Overview

This trial is active, not recruiting.

Conditions cancer, endometrial cancer, ovarian cancer, corpus uteri, endometrium
Treatments questionnaire
Sponsor Memorial Sloan-Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date September 2001
End date December 2015
Trial size 1315 participants
Trial identifier NCT00587886, 01-119, CA83918

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Cases will be women with newly diagnosed endometrial or ovarian cancer who are residents of six counties in New Jersey.
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 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.
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.

Primary Outcomes

Measure
To investigate the role of weight, diet, and individual genetic susceptibility to endometrial cancer
time frame: 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.
time frame: 3 years

Eligibility Criteria

Female participants at least 21 years old.

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

Additional Information

Official title Estrogen, Diet, Genetics and Endometrial Cancer
Principal investigator Sara Olson, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan-Kettering Cancer Center.