Estrogen, Diet, Genetics and Endometrial Cancer

Active, not recruiting

• Conditions: Cancer; Endometrial Cancer; Corpus Uteri; Ovarian Cancer; Endometrium
• Interventions: Behavioral: Questionnaire

• Registration Number: NCT00587886
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to see how people's diets, other aspects of their lifestyles, and their individual genetic makeup affect their chances of getting endometrial cancer (cancer of the uterus).

This survey will enroll several hundred women who have or have had endometrial cancer and several hundred who do not. We will compare these two groups of women to see what factors may lead to endometrial cancer.

Detailed Description

We will conduct a population-based case-control study in six counties of New Jersey. Cases will be women with newly-diagnosed endometrial or ovarian cancer. Controls will be matched by 5-year age groups and selected by random digit dialing (for those under 65), from Centers for Medicare and Medicaid Services (CMS) files (for those 65 and over), or from neighborhood sampling. Controls will not have had a hysterectomy.

There will be 400 cases with endometrioid tumors, 60 with serous tumors or clear cell tumors, 300 with ovarian cancer, and 400 controls. In addition, there will be a small group of black women included from MSKCC.

We will interview participants about known and potential risk factors for endometrial and ovarian cancer and obtain information on diet. We will obtain DNA for genetic analysis from buccal specimens collected using a mouthwash rinse method. We will use logistic regression to determine odds ratios for disease with various exposures. For endometrial cancer, we will examine the association of risk with genotypes in strata defined by body mass index and dietary fat consumption.

Study Timeline

• Study Start: 2001-09-25
• Study First Submitted: 2007-12-24
• Study First Submitted QC: 2007-12-24
• Study First Posted: 2008-01-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1315

Inclusion Criteria

• Diagnosed with epithelial endometrial or ovarian cancer within the year before being contacted (cases)
• Aged 21 and over
• Residents of Essex, Union, Morris, Middlesex, Bergen, or Hudson counties, NJ
• Black women with and without endometrial cancer who are seeing gynecologists at MSKCC

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Exclusion Criteria

• Unable to sign informed consent
• Consent withheld by physician (cases)
• Hysterectomy (controls)
• Do not speak English or Spanish

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Questionnaire	Controls will be selected from the general population in those counties by use of random digit dialing for those under 65 years of age, from Centers for Medicare and Medicaid Services (CMS) lists for those aged 65 years and over, and from neighborhood sampling.
Cases	Questionnaire	Cases will be women with newly diagnosed endometrial or ovarian cancer who are residents of six counties in New Jersey.

Primary Outcome Measures

Name	Time	Method
To investigate the role of weight, diet, and individual genetic susceptibility to endometrial cancer	3 years

Secondary Outcome Measures

Name	Time	Method
The secondary aim of this study is to obtain epidemiologic data on papillary serous and clear cell histologic types of endometrial cancer.	3 years

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States