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

November 16, 2023 updated by: Mayo Clinic

Development of a Novel Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Mortality

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Survey Administration
Ancillary studies
Behavioral: Focus Group
Attend focus group
Experimental: Aim 2 (vaginal kit)
Participants receive a tampon kit for collection of vaginal samples.
Other: Survey Administration
Ancillary studies
Procedure: Biospecimen Collection
Receive vaginal kit for biospecimen collection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months
Total deoxyribonucleic acid (DNA) (Aim 2)
Time Frame: Up to 12 months
Up to 12 months
Endometrial DNA (Aim 2)
Time Frame: Up to 12 months
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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark E Sherman, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-001140 (Mayo Clinic in Florida)
  • NCI-2020-04756 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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