Endometrial Cancer Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | August 11, 2025 |
Est. primary completion date | August 11, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 99 Years |
Eligibility | - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | National Cancer Institute (NCI) |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endometrial Cancer | Women with histologically confirmed diagnosis of endometrial cancer | Enrollment or at time of surgery | |
Primary | Endometrial cancer precursors | Women with histologically confirmed diagnosis of precursors (e.g., atypical hyperplasia) | Enrollment or at time of surgery | |
Primary | 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 | Acceptability of tampon sampling | Women will be given a 10 question survey to assess acceptability of tampon sampling | Prior to surgery | |
Secondary | 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 |
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