ObesityNCT00500591
Prevalence of Endometrial Abnormalities In Obese Women
An observational study of Obesity, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
It is known that women who are obese are at higher risk of endometrial cancer (cancer of the lining of the uterus or womb). The goal of this clinical research study is to find out how common abnormalities of the endometrium are in women who are considered obese and to find out if those same abnormalities are less… Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2021
- 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 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Study participants with a measured BMI greater than or equal to 30 kg/m^2 (obese) or less than or equal to 25 kg/m^2 (lean) at the time of enrollment.
Who may be able to join
- Patients must have a measured BMI greater than or equal to 30 kg/m2 (obese) or less than or equal to 25 kg/m2 (lean) at the time of enrollment.
- Patients must be between the ages of 30 and 55 years old at the time of enrollment.
- Patients must not have taken any birth control (including pills, patch, injectables) for at least three months prior to enrollment.
- Patients may not be pregnant at the time of enrollment (defined by negative urine pregnancy test).
- Patients must have signed an informed consent indicating they are aware of the investigational nature of this study.
- Patients with a history of non-metastatic cancer may be included if they have not undergone cancer treatment for at least six months prior to enrollment.
Who cannot join
- Patients who have had a prior hysterectomy.
- Patients who are pregnant or have a positive pregnancy test.
- Patients with a prior history of endometrial hyperplasia or endometrial cancer.
- Patients who are currently on birth control (including pills, patch, or injectable birth control).
- Patients who are postmenopausal (have not had a menstrual cycle in greater than or equal to one year).
- Patients who have ever been on selective estrogen receptor modulators (SERMs) in the past including Tamoxifen and Raloxifene.
Show all 11Show fewer
- Patients with a history of metastatic cancer (any type).
- Patients with a history of non-metastatic cancer who are currently undergoing therapy for that cancer or who have received therapy within six months of enrollment.
- Patients with a history of non-metastatic cancer who have received any type of hormonal therapy including but not limited to aromatase inhibitors, GNRH-agonists, and Zoladex.
- Patients who have had prior radiation to the pelvis.
- Patients with psychiatric disorders that would interfere with consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
It is known that women who are obese are at higher risk of endometrial cancer (cancer of the lining of the uterus or womb). The goal of this clinical research study is to find out how common abnormalities of the endometrium are in women who are considered obese and to find out if those same abnormalities are less common in women who are considered to be thin. Researchers would like to learn if obese patients have symptoms (like irregular menstrual cycles) that may mean there could be an abnormality present. Researchers would also like to know if obese women have access to regular female exams and whether they routinely go to their primary care doctors.
Read the detailed description
Women in this study will be asked to complete three different parts of the study. All three parts of the study will be done during one visit to the gynecology center. First, you will be asked to complete a survey/questionnaire that will give researchers information on your background, weight history, gynecologic, and medical history. You will be assisted by a research nurse and completion of the questionnaire is expected take about 30 minutes.
Second, you will be asked to have a blood sample drawn. About 2 tablespoons of blood will be drawn. This blood will be used to look at different hormone levels that may be related to your risk of endometrial abnormalities.
Third, an endometrial biopsy will be performed by one of the doctors running the study. This will require you to have a full pelvic exam (much like when you have a pap smear), which will include looking at the cervix (mouth of the womb) and putting a small pipelle (straw) into the womb to collect a tissue sample. This procedure is routinely done in the office. You will not be required to take medications prior to the procedure and you will not receive a prescription for pain medication once the procedure is complete.
Completion of all three parts of the study may take between one to two hours. You and your physician will be notified of your endometrial biopsy results.
This is an investigational study. Up to 200 participants will be enrolled in this study. All will be enrolled at MD Anderson.
- Conditions
- Obesity
- Being tested
- Questionnaire
- Keywords
- Endometrial Abnormalities, Endometrial Cancer, Obesity, Survey, Questionnaire
- Medical subject headings
- Obesity, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaire regarding weight history, gynecologic, and medical history, lasting about 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Obese Women | Not described Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Endometrial Abnormalities in Obese and Lean Women
Measured: 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startJun 2004
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen H. Lu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500591
- Sponsor's protocol ID
- 2004-0018
- Status last verified
- Feb 2021
- First submitted
- 10 Jul 2007
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Dottino JA, Zhang Q, Loose DS, Fellman B, Melendez BD, Borthwick MS, McKenzie LJ, Yuan Y, Yang RK, Broaddus RR, Lu KH, Soliman PT, Yates MS. Endometrial biomarkers in premenopausal women with obesity: an at-risk cohort. Am J Obstet Gynecol. 2021 Mar;224(3):278.e1-278.e14. doi: 10.1016/j.ajog.2020.08.053. Epub 2020 Aug 21.
