Overview

This trial is active, not recruiting.

Condition endometrial cancer
Treatments questionnaire administration, study of socioeconomic and demographic variables, evaluation of cancer risk factors
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date July 2007
End date July 2017
Trial size 59 participants
Trial identifier NCT00514254, 07-093, MSKCC-07093, P30CA008748

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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.
questionnaire administration
study of socioeconomic and demographic variables
evaluation of cancer risk factors
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.
questionnaire administration
study of socioeconomic and demographic variables
evaluation of cancer risk factors

Primary Outcomes

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

Eligibility Criteria

Female participants at least 21 years old.

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

Additional Information

Official title Endometrial Cancer in Black Women
Principal investigator Sara Olson, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.