NCT00587886

Brief Summary

The purpose of this study is to see how people's diets, other aspects of their lifestyles, and their individual genetic makeup affect their chances of getting endometrial cancer (cancer of the uterus). This survey will enroll several hundred women who have or have had endometrial cancer and several hundred who do not. We will compare these two groups of women to see what factors may lead to endometrial cancer.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,315

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Sep 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Progress97%
Sep 2001Dec 2026

Study Start

First participant enrolled

September 25, 2001

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
19 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

25.3 years

First QC Date

December 24, 2007

Last Update Submit

March 23, 2026

Conditions

CancerEndometrial CancerOvarian CancerCorpus UteriEndometrium

Keywords

CancerEndometrial cancerOvarian cancerCorpus UteriEndometrium

Outcome Measures

Primary Outcomes (1)

  • To investigate the role of weight, diet, and individual genetic susceptibility to endometrial cancer

    3 years

Secondary Outcomes (1)

  • The secondary aim of this study is to obtain epidemiologic data on papillary serous and clear cell histologic types of endometrial cancer.

    3 years

Study Arms (2)

Cases

Cases will be women with newly diagnosed endometrial or ovarian cancer who are residents of six counties in New Jersey.

Behavioral: Questionnaire

Controls

Controls will be selected from the general population in those counties by use of random digit dialing for those under 65 years of age, from Centers for Medicare and Medicaid Services (CMS) lists for those aged 65 years and over, and from neighborhood sampling.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

The main questionnaire will cover established risk and protective factors for endometrial and ovarian cancer, as well as other possible risk factors. This includes: menstrual history; pregnancy history; use of hormones for menopausal symptoms or other reasons; smoking history; height and weight; use of oral contraceptives and other methods of birth control; family history of cancer; medical history; demographic characteristics. We will also collect dietary data using the Gladys Block questionnaire, to which we have added a supplement to measure consumption of phytoestrogens. We will also obtain a buccal sample from each respondent as the source of DNA for genetic analysis.

Cases

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In collaboration with the New Jersey Department of Health and Senior Services NJDHSS), we will use rapid case ascertainment to identify patients as they are diagnosed.For controls aged 65 and over, we will obtain lists from CMS of a sample of women in the 6 counties. As an alternative way of reaching controls, we will conduct area sampling.

You may qualify if:

  • Diagnosed with epithelial endometrial or ovarian cancer within the year before being contacted (cases)
  • Aged 21 and over
  • Residents of Essex, Union, Morris, Middlesex, Bergen, or Hudson counties, NJ
  • Black women with and without endometrial cancer who are seeing gynecologists at MSKCC

You may not qualify if:

  • Unable to sign informed consent
  • Consent withheld by physician (cases)
  • Hysterectomy (controls)
  • Do not speak English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Buccal specimen

MeSH Terms

Conditions

NeoplasmsEndometrial NeoplasmsOvarian Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Mengmeng Du, ScD

    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

December 24, 2007

First Posted

January 8, 2008

Study Start

September 25, 2001

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(1)