Risk Factors for Endometrial Cancer in Black Women

Endometrial Cancer Clinical Trial

Official title:

Endometrial Cancer in Black Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00514254
• Other study ID #: 07-093
• Secondary ID: P30CA008748MSKCC
• Status: Active, not recruiting
• Start date: July 2007
• Est. completion date: July 2025

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Other:
• questionnaire administration

• study of socioeconomic and demographic variables

Procedure:
• evaluation of cancer risk factors

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	City College of New York	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	DOWNSTATE MED/KINGS CO/BKLYN, Montefiore Hospital, National Cancer Institute (NCI), The City College of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		2 years
Primary	Number and percentage of cases and controls approached who sign informed consent		2 years
Primary	Number and percentage of cases and controls who complete each part of the study (main questionnaire, diet questionnaire, saliva/buccal specimen)		2 years
Primary	Proportion of questions with missing data		2 years
Primary	Interviewer's evaluation of interview quality and respondent cooperation		2 years
Primary	Number and percentage of cases who are willing to have tumor specimens used for future research		2 years
Primary	Characteristics of cases and controls (demographics, main risk factors, and use of health care and screening)		2 years
Primary	Proportion of participants who rate the study positively on each measure in the post-interview assessment and respondents' suggested changes to the study		2 years

External Links

•   Memorial Sloan Kettering Cancer Center