Testing for endometrial and ovarian cancer using tampons
The DETECT Study - Discovery and Evaluation of Testing for Endometrial and Ovarian Cancer in Tampons: Tampon and Tissue Sampling to Evaluate Markers for Detection of Endometrial and Ovarian Cancer
University of Alabama at Birmingham · NCT03538665
This study is testing whether using tampons to collect samples can help find endometrial and ovarian cancers earlier in a diverse group of people who are having surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT03538665 on ClinicalTrials.gov |
What this trial studies
This study aims to explore innovative methods for early detection of endometrial and ovarian cancers by utilizing tampon sampling. Researchers will analyze samples from individuals scheduled for hysterectomy or bilateral salpingo-oophorectomy, focusing on a racially diverse population to address disparities in cancer incidence and outcomes. The study seeks to combine sensitive molecular testing with non-invasive sampling techniques to improve early detection rates, particularly in high-risk groups. By identifying cancer at earlier stages, the research hopes to enhance treatment options and survival rates.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals born with female sex organs who are scheduled for hysterectomy or bilateral salpingo-oophorectomy and are over 18 years old.
Not a fit: Patients who do not have the ability to understand the study or cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of endometrial and ovarian cancers, significantly improving patient outcomes.
How similar studies have performed: While the approach of using tampon sampling for cancer detection is novel, similar studies have shown promise in utilizing non-invasive methods for early cancer detection.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA: * Individuals born with female sex organs (uterus, ovaries, including cis-gender female and transmasculine individuals, hereafter referred to as "women") scheduled for hysterectomy or bilateral salpingo-oopherectomy at the University of Alabama Birmingham's Division of Gynecologic Oncology or Department of Gynecology * Age \>18 years. We have chosen this age range to include both peri- and postmenopausal women, who are at greatest risk for endometrial cancer. * Ability of study participant to understand and the willingness to sign a written informed consent document. Women who do not meet this criterion include potential participants who do not speak English or Spanish, or have physical, mental, or emotional problems that prevent them from comprehending the nature of the study. If the potential participant has trouble reading the document, the designated study staff person may read the document to the patient, to include the basic elements of the informed consent document, per 45 CFR §46.116 (a). EXCLUSION CRITERIA: * Women who are pregnant are excluded from gynecologic surgery and are therefore not eligible to participate. * Individuals who were not born with female sex organs at birth (i.e., cis-gender males and transfeminine individuals) are not eligible for this study as they are not at risk for developing endometrial and ovarian cancer.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Principal investigator: Rebecca C Arend, MD, MSPH — University of Alabama at Birmingham
- Study coordinator: Rebecca C Arend, MD, MSPH
- Email: rarend@uabmc.edu
- Phone: (205) 934-5370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometrial Cancer, Endometrial Cancer Precursors, Ovarian Cancer, Complex Atypical Endometrial Hyperplasia, Somatic Mutations, Early Detection, Tampon Sampling, Tissue Discovery