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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

December 24, 2007
January 30, 2014
September 2001
December 2014   (final data collection date for primary outcome measure)
To investigate the role of weight, diet, and individual genetic susceptibility to endometrial cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00587886 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Estrogen, Diet, Genetics and Endometrial Cancer
Estrogen, Diet, Genetics and Endometrial Cancer

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Buccal specimen

Probability Sample

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.

  • Cancer
  • Endometrial Cancer
  • Ovarian Cancer
  • Corpus Uteri
  • Endometrium
  • 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.
  • 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.

  • Cases
    Cases will be women with newly diagnosed endometrial or ovarian cancer who are residents of six counties in New Jersey.
    Intervention: Behavioral: Questionnaire
  • 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.
    Intervention: Behavioral: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1315
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Female
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587886
01-119, CA83918
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey
  • Municipal Institute of Medical Research
  • Department of Health and Human Services
  • Penn State University
Principal Investigator: Sara Olson, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP