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Estrogen, Diet, Genetics and Endometrial Cancer

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Active, not recruiting

Conditions

Endometrium
Endometrial Cancer
Corpus Uteri
Cancer
Ovarian Cancer

Treatments

Behavioral: Questionnaire

Study type

Observational

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT00587886
CA83918
01-119

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,315 patients

Sex

Female

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

1,315 participants in 2 patient groups

Cases
Description:
Cases will be women with newly diagnosed endometrial or ovarian cancer who are residents of six counties in New Jersey.
Treatment:
Behavioral: Questionnaire
Behavioral: Questionnaire
Controls
Description:
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.
Treatment:
Behavioral: Questionnaire
Behavioral: Questionnaire

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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