Estrogen, Diet, Genetics and Endometrial Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00587886

Collaborator

National Cancer Institute (NCI) (NIH), Rutgers Cancer Institute of New Jersey (Other), Municipal Institute of Medical Research (Other), Department of Health and Human Services (U.S. Fed), Penn State University (Other)

1,315

Enrollment

Location

267.2

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Endometrial Cancer Ovarian Cancer Corpus Uteri Endometrium	Behavioral: Questionnaire Behavioral: Questionnaire

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 Design

Study Type:

Observational

Actual Enrollment :

1315 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Estrogen, Diet, Genetics and Endometrial Cancer

Actual Study Start Date :

Sep 25, 2001

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cases Cases will be women with newly diagnosed endometrial or ovarian cancer who are residents of six counties in New Jersey.	Behavioral: Questionnaire 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.
Controls 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.	Behavioral: Questionnaire 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. We will conduct interviews mainly by telephone but also in person (at home or another convenient place)if the participant prefers.

Arm

Intervention/Treatment

Cases

Cases will be women with newly diagnosed endometrial or ovarian cancer who are residents of six counties in New Jersey.

Behavioral: Questionnaire

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.

Controls

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.

Behavioral: Questionnaire

Outcome Measures

Primary Outcome Measures

To investigate the role of weight, diet, and individual genetic susceptibility to endometrial cancer [3 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts 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