Endometrial CancerNCT00375804
Racial Disparity in Endometrial Cancer
An observational study of Endometrial Cancer, run by University of Louisville at 1 site in United States.
Trial summary
The objectives for this study: 1. Investigate some of the causes for the racial disparity of endometrial cancer survival rates among black and white women 2. Examine the biologic correlates of aggressive behavior such as estrogen receptor status, p53 and HER-2/neu overexpression, and aromatase activity Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jun 2010
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chart review of subjects diagnosed with endometrial cancer
Who may be able to join
- Patients diagnosed with a new case of endometrial carcinoma at the University of Louisville Hospital or in the Norton Healthcare system from 1995-2000
Who cannot join
- Patients who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: Racial Disparity in Prevalence and Survival Rates in Endometrial Cancer
The objectives for this study:
- Investigate some of the causes for the racial disparity of endometrial cancer survival rates among black and white women
- Examine the biologic correlates of aggressive behavior such as estrogen receptor status, p53 and HER-2/neu overexpression, and aromatase activity
Read the detailed description
Endometrial cancer is the fourth most common cancer among women and the most common gynecologic cancer. Although the incidence of well-differentiated early stage endometrial cancer is higher among white women, there appears to be an increased incidence of aggressive variants with increased mortality rate among blacks.
Reported 5-year survival rate for white women with endometrial cancer is 90% while black women have only 60% survival. (1,2) Black women tend to have more aggressive cancers and more adverse symptoms such as non-endometrioid histology, grade 3 differentiation, and more stage III and IV cancers. (3,7) Many studies have identified and established risk factors and beneficial behaviors for endometrial cancer, most of which are modifiable. Some of the major risks include obesity, hypertension, high fat diet, diabetes, smoking, increased age, hormone replacement therapy, and tamoxifen use. Behaviors associated with decreased risks are use of oral contraceptives, breast feeding, and physical activity. (4)
There is also evidence that biologic factors may contribute to development of malignant endometrial neoplasms. Both mutation and over expression of the p53 tumor suppressor gene is seen in patients with endometrial cancer, especially those in the advanced stages.
Normally, increased levels of p53 are present in cells with damaged DNA. p53 triggers cells to produce more p21, a molecule that binds to cyclin-dependent kinase 2 (Cdk2). In the unbound state, Cdk2 allows cells to progress to the synthesis stage of the cell cycle; therefore, it remains arrested the Gı phase when it is coupled to p21 in an effort to prevent proliferation of abnormal cells. In addition to this mechanism, p53 is thought to be involved in induction of apoptosis. There are indications that black women may exhibit increased incidence of p53 over expression when compared to white women. (5,6,8)
Another biologic factor involved in endometrial cancer is the estrogen receptor. In contrast to p53, presence of estrogen receptors are a positive prognostic factor because they provide a potential avenue for treating endometrial carcinomas. However, the receptors must be functional in order to be advantageous. Some tumors contain mutated estrogen receptors, which cause changes in the metabolic pathway. Individuals with mutated receptors have varying susceptibilities to developing endometrial cancer. (9)
Aromatase is an enzyme involved in converting androgens to estrogens. Both estrogen and aromatase excess has been identified in endometrial cancer, while no aromatase activity has been indicated in the normal endometrium. Most of the aromatase activity appears to be confined to the stromal cells and is correlated with stromal invasion. It may be possible to inhibit aromatase in an effort to decrease estrogen levels and potentially halt cancer growth. (10,11)
Uterine papillary serous carcinoma (UPSC) is an aggressive variant of endometrial cancer characterized by early metastasis, resistance to therapy, and a high mortality rate. Smaller studies suggest that HER-2/neu may be involved in the tumorigenesis of this disease.(13) Overexpression of the HER2/neu receptor in UPSC is an independent variable that is associated with a poorer overall survival, a worse overall prognosis, occurs more frequently in black women, and may contribute to racial disparity in survival. (12,13)
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer
- Medical subject headings
- Endometrial Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startJun 2003
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Funding and logistical difficuties resulted in the withdrawl of the study.
