**Estrogen, Diet, Genetics and Endometrial Cancer**\
\
This study is currently recruiting participants.\
Verified by Memorial Sloan-Kettering Cancer Center, June 2008

  ----------------------------------------------------------------------------------------------------------------------------------------------------------
  Sponsors and Collaborators:      **Memorial Sloan-Kettering Cancer Center**\
                                   [[National Cancer Institute (NCI)]{.underline}](http://clinicaltrials.gov/ct2/bye/7QoPWw4lZX-i-iSxuBc5udNzlXNiZiJ.)\
                                   Cancer Institute of New Jersey\
                                   Municipal Institute of Medical Research\
                                   [[Department of Health and Human Services]{.underline}](http://clinicaltrials.gov/ct2/bye/CQoPWw4lZX-i-iSxlQoRu6c9cXE.)
  -------------------------------- -------------------------------------------------------------------------------------------------------------------------
  Information provided by:         Memorial Sloan-Kettering Cancer Center

  ClinicalTrials.gov Identifier:   NCT00587886
  ----------------------------------------------------------------------------------------------------------------------------------------------------------

![http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif](media/image1.gif){width="0.16666666666666666in"
height="0.15625in"}  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]{.underline}](http://clinicaltrials.gov/ct2/help/conditions_desc)   [[Intervention]{.underline}](http://clinicaltrials.gov/ct2/help/interventions_desc)
  ------------------------------------------------------------------------------- -------------------------------------------------------------------------------------
  Cancer\                                                                         Behavioral: Questionnaire
  Endometrial Cancer\                                                             
  Ovarian Cancer\                                                                 
  Corpus Uteri\                                                                   
  Endometrium                                                                     

  ---------------------------------------------------------------------------------------------------------------------------------------------------------------------

  ------------------------------------------------------------------------------------ --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  [[Genetics Home Reference]{.underline}](http://ghr.nlm.nih.gov/) related topics:     [[Benign Tumors]{.underline}](http://clinicaltrials.gov/ct2/bye/SQoPWw4lZXcilwpxudhWudNzlXNiZip90dcx5Q1PedcxowN9Lw4Lp67xe6cxWi7LZwUR.)   [[Cancer]{.underline}](http://clinicaltrials.gov/ct2/bye/vQoPWw4lZXcilwpxudhWudNzlXNiZip90dcx5Q1PedcxowN9Lw4L0B7x061n.)   [[Uterine Fibroids]{.underline}](http://clinicaltrials.gov/ct2/bye/LQoPWw4lZXcilwpxudhWudNzlXNiZip90dcx5Q1PedcxowN9Lw4LLihHSQ7xz6NzpwN9e6oR.)  
  ------------------------------------------------------------------------------------ --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

  ------------------------------------------------------------------------------------ ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  [[MedlinePlus]{.underline}](http://www.nlm.nih.gov/medlineplus/) related topics:     [[Cancer]{.underline}](http://clinicaltrials.gov/ct2/bye/uQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS90B7x061nuQoPmdt.)   [[Ovarian Cancer]{.underline}](http://clinicaltrials.gov/ct2/bye/LQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS9ZiNGSQ7GuBcGuBcHSXNkWd7E.)  
  ------------------------------------------------------------------------------------ ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[U.S. FDA
Resources]{.underline}](http://clinicaltrials.gov/ct2/info/fdalinks)

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

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

Biospecimen Description:

Buccal specimen

  Estimated Enrollment:                  1400
  -------------------------------------- ------------------------------------------------------------------------
  Study Start Date:                      September 2001
  Estimated Study Completion Date:       December 2009
  Estimated Primary Completion Date:     December 2009 (Final data collection date for primary outcome measure)

+----------------------------------+----------------------------------+
| [[Groups/Cohorts]                | [[Assigned                       |
| {.underline}](http://clinicaltri | Interventions]{.un               |
| als.gov/ct2/help/arm_group_desc) | derline}](http://clinicaltrials. |
|                                  | gov/ct2/help/interventions_desc) |
+==================================+==================================+
| Cases                            | Behavioral: Questionnaire        |
|                                  |                                  |
| Cases will be women with newly   | The main questionnaire will      |
| diagnosed endometrial or ovarian | cover established risk and       |
| cancer who are residents of six  | protective factors for           |
| counties in New Jersey.          | 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                         | Behavioral: Questionnaire        |
|                                  |                                  |
| Controls will be selected from   | The main questionnaire will      |
| the general population in those  | cover established risk and       |
| counties by use of random digit  | protective factors for           |
| dialing for those under 65 years | endometrial and ovarian cancer,  |
| of age, from Centers for         | as well as other possible risk   |
| Medicare and Medicaid Services   | factors. This includes:          |
| (CMS) lists for those aged 65    | menstrual history; pregnancy     |
| years and over, and from         | history; use of hormones for     |
| neighborhood sampling.           | 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.

