- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00514254
Risk Factors for Endometrial Cancer in Black Women
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
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Montefiore Medical Center
-
Brooklyn, New York, United States, 11203
- SUNY Downstate Medical Center
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10031
- City College of New York
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Collaborators
Investigators
- Principal Investigator: Sara Olson, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-093
- P30CA008748 (U.S. NIH Grant/Contract)
- MSKCC-07093
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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