RecruitingNCT03538665

The DETECT Study: Discovery and Evaluation of Testing for Endometrial and Ovarian Cancer in 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


Sponsor

University of Alabama at Birmingham

Enrollment

1,500 participants

Start Date

Jul 1, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

BACKGROUND: Endometrial cancer is a common and deadly cancer for women. It is getting more common and deadly because risk factors like age and obesity are increasing. Also, this cancer is becoming more common and deadly for black women than white women. Researchers want to find better ways to take samples and test them for this cancer. They want to study this for a racially diverse population. One way to take samples might be from a tampon. If identified early, endometrial cancer can be highly curable; however, the earliest stages may be asymptomatic, and clinical symptoms are often missed. Combining sensitive molecular testing approaches with non-invasive sampling techniques may to lead to the development of novel endometrial cancer early detection approaches with the potential to overcome disparities in access to care and time to diagnosis and treatment. In contrast to endometrial cancer, ovarian cancer is typically detected at advanced stages with poor survival since symptoms manifest only late in the disease process and are very unspecific. Racial disparities in ovarian cancer incidence and mortality are also much less pronounced. Racial disparities can manifest particularly when screening, symptom appraisal and early detection, and effective treatment interventions have important roles in determining outcomes of cancers. OBJECTIVES: The purpose of this study is to see if it is possible and acceptable for individuals to have an endometrial or ovarian sample collected by using a tampon placed in the vagina. The investigators will look at DNA in these samples. DNA is the genetic information participants inherited from their parents. The investigators want to see whether the investigators can find changes in DNA and proteins related to endometrial or ovarian cancer from tampon samples. Tests on the samples from tampons will help to understand endometrial and ovarian cancer. The samples collected during this study will be used for research related to both endometrial and ovarian cancer and non-cancer conditions. ELIGIBILITY: Women at least ≥18 years undergoing clinically-indicated hysterectomy and/or bilateral salpingo-oophorectomy for endometrial or ovarian cancer, cancer precursors, or benign conditions. DESIGN: 1. Participants will put a tampon in their vagina at least 30 minutes before their surgery. 2. Participants will take a short survey. 3. The tampon will be collected during the surgery. 4. A small piece of tissue will be collected from the uterus +/- ovary that is removed in surgery. 5. Participants will give a blood sample. 6. Before or after surgery, participants will answer questions. These will be about their medical history and basic data such as age and race. 7. Researchers will follow participants medical records for up to 5 years after the study. Additional blood may be taken from patient if patient agrees. 8. Researchers will study the samples and tampons. They will compare how well cancer and other markers are detected between the samples.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether tampons can collect cells shed from the uterus and ovaries that might help detect endometrial (uterine) or ovarian cancer — potentially offering a non-invasive way to identify these cancers earlier. **You may be eligible if...** - You were born with female sex organs (including cisgender women and transmasculine individuals) - You are over 18 years old - You are scheduled for a hysterectomy (uterus removal) or removal of both ovaries at the University of Alabama Birmingham - You are able to read and understand English or Spanish and sign a consent form **You may NOT be eligible if...** - You are pregnant (pregnant patients are not candidates for gynecologic surgery) - You were not born with female sex organs (cisgender males and transfeminine individuals are not eligible as they do not have the anatomy relevant to these cancers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03538665


Related Trials