NCT01793545

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,932

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2020

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

3.8 years

First QC Date

February 14, 2013

Last Update Submit

November 16, 2020

Conditions

Endometrial CancerGynecological Cancers

Keywords

Endometrial CancerGynecological CancersScreening

Outcome Measures

Primary Outcomes (1)

  • Endometrial Cancer and Endometrial Hyper Plasia

    Histologically confirmed endometrial cancer or endometrial hyperplasia

    1 to 5 years

Study Arms (1)

Endometrial Cancer Cohort

Women with abnormal bleeding or other conditions associated with increased risk ofendometrial cancer.

Eligibility Criteria

Age45 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with abnormal bleeding or other conditions associated with increased risk of endometrial cancer.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

  • Armstrong K, Randall TC, Polsky D, Moye E, Silber JH. Racial differences in surgeons and hospitals for endometrial cancer treatment. Med Care. 2011 Feb;49(2):207-14. doi: 10.1097/MLR.0b013e3182019123.

    PMID: 21150796BACKGROUND

  • Dimitraki M, Tsikouras P, Bouchlariotou S, Dafopoulos A, Liberis V, Maroulis G, Teichmann AT. Clinical evaluation of women with PMB. Is it always necessary an endometrial biopsy to be performed? A review of the literature. Arch Gynecol Obstet. 2011 Feb;283(2):261-6. doi: 10.1007/s00404-010-1601-3. Epub 2010 Aug 4.

    PMID: 20683604BACKGROUND

  • Lacey JV Jr, Ioffe OB, Ronnett BM, Rush BB, Richesson DA, Chatterjee N, Langholz B, Glass AG, Sherman ME. Endometrial carcinoma risk among women diagnosed with endometrial hyperplasia: the 34-year experience in a large health plan. Br J Cancer. 2008 Jan 15;98(1):45-53. doi: 10.1038/sj.bjc.6604102. Epub 2007 Nov 20.

    PMID: 18026193BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Nicolas Wentzensen, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2013

First Posted

February 15, 2013

Study Start

February 11, 2013

Primary Completion

December 1, 2016

Study Completion

November 16, 2020

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations

US(1)