Clinical trial · Interventional
Development of a New Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Death Rates
Development of a Novel Early Detection Test to Reduce Racial Disparities in Endometrial Cancer (EC) Mortality
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Focus Group | Behavioral | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aim 1 (focus group)
- description
- 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.
- interventionNames
- Behavioral: Focus Group
- Other: Survey Administration
- type
- EXPERIMENTAL
- label
- Aim 2 (vaginal kit)
- description
- Participants receive a tampon kit for collection of vaginal samples.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Survey Administration
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available