Clinical trial NCT00587886: Estrogen, Diet, Genetics and Endometrial Cancer
Official title: Estrogen, Diet, Genetics and Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Endometrial Cancer
Ovarian Cancer
Corpus Uteri
Endometrium
Keywords: Cancer
Endometrial cancer
Ovarian cancer
Corpus Uteri
Endometrium
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
name: Municipal Institute of Medical Research
name: Department of Health and Human Services
name: Penn State University
First posted: 2008-01-08
Enrollment: 1315
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In collaboration with the New Jersey Department of Health and Senior Services NJDHSS), we will use rapid case ascertainment to identify patients as they are diagnosed.For controls aged 65 and over, we will obtain lists from CMS of a sample of women in the 6 counties. As an alternative way of reaching controls, we will conduct area sampling.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To investigate the role of weight, diet, and individual genetic susceptibility to endometrial cancer
timeFrame: 3 years
Secondary outcomes:
measure: The secondary aim of this study is to obtain epidemiologic data on papillary serous and clear cell histologic types of endometrial cancer.
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mengmeng Du, ScD
role: PRINCIPAL_INVESTIGATOR
References: