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Development of a New Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Death Rates

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ClinicalTrials.gov Identifier: NCT04474184
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : May 24, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE July 13, 2020
First Posted Date  ICMJE July 16, 2020
Last Update Posted Date May 24, 2022
Actual Study Start Date  ICMJE February 1, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of a New Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Death Rates
Official Title  ICMJE Development of a Novel Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Mortality
Brief Summary This phase I trial investigates the development of a new early detection test to reduce racial disparities in endometrial cancer death rates. DNA samples collected from a tampon may be able to be used to detect endometrial cancer. Studying information from focus groups and vaginal samples of African American and white women may help researchers develop a less invasive and painful test to detect endometrial cancer. The purpose of this trial is to perform a demonstration project of tampon self-collection, assess percentage of samples returned; total and endometrial derived DNA quantity and quality, preliminarily test previously validated DNA methylation markers that may discriminate endometrial cancer from normal endometrium in tampon specimens.
Detailed Description

PRIMARY OBJECTIVES:

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.

OUTLINE:

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Endometrial Carcinoma
Intervention  ICMJE
  • Procedure: Biospecimen Collection
    Receive vaginal kit for biospecimen collection
  • Behavioral: Focus Group
    Attend focus group
  • Other: Survey Administration
    Ancillary studies
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Focus Group
    • Other: Survey Administration
  • Experimental: Aim 2 (vaginal kit)
    Participants receive a tampon kit for collection of vaginal samples.
    Interventions:
    • Procedure: Biospecimen Collection
    • Other: Survey Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2020)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04474184
Other Study ID Numbers  ICMJE 19-001140
NCI-2020-04756 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19-001140 ( Other Identifier: Mayo Clinic in Florida )
P30CA015083 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mayo Clinic
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mayo Clinic
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Mark E Sherman Mayo Clinic
PRS Account Mayo Clinic
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP