Estrogen, Diet, Genetics and Endometrial Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Rutgers Cancer Institute of New Jersey
Municipal Institute of Medical Research
Penn State University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00587886
First received: December 24, 2007
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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 Intervention
Cancer
Endometrial Cancer
Ovarian Cancer
Corpus Uteri
Endometrium
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Estrogen, Diet, Genetics and Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To investigate the role of weight, diet, and individual genetic susceptibility to endometrial cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Buccal specimen


Enrollment: 1315
Study Start Date: September 2001
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587886

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Rutgers Cancer Institute of New Jersey
Municipal Institute of Medical Research
Penn State University
Investigators
Principal Investigator: Sara Olson, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00587886     History of Changes
Other Study ID Numbers: 01-119, CA83918
Study First Received: December 24, 2007
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Cancer
Endometrial cancer
Ovarian cancer
Corpus Uteri
Endometrium

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Ovarian Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Endocrine Gland Neoplasms
Genital Diseases, Female
Sarcoma
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014