Prevalence of Endometrial Abnormalities In Obese Women

NCT00500591 | Unknown

• 1 other identifier: 2004-0018
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Endometrial Abnormalities; Endometrial Cancer; Obesity; Survey; Questionnaire

Outcome Measures

Primary Outcomes (1)

• Prevalence of Endometrial Abnormalities in Obese and Lean Women

  6 Years

Study Arms (1)

Obese Women

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Questionnaire regarding weight history, gynecologic, and medical history, lasting about 30 minutes.

Also known as: Survey

Obese Women

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 32835719 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples used to look at different hormone levels related to risk of endometrial abnormalities. An endometrial biopsy will be performed to collect a tissue sample.

MeSH Terms

Conditions

Obesity; Endometrial Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Karen H. Lu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 12, 2007
• Study Start: June 1, 2004
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

US (1)