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Risk Factors for Endometrial Cancer in Black Women
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00514254
  Purpose

RATIONALE: Learning about the risk factors for endometrial cancer in black women may help the study of endometrial cancer in the future.

PURPOSE: This clinical trial is studying risk factors for endometrial cancer in black women.


Condition Intervention
Endometrial Cancer
Procedure: evaluation of cancer risk factors
Procedure: questionnaire administration
Procedure: study of socioeconomic and demographic variables

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: Endometrial Cancer in Black Women

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Number and percentage of potential cases and controls approached who are found to be eligible for the study and reasons for being ineligible (including language)
  • Number and percentage of cases and controls approached who sign informed consent
  • Number and percentage of cases and controls who complete each part of the study (main questionnaire, diet questionnaire, saliva/buccal specimen)
  • Proportion of questions with missing data
  • Interviewer's evaluation of interview quality and respondent cooperation
  • Number and percentage of cases who are willing to have tumor specimens used for future research
  • Characteristics of cases and controls (demographics, main risk factors, and use of health care and screening)
  • Proportion of participants who rate the study positively on each measure in the post-interview assessment and respondents' suggested changes to the study

Estimated Enrollment: 60
Study Start Date: July 2007
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Establish and evaluate procedures for conducting a hospital-based case-control study of risk factors for endometrial cancer in black women.

OUTLINE: This is a multicenter study.

Participants complete questionnaires about lifestyle factors and their usual diet and measure their waist and hips. Saliva or buccal specimens are collected for future research.

PROJECTED ACCRUAL:

  • A total of 30 cases and 30 controls will be accrued for this study.
  Eligibility

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

DISEASE CHARACTERISTICS:

  • Cases

    • Diagnosed with endometrial cancer within the past year
    • Self-identified as being black, African-American, black Hispanic, African, or Afro-Caribbean
  • Healthy controls

    • Self-identified as being black, African-American, black Hispanic, African, or Afro-Caribbean
    • No history of endometrial or other cancer (except non-melanoma skin cancer)
    • No prior hysterectomy

PATIENT CHARACTERISTICS:

  • Speak English
  • No medical condition that would make it difficult to complete the interview

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514254

Locations
United States, New York
City College of New York Recruiting
New York, New York, United States, 10031
Contact: Tiffany Floyd, MD     212-650-5438        
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Sara Olson, PhD     646-735-8158        
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Mark H. Einstein, MD, MS     718-405-8082        
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Yi-Chun Lee, MD     718-270-2365        
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Sara Olson, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000560388, MSKCC-07093
Study First Received: August 8, 2007
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00514254  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
endometrial cancer

Study placed in the following topic categories:
Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Endometrial cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009