Clinical trial NCT00514254: Risk Factors for Endometrial Cancer in Black Women
Official title: Endometrial Cancer in Black Women
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometrial Cancer
Keywords: endometrial cancer
risk factors
questionnaire
07-093
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: The City College of New York
name: DOWNSTATE MED/KINGS CO/BKLYN
name: Montefiore Medical Center
First posted: 2007-08-09
Enrollment: 59
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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

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)
timeFrame: 2 years
measure: Number and percentage of cases and controls approached who sign informed consent
timeFrame: 2 years
measure: Number and percentage of cases and controls who complete each part of the study (main questionnaire, diet questionnaire, saliva/buccal specimen)
timeFrame: 2 years
measure: Proportion of questions with missing data
timeFrame: 2 years
measure: Interviewer's evaluation of interview quality and respondent cooperation
timeFrame: 2 years
measure: Number and percentage of cases who are willing to have tumor specimens used for future research
timeFrame: 2 years
measure: Characteristics of cases and controls (demographics, main risk factors, and use of health care and screening)
timeFrame: 2 years
measure: Proportion of participants who rate the study positively on each measure in the post-interview assessment and respondents' suggested changes to the study
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: New York
country: United States
facility: City College of New York
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Sara Olson, PhD
role: PRINCIPAL_INVESTIGATOR
References: