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Trial record 7 of 1063 for:    Endometrial Cancer: Clinical Trials
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Risk Factors for Endometrial Cancer in Black Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The City College of New York
DOWNSTATE MED/KINGS CO/BKLYN
Montefiore Hospital
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00514254
First received: August 8, 2007
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  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
 Other: questionnaire administration
Other: study of socioeconomic and demographic variables
Procedure: evaluation of cancer risk factors

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Endometrial Cancer in Black Women

Resource links provided by NLM:

U.S. FDA Resources

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

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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number and percentage of cases and controls approached who sign informed consent [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number and percentage of cases and controls who complete each part of the study (main questionnaire, diet questionnaire, saliva/buccal specimen) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Proportion of questions with missing data [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Interviewer's evaluation of interview quality and respondent cooperation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number and percentage of cases who are willing to have tumor specimens used for future research [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Characteristics of cases and controls (demographics, main risk factors, and use of health care and screening) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Proportion of participants who rate the study positively on each measure in the post-interview assessment and respondents' suggested changes to the study [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

saliva/buccal specimens


Enrollment: 59
Study Start Date: July 2007
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
case
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.
 Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: evaluation of cancer risk factors
control
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.
 Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: evaluation of cancer risk factors

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
Sampling Method:   Non-Probability Sample
Study Population

Black women (including African-American, African, Afro-Caribbean women) with endometrial cancer and controls will be recruited at MSKCC, SUNY Downstate Medical Center and Montefiore Medical Center hospitals. Controls will be black (including African-American, African, Afro-Caribbean) women without history of cancer, who have intact uteri, and will be identified in gynecology clinics. Controls will also be recruited at the Breast Examination Center of Harlem (BECH), an affiliate of MSKCC, providing high quality screening services to a minority community.

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
Montefiore Medical Center
Bronx, New York, United States, 10461
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
City College of New York
New York, New York, United States, 10031
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
The City College of New York
DOWNSTATE MED/KINGS CO/BKLYN
Montefiore Hospital
Investigators
Principal Investigator: Sara Olson, PhD Memorial Sloan-Kettering Cancer Center
  More Information

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

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00514254     History of Changes
Other Study ID Numbers: 07-093, P30CA008748, MSKCC-07093
Study First Received: August 8, 2007
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
endometrial cancer
risk factors
questionnaire
07-093

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial
Uterine Diseases
Genital Diseases, Female
Sarcoma

ClinicalTrials.gov processed this record on May 23, 2013