Estrogen, Diet, Genetics and Endometrial Cancer

Cancer Clinical Trial

Official title:

Estrogen, Diet, Genetics and Endometrial Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00587886
• Other study ID #: 01-119
• Secondary ID: CA83918
• Status: Active, not recruiting
• Start date: September 25, 2001
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1315
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Corpus Uteri
• Endometrial Cancer
• Endometrial Neoplasms
• Endometrium
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (6)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Department of Health and Human Services, Municipal Institute of Medical Research, National Cancer Institute (NCI), Penn State University, Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the role of weight, diet, and individual genetic susceptibility to endometrial cancer		3 years
Secondary	The secondary aim of this study is to obtain epidemiologic data on papillary serous and clear cell histologic types of endometrial cancer.		3 years

External Links

•   Memorial Sloan-Kettering web site