleeding (PMB)
- AIM 1: Women who do not identify as WW or AAW
- AIM 1: Women who are unable to speak and read English
- AIM 2: Prior hysterectomy
- AIM 2: Prior pelvic radiation or are unwilling to comply with instructions
- AIM 2: Pregnant women
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): NCT04474184
|United States, Florida|
|Mayo Clinic in Florida||Recruiting|
|Jacksonville, Florida, United States, 32224-9980|
|Contact: Clinical Trials Referral Office 855-776-0015 email@example.com|
|Principal Investigator: Mark E. Sherman|
|Principal Investigator:||Mark E Sherman||Mayo Clinic|
|Responsible Party:||Mayo Clinic|
|Other Study ID Numbers:||
NCI-2020-04756 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19-001140 ( Other Identifier: Mayo Clinic in Florida )
P30CA015083 ( U.S. NIH Grant/Contract )
|First Posted:||July 16, 2020 Key Record Dates|
|Last Update Posted:||May 24, 2022|
|Last Verified:||February 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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