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

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. 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.

Objective:

To see if it is possible and acceptable to collect an endometrial sample from women by using a tampon placed in the vagina.

Eligibility:

Women at least 45 years old who are having a hysterectomy

Design:

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.

Study Overview

• Status: Recruiting
• Conditions: Endometrial Cancer; Endometrial Cancer Precursors

Detailed Description

BACKGROUND:

• 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.

OBJECTIVES:

-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.

ELIGIBILITY:

-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.

DESIGN:

• 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
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Megan A Clarke-Corso, Ph.D.; Phone Number: (240) 276-7823; Email: megan.clarke@nih.gov
• Study Contact Backup: Name: Rebecca C Arend, MD; Phone Number: (917) 532-5370; Email: rarend@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama
      • Contact: Warner Huh; Phone Number: 205-934-4986; Email: whuh@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women undergoing clinically-indicated hysterectomy for endometrial cancer, cancer precursors, or benign uterine conditions at the University of Alabama Division of Gynecologic Oncology who are age 45 years and older.

Description

• INCLUSION CRITERIA:
• Women scheduled for hysterectomy for endometrial cancer, endometrial cancer precursors, or benign conditions at the University of Alabama Birmingham s Division of Gynecologic Oncology.
• Age greater than or equal to 45 years. We have chosen this age range to include both peri- and postmenopausal women, who are at greatest risk for endometrial cancer. Women younger than 45 years of age will not be included because they are at very low risk for endometrial cancer and therefore are likely not the target population for early detection of endometrial cancer.
• Ability of subject 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 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.
• Men are not eligible for this study as this is a disease of a female organ.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cases; Women undergoing clinically-indicated hysterectomy for endometrial cancer or precursors
Controls; Women undergoing clinically-indicated hysterectomy for benign conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial Cancer	Women with histologically confirmed diagnosis of endometrial cancer	Enrollment or at time of surgery
Endometrial cancer precursors	Women with histologically confirmed diagnosis of precursors (e.g., atypical hyperplasia)	Enrollment or at time of surgery
Non-malignant uterus	Women with fibroids, polyps, endometrial hyperplasia without atypia, adenomyosis, normal endometrium, or other benign conditions determined by histology and/or clinical imaging.	Enrollment or at time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of tampon sampling	Women will be given a 10 question survey to assess acceptability of tampon sampling	Prior to surgery
Feasibility of tampon sampling	The feasibility of tampon sampling will be determined by successful tampon insertion according to protocol prior to surgery and sufficient DNA yield (e.g., 1-2 microgram) from the tampon sample.	During and immediately after surgery

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Rebecca C Arend, MD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Bakkum-Gamez JN, Wentzensen N, Maurer MJ, Hawthorne KM, Voss JS, Kroneman TN, Famuyide AO, Clayton AC, Halling KC, Kerr SE, Cliby WA, Dowdy SC, Kipp BR, Mariani A, Oberg AL, Podratz KC, Shridhar V, Sherman ME. Detection of endometrial cancer via molecular analysis of DNA collected with vaginal tampons. Gynecol Oncol. 2015 Apr;137(1):14-22. doi: 10.1016/j.ygyno.2015.01.552. Epub 2015 Feb 10.
• Erickson BK, Kinde I, Dobbin ZC, Wang Y, Martin JY, Alvarez RD, Conner MG, Huh WK, Roden RBS, Kinzler KW, Papadopoulos N, Vogelstein B, Diaz LA Jr, Landen CN Jr. Detection of somatic TP53 mutations in tampons of patients with high-grade serous ovarian cancer. Obstet Gynecol. 2014 Nov;124(5):881-885. doi: 10.1097/AOG.0000000000000484.
• Nair N, Camacho-Vanegas O, Rykunov D, Dashkoff M, Camacho SC, Schumacher CA, Irish JC, Harkins TT, Freeman E, Garcia I, Pereira E, Kendall S, Belfer R, Kalir T, Sebra R, Reva B, Dottino P, Martignetti JA. Genomic Analysis of Uterine Lavage Fluid Detects Early Endometrial Cancers and Reveals a Prevalent Landscape of Driver Mutations in Women without Histopathologic Evidence of Cancer: A Prospective Cross-Sectional Study. PLoS Med. 2016 Dec 27;13(12):e1002206. doi: 10.1371/journal.pmed.1002206. eCollection 2016 Dec.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Estimated): August 11, 2025
• Study Completion (Estimated): August 11, 2025

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Natural History; Endometrial Cancer; Early Detection; Somatic Mutations; Tampon Sampling; Tissue Discovery
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms
• Other Study ID Numbers: 999918106; Z01CP010124-21 (U.S. NIH Grant/Contract: National Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No