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 University of LouisvilleThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Sponsor
- Investigators
- Lynn P. Parker, MD, Principal investigator, University of Louisville, James Graham Brown Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375804
- Sponsor's protocol ID
- 357.03
- Status last verified
- Jan 2018
- First submitted
- 11 Sep 2006
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial Disparity in Prevalence and Survival Rates in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT00375804
- Acronym / sponsor ID
- 357.03
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding and logistical difficuties resulted in the withdrawl of the study.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Jun 2003
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Sep 2006 (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 objectives for this study:
- Investigate some of the causes for the racial disparity of endometrial cancer survival rates among black and white women
- Examine the biologic correlates of aggressive behavior such as estrogen receptor status, p53 and HER-2/neu overexpression, and aromatase activity
Detailed description
Endometrial cancer is the fourth most common cancer among women and the most common gynecologic cancer. Although the incidence of well-differentiated early stage endometrial cancer is higher among white women, there appears to be an increased incidence of aggressive variants with increased mortality rate among blacks.
Reported 5-year survival rate for white women with endometrial cancer is 90% while black women have only 60% survival. (1,2) Black women tend to have more aggressive cancers and more adverse symptoms such as non-endometrioid histology, grade 3 differentiation, and more stage III and IV cancers. (3,7) Many studies have identified and established risk factors and beneficial behaviors for endometrial cancer, most of which are modifiable. Some of the major risks include obesity, hypertension, high fat diet, diabetes, smoking, increased age, hormone replacement therapy, and tamoxifen use. Behaviors associated with decreased risks are use of oral contraceptives, breast feeding, and physical activity. (4)
There is also evidence that biologic factors may contribute to development of malignant endometrial neoplasms. Both mutation and over expression of the p53 tumor suppressor gene is seen in patients with endometrial cancer, especially those in the advanced stages.
Normally, increased levels of p53 are present in cells with damaged DNA. p53 triggers cells to produce more p21, a molecule that binds to cyclin-dependent kinase 2 (Cdk2). In the unbound state, Cdk2 allows cells to progress to the synthesis stage of the cell cycle; therefore, it remains arrested the Gı phase when it is coupled to p21 in an effort to prevent proliferation of abnormal cells. In addition to this mechanism, p53 is thought to be involved in induction of apoptosis. There are indications that black women may exhibit increased incidence of p53 over expression when compared to white women. (5,6,8)
Another biologic factor involved in endometrial cancer is the estrogen receptor. In contrast to p53, presence of estrogen receptors are a positive prognostic factor because they provide a potential avenue for treating endometrial carcinomas. However, the receptors must be functional in order to be advantageous. Some tumors contain mutated estrogen receptors, which cause changes in the metabolic pathway. Individuals with mutated receptors have varying susceptibilities to developing endometrial cancer. (9)
Aromatase is an enzyme involved in converting androgens to estrogens. Both estrogen and aromatase excess has been identified in endometrial cancer, while no aromatase activity has been indicated in the normal endometrium. Most of the aromatase activity appears to be confined to the stromal cells and is correlated with stromal invasion. It may be possible to inhibit aromatase in an effort to decrease estrogen levels and potentially halt cancer growth. (10,11)
Uterine papillary serous carcinoma (UPSC) is an aggressive variant of endometrial cancer characterized by early metastasis, resistance to therapy, and a high mortality rate. Smaller studies suggest that HER-2/neu may be involved in the tumorigenesis of this disease.(13) Overexpression of the HER2/neu receptor in UPSC is an independent variable that is associated with a poorer overall survival, a worse overall prognosis, occurs more frequently in black women, and may contribute to racial disparity in survival. (12,13)
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chart review of subjects diagnosed with endometrial cancer
Key inclusion criteria (1 listed)
- Patients diagnosed with a new case of endometrial carcinoma at the University of Louisville Hospital or in the Norton Healthcare system from 1995-2000
Key exclusion criteria (1 listed)
- Patients who do not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Funding and logistical difficuties resulted in the withdrawl of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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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.
Lynn P. Parker, MD principal investigator
University of Louisville, James Graham Brown Cancer Center
1 site 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 University of Louisville at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Funding and logistical difficuties resulted in the withdrawl of the study.). Results are not available in the source record.
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.
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 9 Jan 2018.