PubMed 32835719
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Endometrial Abnormalities In Obese Women
- ClinicalTrials.gov ID
- NCT00500591
- Acronym / sponsor ID
- 2004-0018
- Conditions
- Obesity
- Keywords
- Endometrial Abnormalities, Endometrial Cancer, Obesity, Survey, Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2004 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 12 Jul 2007 (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.
It is known that women who are obese are at higher risk of endometrial cancer (cancer of the lining of the uterus or womb). The goal of this clinical research study is to find out how common abnormalities of the endometrium are in women who are considered obese and to find out if those same abnormalities are less common in women who are considered to be thin. Researchers would like to learn if obese patients have symptoms (like irregular menstrual cycles) that may mean there could be an abnormality present. Researchers would also like to know if obese women have access to regular female exams and whether they routinely go to their primary care doctors.
Detailed description
Women in this study will be asked to complete three different parts of the study. All three parts of the study will be done during one visit to the gynecology center. First, you will be asked to complete a survey/questionnaire that will give researchers information on your background, weight history, gynecologic, and medical history. You will be assisted by a research nurse and completion of the questionnaire is expected take about 30 minutes.
Second, you will be asked to have a blood sample drawn. About 2 tablespoons of blood will be drawn. This blood will be used to look at different hormone levels that may be related to your risk of endometrial abnormalities.
Third, an endometrial biopsy will be performed by one of the doctors running the study. This will require you to have a full pelvic exam (much like when you have a pap smear), which will include looking at the cervix (mouth of the womb) and putting a small pipelle (straw) into the womb to collect a tissue sample. This procedure is routinely done in the office. You will not be required to take medications prior to the procedure and you will not receive a prescription for pain medication once the procedure is complete.
Completion of all three parts of the study may take between one to two hours. You and your physician will be notified of your endometrial biopsy results.
This is an investigational study. Up to 200 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese Women | – | Behavioral: Questionnaire |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study participants with a measured BMI greater than or equal to 30 kg/m^2 (obese) or less than or equal to 25 kg/m^2 (lean) at the time of enrollment.
Key inclusion criteria (6 listed)
- Patients must have a measured BMI greater than or equal to 30 kg/m2 (obese) or less than or equal to 25 kg/m2 (lean) at the time of enrollment.
- Patients must be between the ages of 30 and 55 years old at the time of enrollment.
- Patients must not have taken any birth control (including pills, patch, injectables) for at least three months prior to enrollment.
- Patients may not be pregnant at the time of enrollment (defined by negative urine pregnancy test).
- Patients must have signed an informed consent indicating they are aware of the investigational nature of this study.
Key exclusion criteria (11 listed)
- Patients who have had a prior hysterectomy.
- Patients who are pregnant or have a positive pregnancy test.
- Patients with a prior history of endometrial hyperplasia or endometrial cancer.
- Patients who are currently on birth control (including pills, patch, or injectable birth control).
- Patients who are postmenopausal (have not had a menstrual cycle in greater than or equal to one year).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaire regarding weight history, gynecologic, and medical history, lasting about 30 minutes. | Behavioural | Obese Women |
Primary outcome
Prevalence of Endometrial Abnormalities in Obese and Lean Women
Time frame: 6 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 32835719Dottino JA, Zhang Q, Loose DS, Fellman B, Melendez BD, Borthwick MS, McKenzie LJ, Yuan Y, Yang RK, Broaddus RR, Lu KH, Soliman PT, Yates MS. Endometrial biomarkers in premenopausal women with obesity: an at-risk cohort. Am J Obstet Gynecol. 2021 Mar;224(3):278.e1-278.e14. doi: 10.1016/j.ajog.2020.08.053. Epub 2020 Aug 21.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Karen H. Lu, MD principal investigator
M.D. Anderson Cancer Center
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 Obesity, run by M.D. Anderson Cancer Center 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 11 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: status not confirmed, as of the sponsor's last update on 25 Feb 2021. 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?
Results are not available in the source record.
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?
Prevalence of Endometrial Abnormalities in Obese and Lean Women (time frame: 6 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 NCT00500591, which also lists 1 linked publication.
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 25 Feb 2021.