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| ID | Type | Description | Link |
|---|---|---|---|
| CRC 08108 | Other Identifier | Swedish Medical Center |
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Closed per local IRB due to advancements in standard ovarian cancer screening.
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| Name | Class |
|---|---|
| Fred Hutchinson Cancer Center | OTHER |
| The Marsha Rivkin Center for Ovarian Cancer Research | OTHER |
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The main purpose of this program is to see whether periodically measuring CA-125 (tumor marker) levels in the blood and undergoing transvaginal ultrasounds over time will be effective in the early detection of ovarian cancer.
The program will offer twice yearly CA-125 blood tests and annual transvaginal ultrasounds to monitor women at high risk for ovarian cancer. In addition to the main purpose of providing ovarian cancer screening, the researchers would also like to build a repository of blood specimens for use in ovarian and breast cancer research and to offer genetics counseling sessions to help educate women about risk-reducing options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ovarian Cancer Screening | Experimental | CA125 tumor marker, Transvaginal Ultrasound, Health Status Questionnaires |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Tumor Marker Analysis | Other | Performed every 6 months, these blood samples will be drawn to measure the concentration of CA125 tumor marker. Remaining samples will be stored in a specimen repository for use in future research for ovarian and breast cancer tumor markers. |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring for elevated levels of tumor marker CA-125 in the blood over time. | Average expected time of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Performing transvaginal ultrasounds to look for any abnormalities over time. | Criteria for an abnormal scan include 1) enlargement of one or both ovaries or 2) suspicious or indeterminate morphometric parameters, determined by the presence of intracystic papillations, and/or mural nodularity. Volume calculations will determine whether the ovary is enlarged. | Average expected time of 1 year |
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Inclusion Criteria:
Must meet one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Paley, MD | Swedish Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marsha Rivkin Center for Ovarian Cancer Research | Seattle | Washington | 98122 | United States |
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| Label | URL |
|---|---|
| Marsha Rivkin Center for Ovarian Cancer Research | View source |
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| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Transvaginal Ultrasound | Other | Performed annually, these pelvic ultrasounds will be used used to look for 1) enlargement of one or both ovaries or 2) suspicious or indeterminate morphometric parameters, determined by the presence of intracystic papillations, and/or mural nodularity. |
|
| Health Status Questionnaire | Other | Performed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history. |
|
| Performing health status questionnaires over time | Average expected time of 1 year |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |