Brief Summary

The goal of this clinical research study is to find out if there is a link between insulin resistance (or pre-diabetes) and endometrial cancer. Primary Objective: 1\. To determine the association between insulin resistance and endometrial cancer in women in Harris County, Texas. 2. To assess the effect of body mass index (BMI) on the association between insulin resistance and endometrial cancer. Secondary Objectives:

1.To explore the association between polycystic ovarian syndrome (PCOS) and endometrial cancer.
2.To assess the relationship between known reproductive risk factors, menstrual risk factors, family history and endometrial cancer.
3.To explore the molecular changes associated with insulin resistance and PCOS on normal endometrium and tumor tissue.

Trial Health

On Track

Trial Health Score

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

Enrollment

147

participants targeted

Target at P50-P75 for all trials

Geographic Reach

1 country

8 active sites

Status

completed

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 Start

First participant enrolled

October 1, 2005

Completed

1.8 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2007

Completed

6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed

Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

8.6 years

First QC Date

July 2, 2007

Last Update Submit

May 20, 2014

Conditions

Endometrial Cancer

Keywords

Endometrial CancerPolycystic Ovarian SyndromeInsulin ResistancePre-diabetesHarris CountyPCOSUterusQuestionnaireBody mass indexBMI

Outcome Measures

Primary Outcomes (1)

Prevalence Rate of Insulin Resistance
5 Years

Study Arms (2)

Endometrial Cancer Group

Participants who have had endometrial cancer (cases).

Behavioral: Questionnaire

Control Group

Participants who have not had endometrial cancer (controls).

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaire taking about 20 minutes to complete.

Also known as: Survey

Control GroupEndometrial Cancer Group

Eligibility Criteria

Sexfemale

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Participants from Harris County who have had endometrial cancer (cases) and those who have not (controls).

You may qualify if:

Women with histologically confirmed primary endometrial cancer, who will consent to be enrolled in the study no later than 12 weeks after their primary treatment. All stages, grades and histologic subtypes will be eligible.
Women who reside in Harris County, Texas. (Cases)
Patients must sign an informed consent for the study. (Cases)
Women must speak and understand English or Spanish. (Cases)
Women who reside in Harris County, Texas. (Controls)
No history of prior malignancy with the exception of non-melanoma skin cancer. (Controls)
Intact uterus. (Controls)
Patients must sign an informed consent for the study. (Controls)
Women must speak and understand English or Spanish. (Controls)

You may not qualify if:

Women who reside outside of Harris County, Texas. (Cases)
Patients unwilling or unable to provide informed consent. (Cases)
Metastatic cancer to the endometrium from a different primary. (Cases)
Women who do not speak and understand English or Spanish. (Cases)
Women who reside outside of Harris County, Texas. (Controls)
Previous hysterectomy. (Controls)
History of prior malignancy with the exception of non-melanoma skin cancer. (Controls)
Patients unwilling or unable to provide informed consent. (Controls)
Women who do not speak and understand English or Spanish. (Controls)

Contact the study team to confirm eligibility.