Risk Factors for Endometrial Cancer in Black Women

August 9, 2023 updated by: Memorial Sloan Kettering Cancer Center

Endometrial Cancer in Black Women

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • Brooklyn, New York, United States, 11203
        • SUNY downstate Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10031
        • City College of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years
Number and percentage of cases and controls approached who sign informed consent
Time Frame: 2 years
2 years
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
2 years
Proportion of questions with missing data
Time Frame: 2 years
2 years
Interviewer's evaluation of interview quality and respondent cooperation
Time Frame: 2 years
2 years
Number and percentage of cases who are willing to have tumor specimens used for future research
Time Frame: 2 years
2 years
Characteristics of cases and controls (demographics, main risk factors, and use of health care and screening)
Time Frame: 2 years
2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

August 8, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (Estimated)

August 9, 2007

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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