Clinical trial · Observational
Prevalence of Endometrial Abnormalities In Obese Women
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Obese Women
- interventionNames
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Prevalence of Endometrial Abnormalities in Obese and Lean Women
- timeFrame
- 6 Years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Patients must be between the ages of 30 and 55 years old at the time of enrollment. 3. Patients must not have taken any birth control (including pills, patch, injectables) for at least three months prior to enrollment. 4. Patients may not be pregnant at the time of enrollment (defined by negative urine pregnancy test). 5. Patients must have signed an informed consent indicating they are aware of the investigational nature of this study. 6. 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. Exclusion Criteria: 1. Patients who have had a prior hysterectomy. 2. Patients who are pregnant or have a positive pregnancy test. 3. Patients with a prior history of endometrial hyperplasia or endometrial cancer. 4. Patients who are currently on birth control (including pills, patch, or injectable birth control). 5. Patients who are postmenopausal (have not had a menstrual cycle in greater than or equal to one year). 6. Patients who have ever been on selective estrogen receptor modulators (SERMs) in the past including Tamoxifen and Raloxifene. 7. Patients with a history of metastatic cancer (any type). 8. 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. 9. 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. 10. Patients who have had prior radiation to the pelvis. 11. Patients with psychiatric disorders that would interfere with consent.
References
Publications (1)
- DERIVEDDottino 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. PMID 32835719