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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-14231 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This study examines risk assessment and identifies prevention strategies for endometrial cancer. Collecting samples of blood and urine and risk assessments from patients with benign conditions or endometrial cancer may help doctors learn if there is a relationship between chronic inflammation and increase in risk for endometrial cancer.
PRIMARY OBJECTIVE:
I. To develop a model for a biobank that can be expanded across the Mayo Enterprise and implemented at extramural collaborative sites, including underserved populations.
OUTLINE: This is an observational study.
Patients complete a risk factor questionnaire over 15 minutes. Patients also undergo collection of blood and urine during pre-operative visit and collection of tissue samples at the time of surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (questionnaire, biospecimen collection) | Patients complete a risk factor questionnaire over 15 minutes. Patients also undergo collection of blood and urine during pre-operative visit and collection of tissue samples at the time of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood, urine, and tissue samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Levels of eicosanoids and specialized pro-resolving mediators (SPMs) in visceral adipose tissue (VAT) | Will compare eicosanoid and SPM levels by case-control status (women with endometrial carcinoma and women with non-cancerous conditions) in all patients with linear models, adjusted for age and body mass index (BMI) (and menstrual date, if needed). | Through study completion, up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ribonucleic acid (RNA) expression pathways related to inflammation in VAT | Will assess RNA data with cluster analysis and principal component analysis, focusing on inflammatory / immune pathways pathways in 10 patients with endometrioid endometrial cancer and 10 patients with benign conditions, frequency matched on age and body mass index (BMI). We will Will assess RNA expression patterns in relation to eicosanoid / SPMs that discriminate cases versus controls. |
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Inclusion Criteria:
Exclusion Criteria:
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Women undergoing hysterectomy at University of North Carolina (UNC) and Mayo Clinic, Florida
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| Name | Affiliation | Role |
|---|---|---|
| Mark E. Sherman, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Florida |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Blood, urine, tissue
| Questionnaire Administration | Other | Complete risk factor questionnaire |
|
| Through study completion, up to 24 weeks |
| Jacksonville |
| Florida |
| 32224-9980 |
| United States |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |