A Study of Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples

Overview

About this study

The purpose of this study is to collect vaginal and endometrial cell samples to study endometrial cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Women at least 18 years of age.
  • Women who have had symptoms of abnormal uterine or post-menopausal bleeding, or abnormal ultrasound findings.
  • Thickened endometrial stripe.
  • Hereditary predisposition to endometrial cancer (e.g., HNPCC).
  • Women referred for endometrial biopsy to evaluate suspicion or high risk of endometrial cancer

Exclusion Criteria: 

  • Prior hysterectomy.
  • Pregnant women (there will be a verbal screen by the clinic nurse and the physician about a potential pregnancy and a pregnancy test may be conducted if there is any doubt).
  • Prior pelvic radiation. 
  • Cervical stenosis that renders Tao brush sampling impossible.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Mark Sherman, M.D.

Open for enrollment

Contact information:

Shantel Williams

(904)953-9727

Williams.Shantel@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Jamie Bakkum-Gamez, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Paul Magtibay, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

  • Endometrial carcinoma is the most distressing cause of abnormal vaginal bleeding. The intention of clinical management in the case of postmenopausal bleeding is to achieve an accurate diagnosis without overinvestigation. Read More on PubMed
  • To determine whether (1) black and white women with endometrial cancer were treated by different surgical specialties and in different types of hospitals and (2) differences in specialty and hospital type contributed to racial differences in survival. Read More on PubMed
  • Classifying endometrial hyperplasia (EH) according to the severity of glandular crowding (simple hyperplasia (SH) vs complex hyperplasia (CH)) and nuclear atypia (simple atypical hyperplasia (SAH) vs complex atypical hyperplasia (CAH)) should predict subsequent endometrial carcinoma risk, but data on progression are lacking. Our nested case-control study of EH progression included 138 cases, who were diagnosed with EH and then with carcinoma (1970-2003) at least 1 year (median, 6.5 years) later, and 241 controls, who were individually matched on age, date, and follow-up duration and counter-matched on EH classification. After centralised pathology panel and medical record review, we generated rate ratios (RRs) and 95% confidence intervals (CIs), adjusted for treatment and repeat biopsies. With disordered proliferative endometrium (DPEM) as the referent, AH significantly increased carcinoma risk (RR=14, 95% CI, 5-38). Risk was highest 1-5 years after AH (RR=48, 95% CI, 8-294), but remained elevated 5 or more years after AH (RR=3.5, 95% CI, 1.0-9.6). Progression risks for SH (RR=2.0, 95% CI, 0.9-4.5) and CH (RR=2.8, 95% CI, 1.0-7.9) were substantially lower and only slightly higher than the progression risk for DPEM. The higher progression risks for AH could foster management guidelines based on markedly different progression risks for atypical vs non-atypical EH. Read More on PubMed

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions