Endometrial Cancer Testing with Vaginal and Endometrial Cell Samples

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 12-003624
    NCT ID: NCT01793545
    Sponsor Protocol Number: 12-003624

About this study

Background:

  • Endometrial cancer is one of the most common gynecologic cancers. If it is caught at an early stage, it can be treated more easily. Women who have this type of cancer often have a history of irregular menstrual bleeding. They may also have abnormal findings during gynecologic exams. Pap smears and cervical cell collection may be able to collect cell samples for cancer testing. However, samples from the vagina or endometrium may produce more accurate results. Researchers want to collect vaginal and endometrial cell samples to improve their tests for and understanding of endometrial cancer.

Objectives:

  • To collect vaginal and endometrial cell samples to study endometrial cancer.

Eligibility:

  • Women at least 18 years of age who have had symptoms of abnormal uterine or post-menopausal bleeding, or abnormal ultrasound findings.

Design:

  • Participants will be screened with a physical exam and medical history.
  • Participants will have a pelvic exam. Before the exam, they will insert a small tampon in the vagina. The tampon will stay in place for about 10 to 30 minutes. The tampon will then be removed and collected for the study.
  • During the pelvic exam, tissue will be collected from the uterine lining with a special brush. An additional sample (biopsy) will be collected from the lining.
  • A blood sample will also be collected as part of the study.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

Women should meet at least one of the following criteria:

  • Abnormal uterine bleeding
  • Postmenopausal bleeding
  • 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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jamie Bakkum-Gamez, M.D.

Open for enrollment

Contact information:

Ann VanOosten

7751916

VanOosten.Ann@mayo.edu

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

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20119259

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