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Estrogen, Diet, Genetics and Endometrial Cancer

Estrogen, Diet, Genetics and Endometrial Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00587886
Enrollment
1315
Registered
2008-01-08
Start date
2001-09-25
Completion date
2026-12-31
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Corpus Uteri, Endometrial Cancer, Endometrium, Ovarian Cancer

Keywords

Cancer, Endometrial cancer, Ovarian cancer, Corpus Uteri, Endometrium

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.

Interventions

BEHAVIORALQuestionnaire

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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
Rutgers Cancer Institute of New Jersey
CollaboratorOTHER
Municipal Institute of Medical Research
CollaboratorUNKNOWN
Department of Health and Human Services
CollaboratorFED
Penn State University
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
To investigate the role of weight, diet, and individual genetic susceptibility to endometrial cancer3 years

Secondary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMengmeng Du, ScD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026