NCT00514254

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jul 2007

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jul 2007Jul 2026

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
18.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

19 years

First QC Date

August 8, 2007

Last Update Submit

August 11, 2025

Conditions

Keywords

endometrial cancerrisk factorsquestionnaire07-093

Outcome Measures

Primary Outcomes (8)

  • 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

  • Number and percentage of cases and controls approached who sign informed consent

    2 years

  • Number and percentage of cases and controls who complete each part of the study (main questionnaire, diet questionnaire, saliva/buccal specimen)

    2 years

  • Proportion of questions with missing data

    2 years

  • Interviewer's evaluation of interview quality and respondent cooperation

    2 years

  • Number and percentage of cases who are willing to have tumor specimens used for future research

    2 years

  • Characteristics of cases and controls (demographics, main risk factors, and use of health care and screening)

    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

    2 years

Study Arms (2)

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.

Other: questionnaire administrationOther: study of socioeconomic and demographic variablesProcedure: evaluation of cancer risk factors

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.

Other: questionnaire administrationOther: study of socioeconomic and demographic variablesProcedure: evaluation of cancer risk factors

Interventions

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

City College of New York

New York, New York, 10031, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

saliva/buccal specimens

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Sara Olson, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 9, 2007

Study Start

July 1, 2007

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations