Endometrial CancerNCT01793545
Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples
An observational study of Endometrial Cancer and Gynecological Cancers, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 120 years, women only
- Conditions the study is for
- Endometrial Cancer, Gynecological Cancers
- How many people
- 1,932 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2013to 16 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with abnormal bleeding or other conditions associated with increased risk of endometrial cancer.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methylation Markers for Natural History and Early Detection of Endometrial Cancer
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.
Read more
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.
Read the detailed description
Endometrial cancer will account for approximately 47,310 incident cases and 8,010 related deaths in 2012. Most endometrial cancers develop slowly through progression of well characterized precursors, many of which regress with progesterone treatment or are curable with hysterectomy. Thus, early detection of endometrial cancer precursors can prevent many endometrial cancers and reduce mortality. Using DNA methylation profiling in the Polish Endometrial Cancer Study (PECS) and the Benign Reproductive Tissue Evaluation (BRTE) Study, we identified a panel of markers that is strongly and specifically linked to endometrial cancer. Concurrently, we have developed two sampling methods for detecting endometrial cancer and its precursors via DNA methylation analysis: vaginal tampons and endometrial brushings. Preliminary data demonstrate that DNA methylation markers are detectable in tampons and endometrial brushings and can identify women with endometrial cancer. We propose to extend the effort by collecting vaginal tampons and endometrial brushings from about 2000 women who are at increased risk of endometrial cancer and who present at the Mayo Clinic Division of Medical Gynecology. We will test our candidate panel of DNA methylation markers in this population and evaluate the clinical performance to detect endometrial hyperplasia and endometrial cancer. Success of this project could lead to development of early detection tests, including self-sampling strategies that would improve management of abnormal vaginal bleeding, endometrial cancer and its precursors.
- Conditions
- Endometrial Cancer, Gynecological Cancers
- Keywords
- Endometrial Cancer, Gynecological Cancers, Screening
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial Cancer Cohort | Women with abnormal bleeding or other conditions associated with increased risk ofendometrial cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Cancer and Endometrial Hyper Plasia
Histologically confirmed endometrial cancer or endometrial hyperplasia
Measured: 1 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start11 Feb 2013
- Primary completion1 Dec 2016
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,932 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Nicolas Wentzensen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793545
- Sponsor's protocol ID
- 999913073
- Other IDs
- 13-C-N073
- Status last verified
- Nov 2020
- First submitted
- 14 Feb 2013
- Last updated
- 17 Nov 2020
- Results posted
- No
Publications
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.
PubMed 21150796Dimitraki 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.
PubMed 20683604Lacey 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.
PubMed 18026193
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylation Markers for Natural History and Early Detection of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01793545
- Acronym / sponsor ID
- 999913073
- Conditions
- Endometrial Cancer, Gynecological Cancers
- Keywords
- Endometrial Cancer, Gynecological Cancers, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,932 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- Mayo Clinic
- Study start
- 11 Feb 2013 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Endometrial cancer will account for approximately 47,310 incident cases and 8,010 related deaths in 2012. Most endometrial cancers develop slowly through progression of well characterized precursors, many of which regress with progesterone treatment or are curable with hysterectomy. Thus, early detection of endometrial cancer precursors can prevent many endometrial cancers and reduce mortality. Using DNA methylation profiling in the Polish Endometrial Cancer Study (PECS) and the Benign Reproductive Tissue Evaluation (BRTE) Study, we identified a panel of markers that is strongly and specifically linked to endometrial cancer. Concurrently, we have developed two sampling methods for detecting endometrial cancer and its precursors via DNA methylation analysis: vaginal tampons and endometrial brushings. Preliminary data demonstrate that DNA methylation markers are detectable in tampons and endometrial brushings and can identify women with endometrial cancer. We propose to extend the effort by collecting vaginal tampons and endometrial brushings from about 2000 women who are at increased risk of endometrial cancer and who present at the Mayo Clinic Division of Medical Gynecology. We will test our candidate panel of DNA methylation markers in this population and evaluate the clinical performance to detect endometrial hyperplasia and endometrial cancer. Success of this project could lead to development of early detection tests, including self-sampling strategies that would improve management of abnormal vaginal bleeding, endometrial cancer and its precursors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial Cancer Cohort | – | –Women with abnormal bleeding or other conditions associated with increased risk ofendometrial cancer. |
Who may qualify
- Ages
- 45 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with abnormal bleeding or other conditions associated with increased risk of endometrial cancer.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endometrial Cancer and Endometrial Hyper Plasia
Time frame: 1 to 5 years
Histologically confirmed endometrial cancer or endometrial hyperplasia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Background: PubMed 21150796Armstrong 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.
- Background: PubMed 20683604Dimitraki 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.
- Background: PubMed 18026193Lacey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Wentzensen, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer and Gynecological Cancers, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial Cancer and Endometrial Hyper Plasia (time frame: 1 to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01793545, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.