The DETECT Study: Discovery and Evaluation of Testing for Endometrial Cancer in Tampons
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03538665|
Recruitment Status : Not yet recruiting
First Posted : May 28, 2018
Last Update Posted : August 16, 2019
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. It is highly curable if it is identified early. But there may be no symptoms early or they may be missed. 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.
To see if it is possible and acceptable to collect an endometrial sample from women by using a tampon placed in the vagina.
Women at least 45 years old who are having a hysterectomy
Participants will put a tampon in their vagina at least 30 minutes before their surgery.
Participants will take a short survey.
The tampon will be collected during the surgery.
A small piece of tissue will be collected from the uterus that is removed in surgery.
Participants will give a blood sample.
Before or after surgery, participants will answer questions. These will be about their medical history and basic data such as age and race.
Researchers will follow participants medical records for up to 3 years after the study.
Researchers will study the samples and tampons. They will compare how well cancer and other markers are detected between the samples.
|Condition or disease|
|Endometrial Cancer Endometrial Cancer Precursors|
- Endometrial cancer is the most common and second deadliest gynecological cancer in women in the United States, with over 63,000 new cases and 11,000 deaths expected to occur in 2018. Unlike most cancers, endometrial cancer incidence and mortality are increasing, due to increases in risk factors such as obesity and population aging.
- Racial disparities in endometrial cancer incidence and mortality have been reported, with black or African American (henceforth referred to as black ) women experiencing more rapid increases in incidence, as well as a higher burden of endometrial cancer mortality compared to other racial/ethnic groups. The underlying basis for these disparities is likely multifactorial, involving biological differences, as well as clinical factors related to access to care, delayed diagnosis, and differences in treatment and surgical management.
- 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. We and others have recently shown that vaginal tampons offer an acceptable and feasible method for identifying molecular markers with high sensitivity and specificity for endometrial cancer. Importantly, these proof-of-principle studies have been conducted in predominantly non-Hispanic white (white) populations, and studies of molecular markers for endometrial cancer, including those involving vaginal tampons, are lacking in black women.
-The goal of this study is to evaluate the acceptability, feasibility, and clinical performance of vaginal tampon sampling for molecular testing of endometrial cancer early detection biomarkers in a racially diverse clinical population.
-Eligible participants will include women aged greater than or equal to 45 years undergoing clinically-indicated hysterectomy for endometrial cancer, endometrial cancer precursors, or benign conditions at the University of Alabama s Division of Gynecologic Oncology.
- This is a case-control study with prospective follow-up of the electronic health record or up to 3 years. Cases will be defined as women with histologically-confirmed endometrial cancer or cancer precursors diagnosed at hysterectomy. Controls will have no histologic evidence of endometrial cancer or endometrial cancer precursors diagnosed at hysterectomy.
- The primary endpoints of this study will be: 1) The acceptability and feasibility of vaginal tampon sampling in a racially diverse clinical population, assessed by evaluating approximately 10 items from a brief survey regarding tampon sampling and the DNA yield from the vaginal tampon, respectively and 2) The prevalence, sensitivity, and specificity of endometrial cancer driver mutations in tampon and tissue samples in cases and controls.
|Study Type :||Observational|
|Estimated Enrollment :||900 participants|
|Official Title:||The DETECT Study - Discovery and Evaluation of Testing for Endometrial Cancer in Tampons|
|Estimated Study Start Date :||August 21, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Women undergoing clinically-indicated hysterectomy for endometrial cancer or precursors
Women undergoing clinically-indicated hysterectomy for benign conditions
- Endometrial Cancer [ Time Frame: Enrollment or at time of surgery ]Women with histologically confirmed diagnosis of endometrial cancer
- Endometrial cancer precursors [ Time Frame: Enrollment or at time of surgery ]Women with histologically confirmed diagnosis of precursors (e.g., atypical hyperplasia)
- Non-malignant uterus [ Time Frame: Enrollment or at time of surgery ]Women with fibroids, polyps, endometrial hyperplasia without atypia, adenomyosis, normal endometrium, or other benign conditions determined by histology and/or clinical imaging.
- Acceptability of tampon sampling [ Time Frame: Prior to surgery ]Women will be given a 10 question survey to assess acceptability of tampon sampling
- Feasibility of tampon sampling [ Time Frame: During and immediately after surgery ]The feasibility of tampon sampling will be determined by successful tampon insertion according to protocol prior to surgery and sufficient DNA yield (e.g., 1-2ug) from the tampon sample.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538665
|Contact: Nicolas Wentzensen, M.D.||(301) email@example.com|
|United States, Alabama|
|University of Alabama||Not yet recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Warner Huh 205-996-4662 firstname.lastname@example.org|
|Principal Investigator:||Nicolas Wentzensen, M.D.||National Cancer Institute (NCI)|