Endometrial Cancer
Conditions
Brief summary
The purpose of this study is to develop an endometrial biopsy screening program for endometrial cancer and its precursor lesions in overweight and obese women. There is a BMI threshold at and above which optimal screening parameters exist for identifying endometrial cancer and its precursor lesions in overweight and/or obese women. Prevention, diagnosis and treatment of endometrial cancer and its precursor lesions in overweight and/or obese women offers substantial health benefits.
Interventions
PROCEDUREEndometrial Biopsy
Recruits from the Bariatric Surgery Program will be interviewed by a study investigator prior to their bariatric surgery. During the interview, the purpose of the study will be explained as well as the surgical technique used for obtaining an endometrial sample. If the patient consents to the procedure, then this will usually be a D&C performed in one setting at the time of her bariatric surgery under general anesthesia. In the case where a patient is diagnosed with complex atypical endometrial hyperplasia or early endometrial prior to her bariatric surgery, an IUD can be inserted at the time of her bariatric surgery. For patients not undergoing bariatric surgery, an endometrial biopsy will be performed in the clinic or office setting using an endometrial suction catheter.
Sponsors
St. Luke's-Roosevelt Hospital Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Have BMI ≥25. * Be patients of the St. Luke's and Roosevelt Gynecology Clinics and Faculty Practices OR be receiving bariatric surgery. * Complete a full medical history, a detailed menstrual and/or postmenopausal bleeding history, and endometrial biopsy. * Have a negative pregnancy test, if of childbearing age. * Be at least 18 years of age. * Have signed a written Informed Consent Document. * Be willing and able to comply with the study requirements.
Exclusion criteria
* Have a BMI \<25. * Have a prior hysterectomy. * Be pregnant or have a positive pregnancy test * Have untreated vaginal, cervical, or adnexal infection. * Recent treatment of STD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A BMI cut-point will be identified at and above which an endometrial biopsy yields optimal sensitivity, specificity, positive predictive value, and negative predictive value to screen for endometrial cancer and abnormal pathologies | up to 1 year |
Countries
United States
Outcome results
None listed