Endometrial CancerNCT00495235
Study of Insulin Resistance and Endometrial Cancer in Harris County, Texas
An observational study of Endometrial Cancer, run by M.D. Anderson Cancer Center at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 147 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2005to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants from Harris County who have had endometrial cancer (cases) and those who have not (controls).
Who may be able to join
- 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)
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- Intact uterus. (Controls)
- Patients must sign an informed consent for the study. (Controls)
- Women must speak and understand English or Spanish. (Controls)
Who cannot join
- 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)
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- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Baylor College of Medicine/Clinics
Houston, Texas, 77030
Ben Taub Hospital
Houston, Texas, 77030
Gynecologic Oncology of Houston
Houston, Texas, 77030
Lyndon B. Johnson General Hospital
Houston, Texas, 77030
St. Luke's Episcopal Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
The Woman's Hospital of Texas
Houston, Texas, 77030
UT MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Case-Control Study of Insulin Resistance and Endometrial Cancer in Harris County, Texas
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:
Read more
- 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:
- To explore the association between polycystic ovarian syndrome (PCOS) and endometrial cancer.
- To assess the relationship between known reproductive risk factors, menstrual risk factors, family history and endometrial cancer.
- To explore the molecular changes associated with insulin resistance and PCOS on normal endometrium and tumor tissue.
Read the detailed description
This study will be comparing women who have had endometrial cancer (cases) to women who have not had endometrial cancer (controls) in Harris County, Texas to better understand the risk factors for getting endometrial cancer. Insulin resistance is a condition of pre-diabetes. Polycystic ovarian syndrome (PCOS) is a condition associated with irregular periods, obesity, infertility, and/or difficulty in getting pregnant. Both insulin resistance and PCOS are believed to increase a woman's risk of getting endometrial cancer.
As part of this study, you will be asked to fill out a questionnaire that asks about your medical history, weight history, family history, reproductive history, and birth control/hormone use. The questionnaire should take about 20 minutes to complete, and you will need to complete it only once. You will have your height and weight measured, and about 4 teaspoons of blood will be drawn to test for insulin resistance (or pre-diabetes). You will be required to fast, not eat or drink anything except water, for 8 hours before having this blood sample drawn. If you are premenopausal and still have both your ovaries, you will have an additional 4 teaspoons of blood drawn to test for PCOS. You will complete the questionnaire during your first visit or at home and will bring it back with you when you come back for your fasting blood test appointment.
If you have been diagnosed with endometrial cancer and have had surgery to remove your uterus, you will also be asked to give permission to use a piece of your leftover tumor and surrounding normal tissue to test for markers of insulin resistance and PCOS. This will be from tissue that was removed during your surgery and will not require another biopsy or surgery.
You will not be required to come back for any follow-up as part of this study. However, you will be asked to fill out a form that asks if you would be willing to be called in the future to participate in other studies.
This is an investigational study. A total of 700 women will take part in this multicenter study, 350 women with endometrial cancer and 350 women without endometrial cancer. A total of up to 350 women will be enrolled at M.D. Anderson.
- Conditions
- Endometrial Cancer
- Being tested
- Questionnaire
- Keywords
- Endometrial Cancer, Polycystic Ovarian Syndrome, Insulin Resistance, Pre-diabetes, Harris County, PCOS, Uterus, Questionnaire, Body mass index, BMI
- Medical subject headings
- Endometrial Neoplasms, Polycystic Ovary Syndrome, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaire taking about 20 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Endometrial Cancer Group | Participants who have had endometrial cancer (cases). Receives: Behavioral: Questionnaire | |
| Control Group | Participants who have not had endometrial cancer (controls). Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence Rate of Insulin Resistance
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startOct 2005
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen H. Lu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495235
- Sponsor's protocol ID
- 2005-0164
- Status last verified
- May 2014
- First submitted
- 2 Jul 2007
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-Control Study of Insulin Resistance and Endometrial Cancer in Harris County, Texas
- ClinicalTrials.gov ID
- NCT00495235
- Acronym / sponsor ID
- 2005-0164
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, Polycystic Ovarian Syndrome, Insulin Resistance, Pre-diabetes, Harris County, PCOS, Uterus, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- May 2014 (actual)
- First posted
- 3 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- To explore the association between polycystic ovarian syndrome (PCOS) and endometrial cancer.
- To assess the relationship between known reproductive risk factors, menstrual risk factors, family history and endometrial cancer.
- To explore the molecular changes associated with insulin resistance and PCOS on normal endometrium and tumor tissue.
Detailed description
This study will be comparing women who have had endometrial cancer (cases) to women who have not had endometrial cancer (controls) in Harris County, Texas to better understand the risk factors for getting endometrial cancer. Insulin resistance is a condition of pre-diabetes. Polycystic ovarian syndrome (PCOS) is a condition associated with irregular periods, obesity, infertility, and/or difficulty in getting pregnant. Both insulin resistance and PCOS are believed to increase a woman's risk of getting endometrial cancer.
As part of this study, you will be asked to fill out a questionnaire that asks about your medical history, weight history, family history, reproductive history, and birth control/hormone use. The questionnaire should take about 20 minutes to complete, and you will need to complete it only once. You will have your height and weight measured, and about 4 teaspoons of blood will be drawn to test for insulin resistance (or pre-diabetes). You will be required to fast, not eat or drink anything except water, for 8 hours before having this blood sample drawn. If you are premenopausal and still have both your ovaries, you will have an additional 4 teaspoons of blood drawn to test for PCOS. You will complete the questionnaire during your first visit or at home and will bring it back with you when you come back for your fasting blood test appointment.
If you have been diagnosed with endometrial cancer and have had surgery to remove your uterus, you will also be asked to give permission to use a piece of your leftover tumor and surrounding normal tissue to test for markers of insulin resistance and PCOS. This will be from tissue that was removed during your surgery and will not require another biopsy or surgery.
You will not be required to come back for any follow-up as part of this study. However, you will be asked to fill out a form that asks if you would be willing to be called in the future to participate in other studies.
This is an investigational study. A total of 700 women will take part in this multicenter study, 350 women with endometrial cancer and 350 women without endometrial cancer. A total of up to 350 women will be enrolled at M.D. Anderson.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrial Cancer Group | – | Behavioral: QuestionnaireParticipants who have had endometrial cancer (cases). |
| Control Group | – | Behavioral: QuestionnaireParticipants who have not had endometrial cancer (controls). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants from Harris County who have had endometrial cancer (cases) and those who have not (controls).
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaire taking about 20 minutes to complete. | Behavioural | Control Group, Endometrial Cancer Group |
Primary outcome
Prevalence Rate of Insulin Resistance
Time frame: 5 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
- MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen H. Lu, MD principal investigator
M.D. Anderson Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by M.D. Anderson Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence Rate of Insulin Resistance (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014.