Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500591
Status:
UNKNOWN
Last Update Posted:
2021-02-25
First Post:
2007-07-10
Brief Title:
Prevalence of Endometrial Abnormalities In Obese Women
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Prevalence of Endometrial Abnormalities In Obese Women
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 surveyquestionnaire 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None