![http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif](media/image1.gif){width="0.16666666666666666in"
height="0.15625in"}  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

![http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif](media/image1.gif){width="0.16666666666666666in"
height="0.15625in"}  Contacts and Locations

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

  ------------------------------ -- -------------------------------------------------------------------------------------------------------------------------------------------------------------
  Contact: Sara Olson, PhD          [[olsons\@mskcc.org]{.underline}](mailto:olsons%40mskcc.org?subject=NCT00587886,%2001-119,%20Estrogen,%20Diet,%20Genetics%20and%20Endometrial%20Cancer)    
  ------------------------------ -- -------------------------------------------------------------------------------------------------------------------------------------------------------------

\
Locations

  ------------------------- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- -- ------------
  United States, New York                                                                                                                                                                                                           
                            Memorial Sloan-Kettering Cancer Center                                                                                                                                                                  Recruiting
                                  New York, New York, United States, 10065                                                                                                                                                          
                                  Contact: Sara Olson, PhD         [[olsons\@mskcc.org]{.underline}](mailto:olsons%40mskcc.org?subject=NCT00587886,%2001-119,%20Estrogen,%20Diet,%20Genetics%20and%20Endometrial%20Cancer)          
  ------------------------- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- -- ------------

Sponsors and Collaborators

  -------------------------------------------------------------------------------------------------------------------------
  **Memorial Sloan-Kettering Cancer Center**
  [[National Cancer Institute (NCI)]{.underline}](http://clinicaltrials.gov/ct2/bye/7QoPWw4lZX-i-iSxuBc5udNzlXNiZiJ.)
  Cancer Institute of New Jersey
  Municipal Institute of Medical Research
  [[Department of Health and Human Services]{.underline}](http://clinicaltrials.gov/ct2/bye/CQoPWw4lZX-i-iSxlQoRu6c9cXE.)
  -------------------------------------------------------------------------------------------------------------------------

Investigators

  ----------------------------- --------------------- --------------------------------------------
  Principal Investigator:       Sara Olson, PhD       Memorial Sloan-Kettering Cancer Center    
  ----------------------------- --------------------- --------------------------------------------

![http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif](media/image1.gif){width="0.16666666666666666in"
height="0.15625in"}  More Information

  -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  [[Memorial Sloan-Kettering web site]{.underline}](http://clinicaltrials.gov/ct2/bye/8QoPWw4lZX-i-iSxmwcm0BSxZwNw/kC7Hmd-yeB7EJ8caZB7OmDcHWihHSQ7xUnoizBp3FQ1Pz)  ![This link exits the ClinicalTrials.gov site](media/image2.png){width="0.1875in" height="0.10416666666666667in"}\
   

  -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

  Responsible Party:                 Memorial Sloan-Kettering Cancer Center ( Sara Olson, PhD )
  ---------------------------------- -----------------------------------------------------------------------------
  Study ID Numbers:                  01-119, CA83918
  First Received:                    December 24, 2007
  Last Updated:                      June 2, 2008
  ClinicalTrials.gov Identifier:     [[NCT00587886]{.underline}](http://clinicaltrials.gov/ct2/show/NCT00587886)
  Health Authority:                  United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

+--------------------------+
|   Cancer                 |
|   ---------------------- |
|   Endometrial cancer     |
|   Ovarian cancer         |
|   Corpus Uteri           |
|   Endometrium            |
+--------------------------+

Study placed in the following topic categories:

+-------------------------------+---+-------------------------------+
|   Ovarian cancer              |   |   Ovarian Diseases            |
|   --------------------------- |   |   --------------------------- |
|   Ovarian Neoplasms           |   |   Genital Diseases, Female    |
|   Gonadal Disorders           |   |   Endometrial Neoplasms       |
|   Genital Neoplasms, Female   |   |   Uterine Neoplasms           |
|   Endocrine System Diseases   |   |   Endocrinopathy              |
|   Uterine Diseases            |   |   Endometrial cancer          |
|   Urogenital Neoplasms        |   |   Endocrine Gland Neoplasms   |
+-------------------------------+---+-------------------------------+

Additional relevant MeSH terms:

+-----------------------+
|   Neoplasms           |
|   ------------------- |
|   Neoplasms by Site   |
|   Adnexal Diseases    |
+-----------------------+

ClinicalTrials.gov processed this record on July 09, 2008