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NCT Number: NCT00587886

Estrogen, Diet, Genetics and Endometrial Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

Questionnaire

Behavioral

The main questionnaire will cover established risk and protective factors for endometrial and ovarian cancer, as well as other possible risk factors. This includes: menstrual history; pregnancy history; use of hormones for menopausal symptoms or other reasons; smoking history; height and weight; use of oral contraceptives and other methods of birth control; family history of cancer; medical history; demographic characteristics. We will also collect dietary data using the Gladys Block questionnaire, to which we have added a supplement to measure consumption of phytoestrogens. We will also obtain a buccal sample from each respondent as the source of DNA for genetic analysis.

Primary outcomes

  1. To investigate the role of weight, diet, and individual genetic susceptibility to endometrial cancer

    Time frame: 3 years

Secondary outcomes

  1. The secondary aim of this study is to obtain epidemiologic data on papillary serous and clear cell histologic types of endometrial cancer.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Department of Health and Human Services
  • Municipal Institute of Medical Research
  • National Cancer Institute (NCI)
  • Penn State University
  • Rutgers Cancer Institute of New Jersey

Registry information

Important dates

Study start
2001
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2008
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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