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

NCT03538665 | Recruiting

• 2 other identifiers: 999918106Z01CP010124-21
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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. 1.Participants will put a tampon in their vagina at least 30 minutes before their surgery.
2. 2.Participants will take a short survey.
3. 3.The tampon will be collected during the surgery.
4. 4.A small piece of tissue will be collected from the uterus +/- ovary that is removed in surgery.
5. 5.Participants will give a blood sample.
6. 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. 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. 8.Researchers will study the samples and tampons. They will compare how well cancer and other markers are detected between the samples.

Conditions

Endometrial Cancer; Endometrial Cancer Precursors; Ovarian Cancer; Complex Atypical Endometrial Hyperplasia

Keywords

Endometrial Cancer; Somatic Mutations; Early Detection; Tampon Sampling; Tissue Discovery; Natural History; Ovarian Cancer; Screening Tool

Outcome Measures

Primary Outcomes (3)

• Endometrial Cancer

  Women with histologically confirmed diagnosis of endometrial or ovarian 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 Outcomes (2)

• Acceptability of tampon sampling

  Prior to surgery

• Feasibility of tampon sampling

  During and immediately after surgery

Study Arms (2)

Cases

Women undergoing clinically-indicated hysterectomy +/- bilateral salpingo-oophorectomy for endometrial or ovarian cancer or precursors

Controls

Women undergoing clinically-indicated hysterectomy for benign conditions

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals \>18 years of age 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 25677060 BACKGROUND

• 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.

  PMID: 25437714 BACKGROUND

• 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.

  PMID: 28027320 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Rebecca C Arend, MD, MSPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca C Arend, MD, MSPH

CONTACT

(205) 934-5370; rarend@uabmc.edu

Megan A Clarke-Corso, Ph.D.

CONTACT

(240) 276-7823; megan.clarke@nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: May 29, 2018
• Study Start: July 1, 2019
• Primary Completion (Estimated): August 11, 2026
• Study Completion (Estimated): August 11, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

US (1)